Hopes of an indigenous HIV vaccine fade

International body claims that the vaccine will not be stable

 However, sources close to the vaccine development alleged that the vaccine was 97 per cent stable way back in 2002 and the rest could have been worked out had the IAVI paid more attention to the indigenous vaccine. IAVI has refuted the charge point blank.

The vaccine based on the common Indian strain of HIV  was developed through a collaboration between Indian Council of Medical Research and National Institutes of Health USA. The vaccine was then manufactured by US company Therion Biologicals.

After successful animal studies in mice and rabbits, the vaccine was put through two rounds of phase-I clinical trails between 2006 and 2009. In the first trial, it was tried alone and second time in a prime-boost mode with another DNA vaccine.

Data available with Deccan Herald shows that in the first trial at Tuberculosis Research Centre in Chennai, “The vaccine (TBC-M4) appears to be very immunogenic (generating immune response against HIV) at both low and high doses. The magnitude of the response. Although modest, is persistent.” The vaccine was found safe for human use as well. Buoyed by the success, a second trial was planned at the TRC and National AIDS Research Institute, Pune, with ADVAX-DNA as the prime vaccine and TBC-M4 as booster.

Two groups of 12 volunteers each were shot with the two vaccines. It was found HIV-specific response was 4-8 times higher in those who received both prime vaccine and the booster dose rather than those who were inoculated with the Indian vaccine alone. The trial results will be announced in an AIDS conference in Bangkok on September 14.
Despite positive results, IAVI decided not to take the vaccine to the next phase because of the vaccine’s instability in large scale production.

“The vector (MVA) was identified as genetically unstable, suggesting that it would be difficult to predict batch-to-batch consistency of the vaccine for efficacy studies and for commercial manufacturing with this vector (MVA),” said Rajat Goyal, IAVI country director.

“Stability issues were not observed in that trial. It is possible that seed stocks at the company had some problems, which was noticed later. Stability problems were seen in vaccines licensed for human use also.