Re: Digest Number 959

[Guest guest]

Our son uses 4Life Transfer Factor Plus. According to their independent NK

cell activity study, Transfer Factor boosted activity by 103% while

colostrum resulted in 23% greater activity. Concentrated transfer factors

are extracted from cow colostrum. According to 4Life, colostrum contains

small amounts of transfer factor; bovine antibodies cause allergies in some

humans; bovine antibodies are species-specific--your body may not be able to

use it. Dr. Bock, Rhinebeck, NY, (among others) did a study using

Transfer Factor in his practice and says its the most exciting product for

the immune system he's seen in 18 years of practicing medicine. I met Dr.

Bock at an alternative medicine workshop recently and he stands by his

statement. We feel it's helped our son stay healthy and saw he was more

prone to colds, viruses last month when we stopped it in Dec. to chelate at

DAN doc's recommendation. We've recently started it again. We used

Kirkman's liquid colostrum prior to using Transfer Factor Plus. Wanda

Why are so many people using the 4-Life instead? Could someone who

uses this please clue me in on I must have missed.

[Guest guest]

Chris;

>A question for you if you can explain this: if OCD is an

>anxiety disorder, it seems like the symptoms would appear only during

>moments of stress, etc. But with it's like from the instant

>he wakes up until he goes to bed. I even noticed it when he sleeps,

>his hands moving, etc. So I guess I am trying to understand why if

>it's an anxiety disorder, it's there 24-hours. It seems like it

>would appear ONLY during stress/anxiety periods and not ALWAYS be

>there.

OCD can get worse during periods of stress, but it isn't external stress per

se that brings it on all the time. In my personal experience, the OCD is

more of an anxiety/stress generator than it is a reaction to real external

stressors.

For example, I may be feeling perfectly fine, relatively relaxed, watching a

TV show or something, when an OCD attack hits. There is usually something

in the environment that cues it (such as seeing a commercial for a show

about prisons), but the actual anxiety is generated by the OCD. Even if

that particular cue hadn't occurred at that moment, there's a good chance

that something else would set me off later (seeing a special report on

asbestos or something). If someone walked over and turned off the TV and

ended up breaking it somehow, then the OCD would probably get worse, because

the real external stress of having a broken TV would just add on to the

OCD-induced anxiety from the commercial.

I see OCD as an ongoing process. The " flavor " of it may differ from day to

day (which obsessive thoughts I have, which rituals I have to follow, how

anxious it makes me), but the fact that OCD is occurring is a constant.

Does that make sense?

[Guest guest]

;

I somewhat agree with that viewpoint, at least insofar as it relates to my

experience of OCD. It's one possible route to go when dealing with OCD, and

is similar in some ways to how I deal with mine.

I " fought " the OCD head on throughout my childhood and early teen years, and

it kept me worn out all the time. In my late teens and early adulthood, I

started using disassociation as another means of controlling it (not a route

that I would suggest to anyone). In my later 20's on into my 30's I've

learned to (sometimes) let it " wash through me, " so to speak. I try to

think of my core self - the " me " that isn't the OCD - as a net rather than a

fortress wall. When the obsessions and compulsions are hitting hard, I

concentrate on holding the rational bit of me together, and let the anxiety

and thoughts run their course. It's a bit like the tree bending in the wind

analogy - sort of Taoism for OCD. When that doesn't work, I step back and

return to picking my battles wisely.

It's very easy to have that sort of visualization (the whole " net " thing)

slip into disassociation, though, so I have to be very careful with it.

I'm not sure that that sort of approach would be as effective with kids -

it's a very abstract way of dealing with the OCD. I've coached my

girlfriend in it, but she's in her 40's and loves Eastern philosophy so it's

a natural fit for her. Kids are still struggling with concepts of the

" self " and the " other, " and might find such abstractions to be confusing.

It all gets down to what's right for the individual sufferer, though.

I'll have to take a look at that book.

-

------------------------------------------

Just an interesting view as expounded in the book Stop Obsessing.

Our children are often taught to " battle " the thoughts... " slay the

dragon " . " It's not me, it's OCD " etc. Challenge challenge

challenge.... fight, fight etc.

These methods to separate OCD have been very useful, of course.

Our children have to understand that they are NOT their thoughts, but

that they are something unharmable and beautiful...greater than just

the flow of thoughts that pass through. So they battle those " nasty "

thoughts.

At some point though, perhaps they need to accept these thoughts,

allow them, not run from them or " kill them " . Research has shown that

this type of resistance may actually reinforce the obsessive thinking.

This is kind of a paradoxical approach, but one that seems worthy of

incorporating. In order to get rid of obsessional thoughts, one

becomes willing to accept them. The author suggests that the inner

response is, instead of " I can't let myself start obsessing now, it

would be awful, " you take the position, " It's OK for me to be

obsessing right now. "

This response must be linked to the acceptance that ritualizing is not

the only way to reduce distress. That understanding and meeting your

worries is the route to making them have less power.

Please understand that these comments are somewhat paraphrased from

the book and that the truth of the method needs expansion by the

authors (Foa & ).

[Guest guest]

From the mouths of babes.

-

------------------------------

My son says OCD is not like getting into a swimming pool and acclimating

quickly. It is more like jumping into Arctic waters.

[Guest guest]

>This is kind of a funny one - she always has to be

>second everywhere! In the car, out of the car, in the house, second

>to pray at family devotions, you get the idea

She's just being smart. If the wolf is in front of you, the first person

through the door gets eaten. If the wolf is behind you, the last one gets

eaten. She's safest in the middle. )

- (just kidding)

[Guest guest]

PLEASE CHANGE MY ADDRESS,

kenny.copeland@...

THANKS KENNY

[Guest guest]

hi my nane is shirley and i want to ask something ok well lateley i

have nostice thath iam getting more trie and even when iam on the web

somtime i just fall a sleep and now they pain is gettingworst this thime

and my kidney are realy huring me to much and i notice thath there was

blood when i went to the bathroom iam going to see they dr and see

what he has to say and thath why i lost my job i just could not keep up

with it any more i hoe iam not boring anybody hear but

you are they peolpe that unstand my family realy does unstand at all

they try but they realy unstand thank you

[Guest guest]

Hi Shirley,

Let us know what the doctor says ok?

alley

[Guest guest]

Hi Shirley....

