India hopeful of AIDS vaccine by 2010
 New Delhi - July 23, 2004

India hopes to begin the first phase of human clinical trial of an AIDS vaccine by yearend even as work is progressing rapidly on another vaccine prior to beginning clinical trials.

Scientists associated with both the vaccines under development are hopeful of a breakthrough and an answer to prevent HIV infection and AIDS by the end of the decade, despite setbacks and delays faced in animal clinical trial stage due to protests by activists.

Worldwide over 30 vaccine candidates are in human clinical trials in 19 countries, according to the International AIDS Vaccine Initiative (IAVI), which is supporting research in India among other countries.

Since 2001, IAVI has been partnering the National AIDS Control Organization (NACO) and Indian Council for Medical Research (ICMR) for developing a vaccine to counter subtype C, the strain of HIV prevalent in India.

There are currently an estimated 43 million people with HIV/AIDS in the world, with five million new cases being added every year. India, with 5.1 million HIV/AIDS cases, has the second high incidence of the disease in the world after South Africa.

"We are happy with the progress and the results creeping in. After getting regulatory clearances from the Drug Controller General of India, by end of 2004 we hope to enter the human clinical trial phase," ICMR director N.K. Ganguly told IANS.

Another vaccine HIV-1 DNA being developed by National HIV Reference Centre at the Institute of Medical Sciences (AIIMS) under the leadership of Pradeep Seth, head of the microbiology department, is ready to enter the toxicology test prior to human clinical trial.

It is another matter that before testing the effect of the vaccine on other human beings, Seth decided to test its efficacy on himself.

"We will prepare for the human clinical trials after doing mandatory toxicity testing. We have given our vaccine for production of certified prototype as required. We should get it by August first week and begin the toxicology test," Seth told IANS.

The process of conducting and preparing the report would take around nine months to one year after which Seth hopes to begin clinical trials by middle of next year.

On his decision to test the vaccine for HIV subtype C, Seth said, "I just wanted to be sure of its efficacy and the results on myself have been encouraging. If all goes well, by the end of this decade we hope to have the vaccine ready for use."

According to Ganguly the vaccine being developed by ICMR has two constructors. One is modified vaccinia Ankara (MVA) vector packaged with six general HIV genes, while the other is adeno-associate virus (AAV) designed with subtype C HIV strain.

The AAV vector has been used in human gene therapy.

"We have completed the stability and toxicology test for AAV after preparation of the prototype. Once we get the regulatory clearance we will begin recruitment of volunteers for phase one of the human clinical trial at Pune, where the trial site has been prepared," said Ganguly.

For the MVA, the clinical trials are expected to start in 2005 after the toxicology test and getting clearance.

The four-phase clinical trials are expected to take around four years, Ganguly estimates as the Drug Controller has to give clearance on the basis of data collected after every stage.

Ahead of starting clinical trials, ICMR is preparing protocol for seeking informed consent of people willing to participate in the trials, a senior official said.

"So far there is no effective vaccine against HIV. All trials and results will show the level of protection the vaccines will offer. The vaccines would also help to reduce the treatment burden of antiretroviral drugs," said a senior official of the Department of Biotechnology, which is helping fund a number of vaccine research.

Keeping the fingers crossed, the scientific community is not willing to hazard a guess about the ultimate results of the two vaccines nearing human clinical trials and a breakthrough till the close of all phases of clinical trials.

Indo-Asian News Service