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Serum Institute’s fast-acting rabies antibody in human trials

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Friday, October 9, 2009, 13:54 This news item was posted in Biotech category and has 1 Comment so far.

New antibody can neutralize rabies virus at infection sites in multiple bites

New drug which can instantly de-activate the deadly rabies virus immediately after the dog bite is currently being tested by India’s leading vaccine maker Serum Institute of India.

The new anti-rabies drug in the form of a humanized monoclonal antibody (mAB) is developed by and the University of Massachusetts

Serum’s new rabies antibody is currently being studied in a volunteer group comprising 84 people at the KEM hospital in Mumbai, reports said.

84 healthy volunteers will receive various doses of the new anti-rabies antibody to test the tolerability and biological activity.

Serum’s study in KEM Hospital will be mark the phase phase 1 study of the anti-rabies antibody in the country.

Serum’s new humanized antibody showed that it neutralised all isolates available from a panel of rabies viruses in the the pre-clinical testing, according to the researchers from the University of Massachusetts.

Serum’s new rabies antibody will help to neutralise the virus in cases where immediate transmission of infection is suspected. For example, in cases of bites at the nerve endings or in multiple bites the chances of rapid infection are very high.

“It takes 7-10 days for the antibodies to be formed after the vaccine is administered. The immediate administration of this new antibody would help in neutralising the rabies virus,” stated a senior official with serum.

Presently available rabies vaccine takes at least ten days to develop antibodies to circulate in the system.

Serum’s new anti-rabies antibody, however, is not a substitute for the existing rabies vaccination.

Rabies infection can be prevented to a great extend using a rabies vaccine and human rabies immune globulin (hRIG) soon after exposure.

But human rabies immune globulin which is derived from human blood, is often not available in  countries like India and is quite expensive.

Currently, horse-derived immune globulin serum is used in many parts of the world. But equine serums have several side effects side-effects.

Serum has chosen India for the first phase of human studies because of the wider prevalence of the rabie infection in the country. More than 50,000 people are bitten by dogs in India every year.

Serum institute, which claims to have developed the World’s first adsorbed liquid HDC rabies vaccine at an affordable price within the reach of the majority, has SII Rabivax in the markets.

SII Rabivax rabies vaccine U.S.P. (Adsorbed) s a single sterile, cell culture derived rabies vaccine for pre-and post-exposure prophylaxis in humans. It is prepared with Pitman-Moore strain of rabies virus. The virus is propagated on human diploid cells. The virus is inactivated with ß propiolactone. After inactivation the virus is adsorbed onto aluminum phosphate.

The Pune, Maharashtra-based serum institute also produces hundreds of millions of doses of the measles, mumps and rubella group of vaccines annually. Serum Institute meets 100 % requirements for measles vaccine of the Government of India and also the global requirements.

Serum’s manufacturing facilities conform to WHO current Good Manufacturing Practice (cGMP) requirements and are approved by WHO, Geneva. The unique large bioreactors for DTP group of vaccines have a huge batch size to produce millions of doses.

Serum Institute of India Ltd. has established it self as the world’s largest producer of measles and DTP group of vaccines. It is estimated that two out of every three children immunized in the world is vaccinated by a vaccine manufactured by Serum Institute. Serum’s products have been used in 140 countries across the globe.

Serum Institute of India was founded in 1966 to manufacture life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. Thereafter, several life-saving biologicals were manufactured at affordable prices.

Serum made India self-sufficient for tetanus anti-toxin and anti-snake venom serum, followed by DTP (Diphtheria, Tetanus and Pertussis) group of vaccines and then later on MMR (measles, mumps and rubella) group of vaccines.

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One Response to “Serum Institute’s fast-acting rabies antibody in human trials”

  1. p.srinivas yadav said on Tuesday, May 4, 2010, 13:12

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