Tests, which involve 48 adults, will be randomised and placebo-controlled
Bharat Biotech International Ltd in Hyderabad will start the Phase I clinical trial of Zika vaccine (MR 766) in two centres in India next month.
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“We have already got the approval from DCGI [Drug Controller General of India] in March to carry out the Phase I clinical trial,” says Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.
It will be a randomised, placebo-controlled, double-blind trial involving 48 adults, both men and women (who are not pregnant). Each volunteer will receive two zika vaccine doses on days 0 [the starting day] and 30 and will be followed-up for a year for both safety and immune response. Three different dose ranges will be tested.
There will be three arms in the trial, and each one will recieve one of the three different dose ranges.
The Phase I is being initiated based on the promising results in animals trials. In the animal trials, two doses of the vaccine made using an African Zika virus strain conferred 100% protection against mortality and disease in mice. The protection was the same when the mice were infected with an Asian and an African Zika strains.
While the viral load was “undetectable” in the case of vaccinated mice, the amount of virus in unvaccinated mice shot up four days after being infected. All the unvaccinated mice died eight days after infection by the African strain and 12 days after infection by the Asian strain.