Inhaled Vaccine for Anthrax articles

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http://www.biodefenseeducation.org/newsItems/departments/anthrax

Anthrax - Inhaled Anthrax Vaccine Protects in Animals

Reuters - A powdered anthrax vaccine that people potentially could take by

themselves protects rabbits against the deadliest form of the bacteria

www.cidrap.umn.edu/cidrap/content/ bt/anthrax/news/sep0104anthrax.html

Inhaled anthrax vaccine tested in animals

Sep 1, 2004 (CIDRAP News) – US Army and private researchers have developed

a powdered anthrax vaccine that looks promising in initial animal studies

and could eliminate the need for needle injections, according to the

American Chemical Society (ACS).

The vaccine, designed for nasal inhalation, may offer a faster and easier

way to protect both civilians and soldiers in case of an anthrax attack,

the ACS said in a news release. The vaccine was described Aug 25 at the

ACS's annual meeting in Philadelphia.

The standard anthrax vaccine, which is required for US military personnel

in high-risk regions, involves six injections over 18 months, followed by

annual boosters.

The powdered vaccine is a joint project of BD Technologies, Research

Triangle Park, N.C., and the US Army Medical Research Institute of

Infectious Diseases in Frederick, Md., the ACS reported. The vaccine uses a

recombinant form of anthrax protective antigen (rPA) and can be

self-administered with a disposable delivery device.

In laboratory tests, rabbits that were given the vaccine and then exposed

to a lethal dose of anthrax had survival rates of 83% to 100%, according to

the ACS. More animal studies are needed before the vaccine is tested in

humans, but human trials could start within 2 to 3 years.

Vince Sullivan, PhD, the lead investigator on the project, said, " Our

intranasal powder vaccine discovery may provide a highly effective, more

flexible, mobile and easy-to-use method of administering the anthrax

vaccine in clinical and field settings. " Sullivan is a chemist with BD

Technologies.

Initial data indicate that the powdered formulation of rPA is more stable

than the liquid version and can withstand a wider range of temperatures,

allowing it to be stockpiled for longer periods and in more extreme

conditions without refrigeration, the ACS said.

Researchers don't know yet how many doses or what size dose of the new

vaccine will be required, according to the release.

See also:

ACS news release on Eurekalert

http://www.eurekalert.org/pub_releases/2004-08/acs-av081604.php

Mar 12, 2004, CIDRAP News story, " HHS to buy up to 75 million doses of new

anthrax vaccine "

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http://www.sciencedaily.com/releases/2004/08/040826090304.htm

Date: 2004-08-30

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Needle-free Anthrax Vaccine Shows Promise In Animal Studies

PHILADELPHIA, Aug. 25 — Researchers have developed a powdered form of an

anthrax vaccine that could potentially be inhaled through the nose and

eliminate the need for needle injections. The new vaccine, which appears

promising in preliminary animal studies, may offer a faster and easier way

to protect the general population as well as soldiers on the battlefield in

the event of a deadly bioterror attack, the researchers say.

The development, a joint project of BD Technologies and the U.S. Army

Medical Research Institute of Infectious Disease, was described today at

the 228th national meeting of the American Chemical Society, the world's

largest scientific society.

The vaccine represents a growing pipeline of needle-free drug delivery

technologies that are being developed for consumers, such as the

FluMistTMintranasal vaccine currently sold to combat influenza. Considered

the next generation anthrax vaccine, the new formulation is based on an

anthrax recombinant protective antigen (rPA) and can be formulated as a dry

powder and self-administered through the nose using a novel, disposable

powder delivery device, the researchers say.

The standard delivery for anthrax vaccination is through subcutaneous and

intramuscular administration of a liquid formula using conventional needles

and syringes, but this method has several drawbacks when employed for mass

vaccination, including accidental needle-stick injury, the need for highly

trained healthcare professionals and painful injections, the scientists say.

" Our intranasal powder vaccine discovery may provide a highly effective,

more flexible, mobile and easy-to-use method of administering the anthrax

vaccine in clinical and field settings, " says the project's lead

investigator, Vince Sullivan, Ph.D., a chemist with BD Technologies'

Advanced Drug Delivery group in Research Triangle Park, N.C.

The vaccine has not yet been tested in humans, and additional animal

studies are needed, but clinical trials could be possible within the next

two to three years, investigators say.

In laboratory tests using rabbits exposed to a lethal dose of inhalation

anthrax, nasal immunization with the powder resulted in an 83 to 100

percent survival rate, similar to the protection offered by the injectable

formulation, according to a key researcher on the project, Ge Jiang, Ph.D.,

a pharmaceutical scientist with BD Technologies.

Initial data indicates that the powdered formulation of the rPA antigen, a

genetically engineered protein, is also more stable than the liquid version

and can withstand wider temperature extremes, allowing it to be stockpiled

for longer periods and in more extreme conditions without the need for

refrigeration, the researchers say.

Conventional anthrax vaccines, derived from Bacillus anthracis bacteria,

require six doses over the course of an 18-month period, with annual

booster injections recommended thereafter. It is not yet known how many

times and at what dose the new vaccine will need to be administered to

maintain protection, the researchers say, adding that this issue is being

investigated.

" This is not a cure for anthrax, but may be a better means of protecting

at-risk populations from infection, " Sullivan explains.

Anthrax vaccine administration is now mandatory for military personnel sent

to areas with high risk of exposure and recommended for other groups,

including some laboratory and postal workers.

Inhalation anthrax can be fatal if untreated. Doctors currently provide

antibiotics once infection has occurred, but treatment must be initiated

early to be effective. In addition to improving prevention methods,

researchers are continuing to try to develop better drugs to block the

deadly bacterium once a person has been exposed.

The American Chemical Society is a nonprofit organization, chartered by the

U.S. Congress, with a multidisciplinary membership of more than 159,000

chemists and chemical engineers. It publishes numerous scientific journals

and databases, convenes major research conferences and provides

educational, science policy and career programs in chemistry. Its main

offices are in Washington, D.C., and Columbus, Ohio.

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This story has been adapted from a news release issued by American Chemical

Society.

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Sheri Nakken, R.N., MA, Classical Homeopath

http://www.nccn.net/~wwithin/vaccine.htm