No, no one really understands except those of us who are living it. They try but

they just can't possibly have a concept of what we experience. I think that is

why those of us with Hep C bond so tightly...we do understand and we also

understand that others don't understand.

Your falling asleep all the time...I experienced that. I'd be at work typing and

all of a sudden someone would be waking me up...my hands would still be on the

keyboard but I'd be sound asleep. In my case it was my thyroid...my TSH was up

to 110 (normal is .5 to 5.5). So do make sure that get's checked.

And you are so right to get in to see a doctor...blood in the urine is not a

good thing. And pain in the kidney area is not a good thing. Claudine, our

expert in Doc's absence, knows more about the connection between hep c and the

kidneys...I don't know anything. It's good you are getting things checked.

And don't ever worry about boring us...we are here to support each other and we

understand because we have all been there at one time or another or still are.

So lean on us all you need to. And do let us know what the doctor says...we all

care.

Blessings

Tatezi

Re: Digest Number 959

hi my nane is shirley and i want to ask something ok well lateley i

have nostice thath iam getting more trie and even when iam on the web

somtime i just fall a sleep and now they pain is gettingworst this thime

and my kidney are realy huring me to much and i notice thath there was

blood when i went to the bathroom iam going to see they dr and see

what he has to say and thath why i lost my job i just could not keep up

with it any more i hoe iam not boring anybody hear but

you are they peolpe that unstand my family realy does unstand at all

they try but they realy unstand thank you

[Guest guest]

Dear All, please find attached an invite to the launch of 'Practice Development in Community Nursing' which we are holding in Beverley, East Yorkshire on Friday 20th June. The invite is in powerpoint. All colleagues in the Yorkshire, Lincs and the North East are very welcome (as are others!). Hopefully this will get to people like Caroline Plews for whom I do not have an email address. Thanks, Ros

Digest Number 959

[Guest guest]

This is really useful. I haven't received a digest before..how do I make sure about continuing to receive them..mind you,

since I've had a psychic reading..I should already know the answer..in fact I had a psychic girlfirend once, but she left

me before I asked her out?

Digest Number 959

[Guest guest]

go to the Senate web page, and follow the 'members' link until you

find your name. You can then alter the settings, so that you receive either

individual emails or a daily digest of messages sent in the previous 24

hours (no mail and special notices only are other alternatives). Daily digests

come without attachments, so you need to go the web page and follow the 'messages'

link, then download any attachments from there if you want them. best wishes

Manning wrote:

RE: Digest Number 959

This is really useful. I haven't received a digest

before..how do I make sure about continuing to receive them..mind you,

since I've had a psychic reading..I should already

know the answer..in fact I had a psychic girlfirend once, but she left

me before I asked her out?

[Guest guest]

Dear

Thanks

Chris

-----Original Message-----From: Cowley [mailto:sarah@...]Sent: 15 June 2003 20:24 Subject: Re: Digest Number 959 go to the Senate web page, and follow the 'members' link until you find your name. You can then alter the settings, so that you receive either individual emails or a daily digest of messages sent in the previous 24 hours (no mail and special notices only are other alternatives). Daily digests come without attachments, so you need to go the web page and follow the 'messages' link, then download any attachments from there if you want them. best wishes Manning wrote:

This is really useful. I haven't received a digest before..how do I make sure about continuing to receive them..mind you,

since I've had a psychic reading..I should already know the answer..in fact I had a psychic girlfirend once, but she left

me before I asked her out?

[Guest guest]

In a message dated 2/14/04 3:41:25 AM Mountain Standard Time,

SSRI medications writes:

> Professor , who was involved in clinical trials of duloxetine at

> Sydney's Prince of Wales and St hospitals, said the compound was

> revolutionary and offered the first effective drug treatment for stress

> incontinence - estimated to affect at least 78 million women over the age of

>

> 20 worldwide.

>

Here it is! 78 million women who pee their pants when laughing, snorting,

coughing, will now be offered this wonderful panacea and not be told, in all

probability, that it's really a brain-altering antidepressant with suicide as a

side effect. Also, let's face it, Dr. is a whore for the pharmas if she

conducted the clinical trials. She's not about to bite the hand that feeds

her. Yes, her comments are illogical, to the max. And a freaking insult to any

of us who know the other side of the coin. Do you have an e-mail address,

? She's on my list and will also get a letter from me..

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

[Guest guest]

In a message dated 2/14/04 3:41:25 AM Mountain Standard Time,

SSRI medications writes:

> Lilly, in its preliminary review, concluded that duloxetine did not cause

> her death.

>

> …As it relates it specifically to duloxetine, we have not seen anything at

> all from the data that either being on the drug or being withdrawn would

> pose a suicide risk, " said.

>

>

Uh, well, then, how do they explain 5 dead guinea pigs??? HUH? Anyone got

an answer for that? Talk about spinning. A girl hangs herself DURING the

clinical trial after being on high doses of this drug, but the drug had nothing

to

do with it. I can't believe the outright LIES they tell.

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

[Guest guest]

In a message dated 2/14/04 3:41:25 AM Mountain Standard Time,

SSRI medications writes:

> Let's see. 15 studies -- 3 positive, 2 inconclusive and 10 (count 'em

> 10) negative. But we are cautioned about believing the NEGATIVE

> trials because they may, for some reason, be invalid studies. But we

> aren't cautioned about believing the POSITIVE. Now why is that???

> _________________

>

Because they expect people to not understand the irrationality of what

they're saying. After all, half the population is doped up and one of the side

effects of these drugs is disruption of cognitive thought! LOL

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

[Guest guest]

In a message dated 2/14/04 3:41:25 AM Mountain Standard Time,

SSRI medications writes:

> Let's see. 15 studies -- 3 positive, 2 inconclusive and 10 (count 'em

> 10) negative. But we are cautioned about believing the NEGATIVE

> trials because they may, for some reason, be invalid studies. But we

> aren't cautioned about believing the POSITIVE. Now why is that???

> _________________

>

Because they expect people to not understand the irrationality of what

they're saying. After all, half the population is doped up and one of the side

effects of these drugs is disruption of cognitive thought! LOL

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

[Guest guest]

And get away with it.

