Human trials of AIDS vaccine begins

[Guest guest]

Human trials of AIDS vaccine begins

Special Correspondent

" 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.

Fears allayed

Allaying fears that volunteers might contract HIV when injected with

the vaccine, Sunithi , 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.

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.

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.

Wednesday, Jun 28, 2006

http://www.hindu.com/2006/06/28/stories/2006062819890600.htm