Phase I clinical trial of Zika vaccine to begin next month

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 virus

vaccine (MR 766) in two centres in India next month.

“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.

Dose ranges

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 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.

Source : The Hindu