--- glitterari@... wrote:

---------------------------------

In a message dated 2/14/04 3:41:25 AM Mountain

Standard Time,

SSRI medications writes:

> Lilly, in its preliminary review, concluded that

duloxetine did not cause

> her death.

>

> …As it relates it specifically to duloxetine, we

have not seen anything at

> all from the data that either being on the drug or

being withdrawn would

> pose a suicide risk, " said.

>

>

Uh, well, then, how do they explain 5 dead guinea

pigs??? HUH? Anyone got

an answer for that? Talk about spinning. A girl

hangs herself DURING the

clinical trial after being on high doses of this drug,

but the drug had nothing to

do with it. I can't believe the outright LIES they

tell.

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

[Guest guest]

Chris' had a reaction to haldol and risperdol, so they

had to give him benedryl. He cannot use these drugs.

His tongue protruding (HOW DISGUSTING)while trying to

introduce a new anti-psychotic. Attempted to commit

suicide or was trying to kill me (not sure which)

after stopping a cocktail of 4 drugs and introducing 2

other's, which were not the correct drug. What a

freeking nightmare! Did i tell you guys that he

decreased his medicine? Actually, he stopped it cold

turkey, but realized a few days later that something

wasn't right, so he took 5 mg's in the middle of the

night on his own. He is now on only 2.5 mg's Zyprexa

and i think he is hearing voices again. Hopefully,

this will pass. Last time we decreased, we started

loosing him at the 2 week mark. Again, 2 weeks into it

and we see problems developing. He was doing GREAT

until then. It makes me wonder (and i have heard of

this before) if taking this trash every other day

would be as effective as taking it every day.

Connie

--- glitterari@... wrote:

---------------------------------

In a message dated 2/14/04 3:41:25 AM Mountain

Standard Time,

SSRI medications writes:

> NEVER seen in that

> hospital what i have witnessed in my own house. Why?

>

>

Most of the kinds of symptoms you describe happen when

the medication is

reduced or withdrawn. No doubt that isn't happening

in the mental hospital.

Blind Reason

a novel of espionage and pharmaceutical intrigue

Think your antidepressant is safe? Think again.

[Guest guest]

Here is a research study on follow up spinal fusions.

The fate of the adjacent motion segments after lumbar fusion.

Gillet P.

Orthopaedic Department, University Hospital, Liege, Belgium.

phgilletortho@...

Lumbar spine fusion is a commonly performed procedure in various pathologic

conditions of the spine. Its role remains debated, and moreover, delayed

complications may occur, among which is transitional segment alteration

leading to recurrence of back pain, gross instability, and neurologic

symptoms. Little is known about the long-term prevalence of this

complication because of a lack of specific studies. We analyzed the fate of

the transitional segments in a homogeneous group of patients operated on

during a 14-year period for degenerative conditions of the lumbar spine

resistant to conservative treatment. Follow-up ranged from 2 to 15 years.

Seventy-five percent of our study group had a minimal 5-year follow-up. In

this subgroup, 41% of the patients developed transitional segment

alterations, and 20% needed a secondary operation for extension of the

fusion. Potential risk factors such as postoperative delay, length of

fusion, and spine imbalance were recognized. The frequency of delayed

alterations of the adjacent segment and the severity of symptoms related to

this complication in this study raise questions about the justification of

fusion procedures in degenerative conditions of the spine without

threatening instability. Data from the literature confirm the severity of

the problem, but many uncertainties remain because of the lack of

homogeneous and complete data on both the normal evolution of motion

segments of the lumbar spine with age and the fate of the same segments when

transformed in transitional segments. Future prospective studies on the

subject are needed and must deal with homogeneous groups of patients. More

reconstructive surgical procedures need to be developed to lessen the need

for fusion procedures.

Publication Types:

Evaluation Studies

PMID: 12902949 [PubMed - indexed for MEDLINE]

Roy Brown, Jr., D.C.

14391 Manchester Rd.

Manchester, MO 63011

636-230-3783

drbdc@...

www.ChiroDoc.Org

[Guest guest]

This may be the last e-mail i send out for a while, until i get my computer

fixed, but i wanted to say that i waited up till 3am hoping that at

midnight they would just turn on the pass/fail link...no dice get up for

work at 10am, Still NOTHING i had to work an entire 8 hour shift before i

get home now and found out i too am now PTCB Cert. Congrats to all Bell

well and make the world a better place! Thanks for all the help and letting

me vent :-) ps as there any other forums that just have techs, not so much

geared towards the test passing where i can vent my anger at evil corporate

America and stuff like that please e-mail and let me know whom i should

join THANKS a million Best of luck all

-- B. MacLeod CPht

[Guest guest]

>From: Lexapro

>Reply-Lexapro

>Lexapro

>Subject: Digest Number 959

>Date: 2 May 2005 09:39:09 -0000

>

>

>There are 10 messages in this issue.

>

>Topics in this digest:

>

> 1. Any ideas on how to cope in the meantime?

> From: " rachelm1965 " <racheld1965@...>

> 2. New To Lex And A Question

> From: " netcandee " <netcandee@...>

> 3. Re: New To Lex And A Question

> From: " rachelm1965 " <racheld1965@...>

> 4. Re: (Lexapro) question--Lexapro to Celexa?

> From: " rachelm1965 " <racheld1965@...>

> 5. Weaning off Lex

> From: " stitchme.geo " <stitchme@...>

> 6. Re: New To Lex And A Question

> From: " lagunandn " <lagunandn@...>

> 7. Re: Re: (Lexapro) question--Lexapro to Celexa?

> From: " terry " <terry120953@...>

> 8. Does Celexa Work For Anxiety?

> From: " lagunandn " <lagunandn@...>

> 9. Re: Does Celexa Work For Anxiety?

> From: " Barbara " <bjarrett@...>

> 10. Re: Does Celexa Work For Anxiety?

> From: " Cathrine " <book_snail@...>

>

>

>________________________________________________________________________

>________________________________________________________________________

>

>Message: 1

> Date: Sun, 01 May 2005 14:09:20 -0000

> From: " rachelm1965 " <racheld1965@...>

>Subject: Any ideas on how to cope in the meantime?

