Pune AIDS researchers have a New Year plan: human trial of vaccine

According to Dr Sanjay Mehendale, Deputy Director (Senior Grade), NARI, and principal investigator of the trial, ‘‘all necessary ethical and regulatory approvals have been taken and the process of selecting 30 volunteers is underway.’’

Phase I of the Rs 1.4-crore trial will be conducted on healthy individuals who are not infected with HIV, he said. ‘‘Contrary to fears, the AIDS vaccine will not be tested by vaccinating people and then deliberately exposing them to HIV,’’ said Mehendale.

The series of trials, to be conducted at NARI’s Vaccine Trial Clinic and Laboratory, will primarily test the safety and immunogenicity of the vaccine, he said. It will check whether the vaccine causes side-effects and how the human immune system responds to it.

The 30 volunteers, Mehendale said, are being selected from a pool of blood donors, health care workers, students and social workers.

‘‘NARI has conducted research studies to assess individual perceptions of risks and benefits related to trial participation,’’ said Mehendale, adding that an intra-muscular injection of 0.5 ml will be given at three dosage levels during Phase I.

Approvals have been obtained from the Drug Controller, Genetic Engineering Committee and other scientific bodies, he said. This was after the National AIDS Control Organisation and Indian Council of Medical Research signed an MoU with the International AIDS Vaccine Initiative, in December 2000, for developing the AAV vaccine.

A non-pathogenic virus, AAV is a vehicle for HIV-I genes and the vaccine is being manufactured by Targeted Genetics Corporation, Seattle. According to Mehendale, pre-clinical studies on animals in the US have established its safety and immunogenicity.

‘‘After 22 years, HIV/AIDS remains an emergency demanding a holistic response,’’ said Mehendale. India alone has 5.1 million HIV positive cases, second-highest in the world after South Africa. Currently, trials of 30 such vaccines are being conducted across 19 countries in six continents.

One of them, AIDSVAX, completed Phase III trials in North America and Europe, but finally failed to demonstrate effective protection against HIV. Another vaccine is being efficacy-tested in Thailand, though results will not be out before 2008.