Two phases of AIDS trial OK, now for last shot

Dr Sanjay Mehendale, principal investigator of the anti-AIDS vaccine trials, said, ‘‘They (review board) have analysed the preliminary data and allowed administering the final dose. Hence the process of screening another 10 volunteers is underway.’’

The first ever clinical trials on humans got underway in February at NARI and is currently testing vaccine candidate tgAAC09. This is modelled after HIV subtype C, the type that accounts for most infections worldwide and is prevalent in many developing countries, including India and South Africa.

The complete Phase I vaccine trial is the first stage of human testing whose primary purpose is to evaluate safety. The trial will take approximately one and-a-half years to complete and will enroll 30 volunteers, men and women, who are in all in good health and not HIV infected.

The India project is part of a multi-country Phase I trial of tgAAC09 that is also underway in Europe—researchers in Germany and Belgium are testing the vaccine candidate in partnership with International AIDS Vaccine Initiative (IAVI).

Pune’s NARI is the nodal agency for recruiting volunteers and conducting the trials. During clinical trials, medical scientists will test whether the vaccine has the potential to stimulate the production of immune cells that kill cells infected with HIV.

The trials will also determine the safety, immunogenicity (ability to induce strong immune responses in a person to fight HIV) of the intramuscular vaccine, preliminary dose requirement and schedules for immunisation.