>

>I have been on lexapro for a week, after the crap hit the fan last

>Sunday, and I ended up going to the emergency room. I had been on

>effexor for a few years with decent results, except I was really fat

>and sleepy. SO I went off if it, intending to get on something

>different, but I took too long getting it taken care of, and ended

>up in full panic mode. I suffer from depression, panic attacks and

>GAD. I think it's helping, but I still feel pretty horrible. I was

>given tranquilizers to take, but I think they are making the

>depression worse--so I am not taking them. My anxiety is just below

>panic level, so I am trying to decide which is worse--depression or

>anxiety. I am going to go to work tomorrow. I just dread it, but I

>can't afford to be off of work anymore.

>

>Any ideas on how I can more easily face my responsibilities? I

>almost feel ridiculous even asking, as my guess it's just a matter

>of sheer willpower. Or how to handle trying to figure out how to

>get through the time it will take for the lexapro to kick in better

>(if it will). I'm feeling pretty desperate right now, as you can

>probably tell.

>

>Hi

You sound a lot like me except I have horrible fatigue as well. It may

sounfd to simple but what helps me a ton with anxiety and depression is

excercise. I do my stair-stepper for 20-60 minutes before i go to work and

it takes the edge of the anxiety and depression, and also gives me a sense

of confidence and well being. I seriously doubt i could have made it this

far and kept a job without excercise. the other Thing that helps me is high

dose fish oil. there is a lot of good scientific data on how this helps

depression and anxiety. I usually feel better about 20 minutes after taking

them. Another thing that helps is I used to drink lots of regular and diet

pop and when i started my new job they had a purified water cooler. I

noticed that drinking a ton of purified water cleared my head and helped my

anxiety.

I know these things sound simple but sometimes the simple things are the

best. And at least all of thee things are healthy, aren't going to give you

and side effects and are free or cheap.

Good luck and let us know how you are doing. Jeff

>

>

>

>

>

[Guest guest]

Jeff--thanks for the info. I actually have been taking fish

oil at my counselors reccomendation and exercising mildly.

I also GOT OFF of lexapro, switched back to effexor and am

making use of my anti-anxiety meds. I feel way better than

I did last week! thanks for your thoughts--they are

definitely legitimate helps. R

[Guest guest]

> 4. New Quadruple Vaccine

> From: " Mita Gibson " <msgibson@...>

>

>Message: 4

> Date: Thu, 2 Feb 2006 11:47:17 -0500

> From: " Mita Gibson " <msgibson@...>

>Subject: New Quadruple Vaccine

>

>

>

>Our pediatrician recently informed me that there will soon be a new,

>combined MMR-chicken pox vaccine. It has already been decided that this

>new,

>quadruple-dose vaccine will be routinely administered in place of the old

>MMR vaccine. My older daughter was diagnosed with autism last year at age

>five. My younger daughter is seventeen months and has not received the MMR

>vaccine yet. Does anyone know if there is published research on the new

>vaccine?

>

It's not a new vaccine, they are just combining existing vaccines. Just

like they combined the measles mumps and rubella vaccines into one, they are

now doing the same w/the MMR-V

To be honest with you, if I had any health issues in my family, I would

definitely decline these vaccines, as they are only tested in HEALTHY

children.

Here's just a bit of info I have been gathering about the combined MMR-V

It's believed they combined these to work up to a 2 dose schedule for the

chickenpox vax because it appears the single dose is pretty much useless.

There have been several outbreaks among the vaccinated in daycares across

the country. One outbreak originated from a vaccinated 4 yr old, so much

for blaming the spread of disease on the unvaccinated!

*************************************************************

Manufacturers push forward with development of new vaccines

The Pediatric Infectious Disease Journal: Volume 16(7) July 1997 pp 662-667

http://www.pidj.com/pt/re/pidj/selectreference.htm;jsessionid=CjGQ9R2J5qinfKHPRa\

S4rpQ2Bv2Z5DBRJbQ2idSyKisUQzQuNi27!1142682874!-949856032!9001!-1?an=00006454-199\

707000-00008 & id=P70 & data=00004807_1990_32_189_wasmuth_immunosorbent_%7C00006454-\

199707000-00008%23xpointer(id(R14-8))%7C1033910%7C%7Covftdb%7C

Safety and immunogenicity of concurrent administration of

measles-mumps-rubellavaricella vaccine and PedvaxHIB® vaccines in healthy

children twelve to eighteen months old

REUMAN, PETER D. MD, MPH; SAWYER, MARK H. MD; KUTER, BARBARA J. PHD, MPH;

MATTHEWS, HOLLY MS; THE MMRV STUDY GROUP

From the University of Florida, School of Medicine, Gainesville, FL (PDR);

the University of California, San Diego, School of Medicine, La Jolla, CA

(MHS); and Merck Research Laboratories, West Point, PA (BJK, HM).

Accepted for publication March 20, 1997.

Address for reprints: D. Reuman, M.D., M.P.H., Associate Professor of

Pediatric Infectious Diseases, Division of Pediatric Infectious Diseases,

Department of Pediatrics, University of Florida, College of Medicine,

Gainesville, FL 32610. Fax 352-846-0619; E-mail

REUMAN.PEDS@....

Abstract

Objective. To determine the safety and immunogenicity of concurrent

administration of measles-mumps-rubella-varicella vaccine (MMRV) and

PedvaxHIB® (Haemophilus influenzae type b conjugate vaccine) vs. M-M-R®II

and PedvaxHIB® followed by an optional dose of VARIVAX® 6 weeks later.

Design. Healthy children, 12 to 18 months of age, were randomly assigned to

two groups to receive (1) MMRV and PedvaxHIB® given concurrently or (2)

M-M-R®II and PedvaxHIB® followed by an optional dose of VARIVAX® 6 weeks

later.

Subjects. The study group included 294 healthy children, ages 12 to 18

months, with a negative history of measles, mumps, rubella and varicella.

Main outcome measures. The seroconversion rate and magnitude of antibody

responses when MMRV was given concurrently with PedvaxHIB® compared with the

antibody responses when VARIVAX® was given 6 weeks after M-M-R®II and

PedvaxHIB®.

