RSV - Synagis Package insert & more info on Synagis & vaccines in development

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Another drug or vaccine for a vaccine-induced illness

Sheri

http://www.medimmune.com/pdf/products/synagis_pi.pdf

SYNAGIS® (PALIVIZUMAB) Rx only

for Intramuscular Administration

DESCRIPTION: Synagis (palivizumab) is a humanized

monoclonal antibody (IgG1k) produced by

recombinant DNA technology, directed to an

epitope in the A antigenic site of the F protein of respiratory

syncytial virus (RSV). Synagis is a composite of

human (95%) and murine (5%) antibody sequences. The

human heavy chain sequence was derived from the

constant domains of human IgG1 and the variable framework

regions of the VH genes Cor (1) and Cess (2). The

human light chain sequence was derived from the constant

domain of Ck and the variable framework regions

of the VL gene K104 with Jk-4 (3). The murine sequences

were derived from a murine monoclonal antibody,

Mab 1129 (4), in a process that involved the grafting of the

murine complementarity determining regions into

the human antibody frameworks. Synagis is composed of two

heavy chains and two light chains and has a

molecular weight of approximately 148,000 Daltons.

Synagis is supplied as a sterile,

preservative-free liquid solution at 100 mg/mL to be administered by

intramuscular injection (IM). Thimerosal or other

mercury containing salts are not used in the production of

Synagis. The solution has a pH of 6.0 and should

appear clear or slightly opalescent.

Each 100 mg single-dose vial of Synagis liquid

solution contains 100 mg of Synagis, 3.9 mg of histidine,

0.1 mg of glycine, and 0.5 mg of chloride in a volume of 1 mL.

Each 50 mg single-dose vial of Synagis liquid

solution contains 50 mg of Synagis, 1.9 mg of histidine,

0.06 mg of glycine, and 0.2 mg of chloride in a volume of 0.5 mL

and yes, they refer to it as a vaccine here

http://www.vaccineinfo.net/immunization/vaccine/rsv/index.shtml

but it really isn't, but they call lots of things vaccines now

They are working on a 'vaccine'

http://www.mc.vanderbilt.edu/reporter/index.html?ID=4534

Researchers closing in on a RSV vaccine

February 17, 2006

http://www.immunizationinfo.org/vaccine_development_detail.cfv?id=100

Vaccines In Development

Respiratory Syncytial Virus

http://www.pharmaceutical-business-review.com/article_feature.asp?guid=5F3CAC50-\

07D5-461F-9117-E27D0F906AE6

RSV: lack of vaccine puts most vulnerable at risk

18th April 2007

By PBR Staff Writer

An infection with the respiratory syncytial virus

can result in hospitalization and sometimes

respiratory failure. With no suitable treatment

available and the only preventative medication

considered too expensive to be widely prescribed,

the need for an effective vaccine is high.

However, given the failure of recent

developmental efforts the launch of a successful

vaccine is still some time away.

http://www.who.int/vaccine_research/diseases/ari/en/index3.html

Respiratory syncytial virus (RSV)

" Vaccine

Development of vaccines to prevent RSV infection

have been complicated by the fact that host

immune responses appear to play a role in the

pathogenesis of the disease. Early studies in the

1960s showed that children vaccinated with a

formalin-inactivated RSV vaccine suffered from

more severe disease on subsequent exposure to the

virus as compared to unvaccinated controls. These

early trials resulted in the hospitalization of

80% of vaccinees and two deaths. "

http://www.upi.com/Health_Business/Briefing/2007/07/03/medimmune_testing_rsv_vac\

cine_in_kids/7382/

MedImmune testing RSV vaccine in kids

Published: July. 3, 2007 at 3:12 PM

GAITHERSBURG, Md., July. 3 (UPI) -- U.S. firm

MedImmune said Tuesday it has begun dosing

studies of its potential vaccine to prevent two

common children's respiratory infections.

The company said it has enrolled children aged

six months to 24 months in the phase 1 study to

assess the appropriate dose of its vaccine

designed to help prevent respiratory syncytial

virus (RSV) and parainfluenza virus type 3 infections (PIV-3).