A Phase III randomised, double-blind, placebo-controlled trial of 116E rotavirus vaccine undertaken in infants at three centres in India was found to be safe. It had modest efficacy of 56.4 per cent against severe rotavirus gastroenteritis during the first year of life. The results were published in The Lancet on Wednesday.
With about 75,000 to 1,22,000 deaths per year, India accounts for a quarter of rotavirus deaths in the world. Rotavirus diarrhoea accounts for almost 10 per cent of all under-five deaths and it is responsible for about 39 per cent of diarrhoea-related admissions in the country. About 70 per cent of admissions take place in the first year of life.
The Hyderabad-based Bharat Biotech International, which had undertaken the clinical development of the vaccine and would manufacture it, has committed to make the vaccine available at not more than $1 per dose for government procurement.
The trial took place between March 2011 and November 5, 2012 in Delhi (urban), Pune (rural) and Vellore (rural and urban). Three doses of the oral vaccine were given at ages 6-7 weeks, 10 weeks and 14 weeks respectively. Other childhood vaccines were given concurrently.
Over 4,500 infants received the oral vaccine, while over 2,250 received a placebo. But for the primary per-protocol efficacy analysis, only over 4,350 vaccinated infants and nearly 2,200 infants who received a placebo were included. Though 25 deaths were reported in the vaccine arm and 17 in the placebo group, the deaths were found to be unrelated to the vaccine, the paper notes.
“The vaccine is very close to getting licensed in India,” said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech International. “We have developed a dedicated manufacturing facility for rotavirus vaccine. It will be ready in 4-6 months.”
The vaccine was developed by the “combined expertise and interests” of investigators from 13 institutions.