Results. Healthy children, 12 to 18 months of age, who received MMRV and

PedvaxHIB® concurrently showed immune responses similar to those in the

control group who received M-M-R®II vaccine with PedvaxHIB® followed by

VARIVAX® 6 weeks later. Antibody titers for varicella were significantly

lower when MMRV was administered than when varicella vaccine was given

separately (0.712-fold difference, P = 0.028). No vaccine-related serious

adverse reactions were reported, and no clinically significant differences

were seen in the safety profiles of the two treatment groups.

Conclusions. There were no statistically significant differences in the

seroconversion rates between the two treatment groups for any of the

antigens tested at 6 weeks and 1 year.

Significantly lower geometric mean titers for varicella were noted in the

group who received MMRV compared to VARIVAX® given alone.

Six-week seroconversion rates, persistence of immune responses at 1 year and

the frequency of local and systemic reactions were comparable when MMRV was

administered with PedvaxHIB® compared with M-M-R®II and PedvaxHIB® followed

by VARIVAX® 6 weeks later.

INTRODUCTION TOP

The Childhood Immunization Initiative, a national program to improve

immunizations for children, has made a priority of introducing new vaccine

immunogens and developing means for immunizing children with fewer

injections and fewer health care visits.1, 2 The availability of an

effective combined measles, mumps, rubella and varicella vaccine (MMRV)

would facilitate the immunization of children against all four diseases and

improve vaccination rates.

M-M-R®II vaccine has been a licensed product in the United States since

1979, has had a good safety and tolerability profile and elicits long term

protective immunity. VARIVAX® has been licensed since 1995 and was evaluated

in clinical trials beginning in 1981. Clinical trials testing the safety and

tolerability of the monovalent, live, attenuated varicella vaccine have

shown the vaccine to be generally well-tolerated, immunogenic and 98%

efficacious (through two varicella seasons) in a double blind,

placebo-controlled, randomized study.3-6 A rash rate of & #8764;4% has been

noted in healthy vaccinated children and adolescents in the first 6 weeks

after vaccination. Approximately 1 to 2% of vaccinated children per year

develop varicella that is less severe than natural disease. Vaccine-induced

rash and disease after immunization have been mild and self-limited.7, 8

An investigational quadrivalent vaccine adding varicella to M-M-R®II (MMRV)

has been given to >400 healthy children ages 15 to 23 months and was found

to be generally well-tolerated and immunogenic.9-11 In studies in which MMRV

was compared with M-M-R®II followed by varicella given 6 weeks later

(M-M-R®II + V), virtually 100% of children in both groups seroconverted at 6

weeks for all four virus components.10, 11 Clinical reactions in both groups

were similar.

In a study in which PedvaxHIB® was administered concurrently with M-M-R®II

(using separate sites and syringes), no impairment of immune response to

individually tested vaccine antigens was found.12 One hundred percent (44 of

44) of children had antipolyribosylribitol phosphate (PRP) titers of >0.15

& #956;g/ml. The seroconversion rates were 96% (47 of 49) for measles, 100%

(42 of 42) for mumps and 100% (47 of 47) for rubella. The type, frequency

and severity of adverse experiences observed in this study were similar to

those seen when the vaccines were given alone.12

This study was designed to determine whether concurrent administration of

MMRV with PedvaxHIB® (7.5 & #956;g, liquid) was as immunogenic and as

welltolerated as when M-M-R®II was administered simultaneously with

PedvaxHIB® and an optional dose of VARIVAX® was administered 6 weeks later.

METHODS TOP

Study design. This multicenter study was performed at six sites after

obtaining written approval from the institutional review board of each

participating principal investigator and institution. Informed consent was

obtained from each subject's parent/guardian before entry into the study.

Healthy children, ages 12 to 18 months, with a negative history for measles,

mumps, rubella, Haemophilus and varicella disease were eligible for the

study providing they received two vaccinations with PedvaxHIB® before 7

months of age. Subjects were excluded from the study if they had received

measles, mumps, rubella or varicella vaccines or if they had

immunodeficiency, neoplastic disease, immunosuppressive therapy, sensitivity

to vaccine contents or a fever at the time of vaccination. Subjects were

also excluded if they had received another vaccine within 2 weeks or within

1 month after injection or had received a blood product within the last 3

months. Salicylates were contraindicated during the 6 weeks after

vaccination. Eligible subjects were randomized to receive one of the two

vaccine regimens. Randomization was done separately within the six study

centers stratified on age (12 to 14 months and 15 to 18 months). Blood

samples were obtained from participating children within 2 weeks before the

first injection, 6 weeks after each vaccination and 1 year later to

determine the immunogenicity of the vaccines.

Vaccines and clinical supplies. M-M-R®II (measles, mumps and rubella

vaccine). M-M-R®II is a sterile, lyophilized, live virus vaccine for

immunization against measles, mumps and rubella and contains no

preservatives. A 0.5-ml dose of vaccine contains & #8764;25 & #956;g of

neomycin. M-M-R®II was stored in a refrigerator at 2-8°C.

VARIVAX® (varicella virus vaccine live, OKA/Merck strain, lyophilized).

Varicella vaccine is a cell-free preparation of live Oka strain varicella

zoster virus that contains & #8805;1000 plaque-forming units/0.5 ml. A 0.5-ml

dose of vaccine contains & #8764;1 to 5 & #956;g of neomycin. Varicella

vaccine was stored frozen at -20°C until reconstituted.

MMRV (measles, Enders' attenuated Edmonston strain; mumps, Jeryl Lynn

strain; Rubella-Wistar RA27/3; varicella, Oka/Merck strain), lyophilized.

MMRV is a sterile, lyophilized, live virus vaccine for immunization against

measles, mumps, rubella and varicella and contains no preservatives. A

0.5-ml dose of MMRV contains & #8764;25 & #956;g of neomycin. The varicella

component of the MMRV used in this study contained a new stabilizer and was

prepared by one additional passage in human embryonic lung fibroblasts

(MRC-5). The M-M-R®II component was the same as the currently marketed

product. MMRV was stored frozen at -20°C until reconstituted.

PedvaxHIB® (Haemophilus b conjugate vaccine, liquid). Each 0.5-ml dose of

PedvaxHIB® vaccine contains 7.5 & #956;g of Haemophilus b polysaccharide, 125

of & #956;g Group B meningococcal outer membrane protein, 0.2 mg of aluminum

and thimerosal at 1/20 000. The vaccine was stored at 2 to 8°C.

