Trials of AIDS vaccine to start in India

[Guest guest]

Trials of AIDS vaccine to start in India

Sanjay Kumar, BMJ 2003;326 952 (3 May)

India is getting ready for the first trials of an AIDS vaccine. Phase I trials

will begin later this year or early next year at the National AIDS Research

Institute in Pune, Maharashtra.

The International AIDS Vaccine Initiative has been working closely with the

Indian Council of Medical Research and the National AIDS Control Organisation

since December 2000 to develop and evaluate AIDS vaccines in India.

To reduce fears that Indians will be used as guinea pigs for the trial of an

AIDS vaccine that will be used only in the Western world, the initiative has

been trying to forge collaborations with the government, non-governmental

organisations, and policy makers at national and state levels.

A vaccine is projected as the last hope for the control of AIDS in India, which

has some four million people who are HIV positive, the second largest

concentration in one country after South Africa.

The first candidate vaccine to be tested in India will be modified vaccinia

Ankara, a live attenuated vaccine that will target HIV-1 subtype C. " This

subtype is predominant in India, accounting for nearly 91% of cases, " said Dr

Jean-Louis Excler, medical director of the initiative in India.

The other subtypes found mostly in northeastern India, albeit in smaller

numbers, include subtypes A, B, and E and a recombinant subtype AC, he added.

" There is, however, no really good epidemiological study of distribution of the

various HIV subtypes in India, " cautioned Dr Excler.

The vaccine is currently being developed by Therion Biologics, a company based

in Boston, Massachusetts. Talks are taking place with some Indian companies for

the manufacture of the vaccine in India when the phase I trials end, said Ms

Anjali Nayyar, the International AIDS Vaccine Initiative’s country director for

India. " We have at least two other candidate vaccines also in mind for testing

in India, but a decision on that will be taken after later consultation with

scientists, " she said.

" Toxicology data will be submitted to the drugs controller of India by October

this year, and we hope to get his permission for clinical trials soon

thereafter, " said Ms Nayyar.

In the first phase of clinical trials, which will last about a year, the vaccine

will be tested on 39 HIV negative people at low risk of infection from the Pune

area in western India. " We will ensure that informed consent is followed

strictly and the trials are cleared by the institutional ethics committee, " she

added. The issue of monetary incentives could be looked into more seriously

after the phase I trials are over, added Ms Nayyar.

" The vaccine is very safe, " she assured, " and there is no possibility of

volunteers getting infected through the vaccine. " However, there could be minor

side effects, which could be treated routinely, she added.

http://bmj.com/cgi/collection/AIDS