"The indications so far are that it is safe"
CHENNAI: With the first phase of the AIDS vaccine human trial being kicked off in the city, scientists involved in the trial are looking at absorbing more volunteers for the second such vaccine trial in the country.
The process of fulfilling the requirement of selecting two groups of 16 volunteers each is on, P.R. Narayanan, Director, Tuberculosis Research Centre, an Indian Council of Medical Reaserch body conducting the vaccine trial in Chennai, said on Tuesday.
TRC collaborates with YRG Care and the International AIDS Vaccine Initiative on the project, conservatively estimated to cost at least one million USD.
While some of the volunteers have been administered two (low) doses of the Modified Vaccine Ankara (MVA), at least 16 more will have to volunteer to join the study. None of the volunteers who have received the vaccine has shown any side effects so far, Dr. Narayanan said.
Ideally, volunteers should be in the age group 18 to 50 years, healthy, uninfected by the HIV virus and at `low risk' for HIV infection. They will receive three injections, at the beginning, one month and six months later. In 18 months, the period of the first phase, each volunteer will have to visit the centre 17 times and blood will be drawn from him/her 14 times, Dr. Narayanan explained.
All volunteers will have to pass a test of understanding, based on the information provided to them about the trial, apart from satisfying medical criteria.
Mostly, volunteers are recruited through advocacy meets and sensitisation sessions, individual contacts also yield some participants.
It is only after a three-level screening process inclusive of a risk assessment that a volunteer can be recruited.
So far, 16 volunteers have been enrolled. The safety data from this group will be reviewed by an international safety review board and when it grants clearance, 16 additional volunteers will be enrolled to receive a higher dose of the vaccine candidate.
Allaying fears that volunteers might contract HIV when injected with the vaccine, Sunithi Solomon, director, YRG Care, one of the participants in the trial involving the International AIDS Vaccine Initiative, said the vaccine contains only a few genetic components and not the whole virus. "No person will get HIV through the vaccine.
In addition, following ethical norms set for human trials, the identity of the volunteer will be kept confidential," Dr. Solomon explained.
Further elaborating on this, V.Ramanathan, principal investigator of the trial, said there will be no pressure on the volunteers to participate or continue in the trial.
Volunteers who have problems can also seek the counsel of the independently constituted arbitration board.
"Of course, any volunteer can feel free to walk out of the trial at any point of time."
Each volunteer will be paid Rs.500 per visit as compensation for man hours lost, any vaccine-related side effects will be taken care of and he/she will be provided medical insurance for the period of the trial for any vaccine unrelated events, according to a decision taken by the Union Ministry of Health, Dr.Ramanathan said.
Jean Louis Excler, Senior Director, Medical Affairs, IAVI India, said the first phase of the vaccine trial being conducted at National AIDS Research Institute, Pune, would come to an end this year and the indications so far are that the vaccine is safe.