MMRV, M-M-R®II and varicella vaccines were administered as a 0.5-ml

subcutaneous injection into the right deltoid or anterolateral thigh.

PedvaxHIB® was administered as a 0.5-ml intramuscular injection into the

left deltoid or anterolateral thigh.

Safety and tolerability evaluations. All participants were followed for 6

weeks after each vaccination, and the parent/guardian was asked to record

temperatures and all local and systemic complaints on a report card and to

report immediately any unusual reactions, high fever ( & #8805;38.9°C, oral)

or rash to the study physician. Parents were requested to have all children

who developed a rash seen by study personnel to document both clinical

findings and child's history of exposure. If a rash was reported the

participant was examined daily by study personnel until the rash resolved.

After additional informed consent was obtained, acute and/or convalescent

blood samples as well as appropriate cultures were obtained. At 1 year blood

was drawn to evaluate antibody persistence, and parents were asked to

complete a survey to obtain information on disease and exposures.

Laboratory analyses. All individuals with an adequate volume of serum were

tested for measles, mumps, rubella, varicella and anti-PRP antibodies by

Merck Research Laboratories, West Point, PA. The measles enzyme-linked

immunosorbent assay (ELISA) is a modification of the Measelisa II® test kit

(Whittaker Bioproducts, sville, MD). The rubella ELISA is a

modification of the Rubazyme® kit (Abbott Laboratories, Chicago, IL). The

assay for mumps is a modification of an ELISA previously described.13 Titers

& #8805;5.0, & #8805;2.0 and & #8805;8.0 units were considered positive for

measles, mumps and rubella viruses, respectively. Antibodies to

varicella-zoster virus (VZV) were measured by a glycoprotein ELISA

previously described.14 A positive result was a calculated end point titer

of & #8805;0.625. Antibodies to H. influenzae type b capsular polysaccharide

were evaluated using PRP-radioimmunoassay.15

Data analyses. Immunogenicity analyses were evaluated per-protocol and

safety analyses were performed for any subject with follow-up. For live

virus components the primary immunogenicity end point was 6-week

seroconversion rates as defined by positive antibody titer and geometric

mean titers (GMTs) in subjects who were initially seronegative for that

component. The proportion of subjects with anti-VZV gpELISA titers of

& #8805;2.6 and & #8805;5.0 also were summarized. For PedvaxHIB®, a booster

vaccination, the primary end point was GMT. Tests were two-sided at alpha =

0.050. No multiplicity adjustment was made in the nine computed P values

calculated from the primary end points.

Assuming a 95% response in the control arm, the study could detect a 10%

point difference in seroconversion rates with 80% power in 140 subjects per

group. For GMTs the power to detect a 2-fold difference was 98% assuming a

standard deviation of 4-fold.

Cochran-Mantel-Haenszel, stratifying on age and study center, was used to

test for differences in seroconversion rates between treatment groups. Log

titers were compared using a general linear model with terms for center and

age category (general linear model in SAS V6.04). The analysis of anti-PRP

titers also included the log prevaccination titer as a covariate.

Interaction between treatment group and terms in the model were investigated

at alpha = 0.100. Safety parameters were compared using Fisher's exact test.

RESULTS TOP

Immunogenicity. There were no statistically significant differences in

seroconversion rates between the two treatment groups for any of the four

viral components (Table 1). Measles GMTs in those receiving MMRV plus

PedvaxHIB® (Group A) were significantly higher than those receiving M-M-R®II

and PedvaxHIB® (Group (1.392-fold difference, P = 0.004), and antibody

titers for varicella were significantly lower in vaccinees in Group A than

in those in Group B (0.712-fold difference, P = 0.028). The two groups had a

marginally nonsignificant difference for rubella (1.176-fold difference

favoring Group A, P = 0.088).

Because the 6-week titer has been shown to inversely correlate with

breakthrough varicella infection, the proportion of initially seronegative

subjects with 6-week varicella gpELISA titers & #8805;2.6 and the proportion

of subjects with varicella gpELISA titers & #8805;5.0 were compared between

Group A and Group B. Subjects with a titer of & #8805;2.6 in Group A numbered

83 of 94 (88.3%) compared with 81 of 86 (94.2%) of subjects in Group B.

Subjects with a titer of & #8805;5.0 accounted for 71 of 94 (75.5%) compared

with 74 of 86 (86.1%). There were no statistically significant differences

between these groups for either comparison.

For PedvaxHIB®, the GMTs adjusted for the natural log of the prebooster

titer level were compared between treatment groups for all subjects

regardless of prebooster values. Of 135 Group A subjects the

PRP-radioimmunoassay pre-GMT was 0.33, the 6-week GMT was 4.92, and the

adjusted GMT was 5.07. Of the 123 Group B subjects the PRP-radioimmunoassay

pre GMT was 0.36, the 6-week GMT was 5.09 and the adjusted GMT was 4.93. The

geometric mean fold difference between Group A and Group B was 1.028 (95%

confidence interval, 0.726, 1.457). The two groups were not significantly

different with respect to GMTs adjusted for the natural log of the

prebooster titer level.

In addition the proportion of subjects with anti-PRP titers >0.15 & #956;g/ml

and >1.0 & #956;g/ml 6 weeks postvaccination were summarized by treatment

group. Group A subjects with anti-PRP titers of >0.15 & #956;g/ml numbered

130 of 135 (96.3%) compared with 116 of 123 (94.3%) Group B subjects who

were given VARIVAX® 6 weeks later. Group A subjects with anti-PRP titers of

>1.0 & #956;g/ml were 109 of 135 (80.7%) compared with 106 of 123 (86.2%) of

Group B subjects. There was no significant difference between the two groups

using either cutoff value.

Persistence of antibody response & #8764;1 year after the first injection is

shown in Table 2. There were no significant differences between the two

groups in persistence of antibody rates to measles, mumps, rubella and

varicella.

