26 March 2011
By Kounteya Sinha
New Delhi, India
The final phase–III "confirmatory" multi–centre clinical trial on 6,800 children, who are six weeks old, started last week at Society for Applied Studies in the capital. Around 200 children were administered three drops of "Rotavac", who are aged six, 10 and 14 weeks, respectively.
The other two centres – KEM hospital (Pune) and Christian Medical College (Vellore) – will start their trials in another two weeks. All children – 1,500 each in Pune and Vellore and another 3,800 in Delhi – will be observed for more than two years to see the vaccine’s efficacy against severe diarrhoea. The phase–II trials showed 90% protection, or "immunogenecity rate".
This live attenuated oral vaccine based on the rotavirus strain 116E, which was discovered by the present secretary of the department of biotechnology (DBT) Dr M K Bhan in the 1980s, is being developed by Bharat Biotech International Limited, Hyderabad. Both DBT and Bill and Melinda Gates Foundation are funding the project. Bill Gates told TOI, "We are funding phase–III trials of the rotavirus vaccine with around $30 million."
Dr Khan added, "DBT is funding nearly Rs 20 crore for the study. This will be a model for ethical trials in India. We have provided full insurance for family of those in the trial, and are also covering entire hospital treatment costs if need be."
Dr Nita Bhandari, chief coordinator of the trial from Society for Applied Studies, said the virus was discovered in 1982 under DBT’s Indo–US Vaccine Action Programme. All India Institute of Medical Sciences, Centre for Disease Control and Prevention, Indian Institute of Sciences, Stanford University and National Institute of Immunology in New Delhi were all part of the vaccine’s development over the last decade.
"The vaccine is similar to the oral polio drop. It will be given under the same regimen. There are two vaccines against the rotavirus in the market, but both are dev–eloped by Western companies. This will be the first vaccine developed by Indian res–earchers, and manufactured by an Indian vaccine firm," Dr Bhandari added.