Safety. No vaccine-related serious adverse reactions were reported. Local

reactions are summarized in Table 3. There was no statistically significant

difference between the proportion of subjects reporting a local reaction at

the MMRV injection site and the proportion reporting a local reaction at the

M-M-R®II injection site. There was also no statistically significant

difference between the two treatment groups in the proportion of subjects

reporting a local reaction at the PedvaxHIB® injection site. However, there

was a significantly higher proportion of subjects reporting a local reaction

at the MMRV injection site than at the VARIVAX® injection site (20.4% vs.

9.4%, P = 0.018), suggesting that the difference in local reactions between

MMRV and varicella vaccine alone is primarily the MMR component. Comparisons

were not done for the individual local reactions.

In the two groups the proportion of subjects reporting a

measles-like/rubella-like rash and the proportion of subjects reporting a

varicella-like rash were compared. Measles-like/rubella-like rashes were

noted in 8 of 147 (5.4%) Group A subjects and 6 of 147 (4.1%) Group B

subjects after the first combined vaccination and in 1 of 127 (0.8%) after

VARIVAX®. A varicella-like rash was observed in 4 of 147 (2.7%) Group A

subjects and 1 of 147 (0.7%) Group B subjects after the first combined

vaccination and in 2 of 127 (1.6%) after VARIVAX®. There were no

statistically significant differences between treatment groups for any of

the comparisons.

The proportion of subjects reporting a maximum temperature of & #8805;38.9°C

(oral) was 41 of 140 (29.3%) for MMRV plus PedvaxHIB® (Group A), 38 of 141

(27.0%) for the M-M-R®II plus PedvaxHIB® (Group and 32 of 126 (25.0%) for

the VARIVAX® visit of Group B. There were no statistically significant

differences between treatment groups for any of the comparisons.

Varicella cases. Two cases of varicella were reported & #8805;6 weeks after

varicella vaccination. Both of these cases were subjects in Group B

(M-M-R®II plus PedvaxHIB® with VARIVAX® 6 weeks later). These rashes

consisted of 10 and 40 lesions, respectively. One subject reported a maximum

temperature of & #8805;102°F, oral; the other child reported a normal

temperature concomitant with the rash.

DISCUSSION

The administration of MMRV and PedvaxHIB® was generally safe and

well-tolerated. No vaccine-related serious adverse reactions were reported

and no clinically significant differences were seen in the safety profiles

of the two treatment groups. There were no statistically significant

differences in the seroconversion rates between the two treatment groups for

any of the antigens tested. The two groups were similar with respect to

anti-PRP GMTs adjusted for the natural log of the prebooster titer

indicating no interaction when varicella virus is given concomitantly with

PedvaxHIB®.

There were significantly lower GMTs for varicella in the group that received

MMRV. This has been a consistent finding in other published Phase III

studies with MMRV.11 Varicella vaccine does not appear to interfere with the

immunogenicity of measles, mumps, rubella and Hib vaccines as indicated by

this and other published studies.11 Seroconversion rates appear similar for

all four antigens at 6 weeks and at 1 year.

There were significantly higher GMTs for measles in the group who received

MMRV although there was no difference in seroconversion rates. A

significantly higher GMT has not been found in other studies with this

vaccine (unpublished data, Merck).11

In summary humoral seroconversion rates, the persistence of immune responses

at 1 year and the frequency of local and systemic reactions after

administration of the combined vaccine MMRV were comparable with

seroconversion when M-M-R®II and PedvaxHIB® were administered concurrently

followed by VARIVAX® 6 weeks later. Further studies are planned to

incorporate a better stabilizer and higher titers of varicella vaccine virus

with the aim of developing a stable MMRV that will stimulate immunity to VZV

similar to that seen after monovalent varicella vaccine.

ACKNOWLEDGMENTS TOP

We appreciate the assistance of Beverly Rich, Beth Arnold and Brockett

for performance of ELISA assays at Merck Research Laboratories and

Staehle for valuable input in manuscript preparation.

APPENDIX TOP

MMRV Study Group: Terry Cashmore, M.D., Lon Dubey, M.D., Louis Luevanos,

M.D., Ele Y. Ibarra-Pratt, R.N., A. Nelle, R.N., University of

California, San Diego, School of Medicine, La Jolla, CA; C. Jo White, M.D.,

Diane Stinson, M.B.A., Iksung Cho, M.S., Merck Research Laboratories, West

Point, PA; Dennis Clements, M.D., Ph.D., M.P.H., Emmanuel B. Walter, M.D.,

M.P.H., Duke University Medical Center, Duke Children's Hospital, Durham,

NC; Harry Keyserling, M.D., Caminade Padrick, R.N., M.P.H., Emory

University, School of Medicine, Atlanta, GA; Mark M. Blatter, M.D., S.

Reisinger, M.D., Pittsburgh Pediatric Research, Inc., Pittsburgh, PA; Dagna

Laufer, M.D., Barbara , M.D., University of Pennsylvania, School of

Medicine, Philadelphia, PA.

REFERENCES TOP

1. CA, Sepe SJ, Lin KF. The president's child immunization

initiative: a summary of the problem and the response. Public Health Rep

1993;108:419-25.

[Medline Link] [Context Link]

2. CA, WB, Mahanes JA, Sepe SJ. Progress on the childhood

immunization initiative. Public Health Rep. 1994;109:594-600.

[Medline Link] [Context Link]

3. Gershon AA, LaRussa P, Steinberg SP. Live attenuated varicella vaccine:

current status and future uses. Semin Pediatr Infect Dis 1991;2:171-7.

[Context Link]

4. Weibel RE, Neff BJ, Kuter BJ, et al. Live attenuated varicella vaccine:

efficacy trial in healthy children. N Engl J Med 1984;310:1409-15.

[Medline Link] [Context Link]

5. Kuter BJ, Weibel RE, Guess HA, et al. Oka/Merck varicella vaccine in

healthy children: final report of a 2-year efficacy study and 7-year

follow-up studies. Vaccine 1991;9:643-7.

[Medline Link] [CrossRef] [Context Link]

6. White CJ, Kuter BJ, Hildebrand CS, et al. Varicella vaccine (VARIVAX) in

healthy children and adolescents: results from clinical trials, 1987 to

1989. Pediatrics 1991;87:604-10.

[Medline Link] [Context Link]

7. Bernstein HH, Rothstein EP, BM, et al. Clinical survey of natural

varicella compared with breakthrough varicella after immunization with live

attenuated Oka/Merck varicella vaccine. Pediatrics 1993;92:833-7.

[Medline Link] [Context Link]

8. BM, Piercy SA, Plotkin SA, Starr SE. Modified chickenpox in

children immunized with the Oka/Merck varicella vaccine. Pediatrics

1993;91:17-22.

[Medline Link] [Context Link]

9. Takayama N, Kidokoro M, Suzuki K, Morita M. Immunization of healthy

children with measles-mumps-rubella trivalent vaccine simultaneously given

with varicella vaccine. Kansenshogaku Zasshi 1992;66:776-80.

[Medline Link] [Context Link]

10. PH, Saracen CL, G. Seroconversion rates to combined

measles-mumps-rubella-varicella vaccine of children with upper respiratory

tract infection. Pediatrics 1994;94:514-6.

[Medline Link] [Context Link]

11. BM, Laufer DS, Kuter BJ, Staehle B, White CJ. Safety and

immunogenicity of a combined live attenuated measles, mumps, rubella, and

varicella vaccine (MMRV) in healthy children. J Infect Dis 1996;173:731-4.

[Medline Link] [Context Link]

12. Mulholland EK, Ahonkhai VI, Greenwood AM, et al. Safety and

immunogenicity of Haemophilus influenzae type B-Neisseria meningitidis group

B outer membrane protein complex conjugate vaccine mixed in the syringe with

diphtheria-tetanus-pertussis vaccine in young Gambian infants. Pediatr

Infect Dis J 1993;12:632-7.

[Medline Link] [Context Link]

13. Shehab ZM, Brunell PA, Cobb E. Epidemiologic standardization of test for

susceptibility to mumps. J Infect Dis 1984;149:810-12.

[Context Link]

14. Wasmuth EH, WJ. A sensitive enzyme-linked immunosorbent assay

(ELISA) for antibody to varicella-zoster virus (VZV) using purified VZV

glycoprotein antigen. J Med Virol 1990;32:189-93.

[Medline Link] [Context Link]

15. Vella PP, Staub JM, Armstrong J, et al. Immunogenicity of a new

Haemophilus Influenzae type b conjugate vaccine (meningococcal protein

conjugate) (PedvaxHIB®). Pediatrics 1990;85(Suppl):668-75.

[Medline Link] [Context Link]

16. White CJ, Kuter BJ, Ngai A, et al. Modified cases of chickenpox after

varicella vaccination: coorelation of protection with antibody response.

Pediatr Infect Dis J 1992;11:19-23.

[Medline Link]

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Vaccine. 2002 Dec 13;21(3-4):281-9.

This tetravalent MMRV candidate vaccine showed promising results, although

further examination of the possible increase in minor fever and decreased

varicella immunogenicity should be assessed in future studies.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

2450703 & dopt=Abstract

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Pediatrics. 1986 Oct;78(4 Pt 2):742-7. Related Articles, Links

Combination measles, mumps, rubella and varicella vaccine.

Arbeter AM, Baker L, Starr SE, Levine BL, Books E, Plotkin SA.

Conclusion: Continued work is needed to select the appropriate dose of

varicella component, to assure higher persistence rate of varicella

antibody.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=3\

763291 & dopt=Abstract

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Wow, 16 years and they still haven't got it right...

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Application for Category 1 Continuing Medical Education and

PROGRAM EVALUATION

“Let’s Talk: Immunization Update”

November 19, 2002

Overall quality of the program:

Excellent

Poor

A. Content/information

5 4 3 2 1

B. Delivery of the program

5 4 3 2 1

C. Value to your practice

5 4 3 2 1

D. Length of the program

5 4 3 2 1

E. Ease of access/phone connection

5 4 3 2 1

The following objectives were identified for this program. How well did the

program

allow you to meet each objective?

At the conclusion of this activity, participants should be able to: (5=Very

well; 1=Poorly)

Describe the latest research on varicella vaccine safety and efficacy

5 4 3 2 1

Evaluate family reports of a history of varicella disease

5 4 3 2 1

Compare data on zoster transmission pre– and post-varicella vaccine

5 4 3 2 1

Describe vaccine trials related to varicella vaccine and shingles

5 4 3 2 1

Describe current MMRV trials

5 4 3 2 1

What is the single most important item you gained from this learning

experience?

Will you change your behavior or any of your office protocols because of

information

you got from this program? If yes, what changes will you make?

Suggested topics for future PA Chapter, AAP teleconferences.

#Page 2

The Pennsylvania Medical Society designates this continuing medical

education activity

for one hour of Category 1 of the Physician’s Recognition Award of the

American

Medical Association and the Pennsylvania Society Membership requirement.

Program participants are eligible to receive one hour of AMA Category 1

credit. To get

a CME certificate, complete this form and mail it to RiskCare, P.O Box 8742,

burg, PA 17105-8742 or fax it to RiskCare at 717-558-9804. If you have

any

questions, call 1-800-492-7898.

NAME: ____________________________________________________

MED. LICENSE #: _________________________

ADDRESS: __________________________________________________________

__________________________________________________________

City________________________ State ________ Zip ______________

TELEPHONE: ___________________________________

http://64.233.179.104/search?q=cache:s9ACaD4A0igJ:www.paaap.org/pdf/teleconf/111\

902/cme.pdf+MMRV+in+trials & hl=en

Came from,

http://www.paaap.org/

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*******

Safety, Tolerability, and Immunogenicity of an Investigational Vaccine with

Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age

Purpose

The purpose of this trial is to study the safety and immune response to

measles, mumps, and rubella in children who were vaccinated with an

investigational measles-mumps-rubella

live vaccine made with artificially made human protein.

Eligibility

Ages Eligible for Study: 12 Months - 18 Months, Genders Eligible for Study:

Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Healthy children 12 to 18 months of age

Exclusion Criteria:

History or prior exposure to measles, mumps, or rubella

History of allergic reactions to any component of the vaccines as evaluated

by the study doctor

More Information

Study ID Numbers: 2004_074

Record last reviewed: September 2004

Last Updated: October 25, 2004

Record first received: September 22, 2004

ClinicalTrials.gov Identifier: NCT00092404

Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on 2005-02-28

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