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Phase I prime-boost HIV vaccine trial planned

CHENNAI: The International AIDS Vaccine Initiative (IAVI), a New York based organisation, along with the ICMR and NACO, is planning to conduct Phase I HIV prime-boost vaccine trials in Chennai and Pune.

In a mail to this Correspondent in May this year, Dr. Seth Berkley, President and CEO of IAVI, New York had indicated a plan to start a prime-boost clinical trial in India.

Unlike the two HIV vaccine trials that were conducted at the National AIDS Research Institute (NARI), Pune, and the Tuberculosis Research Centre (TRC), Chennai, the trial now being planned will be a prime-boost vaccine.

Though the preliminary results of the Phase I MVA vaccine that had undergone trial at TRC are encouraging (The Hindu, January 24, 2008) and the final results are expected to become available very soon, there is currently no plan to take it to the Phase II trial stage. “It is not correct,” said Dr. Sonali Kochar, Medical Director of IVAI, New Delhi, that a phase II trial using MVA vaccine would be conducted on 300 volunteers.

Instead, the plan is to conduct a Phase I trial using ADVAX as a prime and MVA as a boost.

The prime-boost strategy is expected to improve the immune response and hence make the vaccine more efficacious.

There would be a control group which would be given a placebo and one arm that would be given only MVA and another both ADVAX and MVA.

The trial would happen simultaneously at NARI and the TRC.

The ADVAX is a DNA-based vaccine that contains a few HIV genes, while MVA is a vector that contains six HIV genes. Naked DNA requires no vector. The ADVAX has been tested in the United States.

The Genetic Engineering Approval Committee (GEAC) is expected to take up the issue of import of the MVA and ADVAX vaccine for trial at NARI in its August 13 meeting.

Permission to import a vaccine is taken up by the GEAC only when the Institutional Ethics Committee approves a trial.

According to reliable sources, the TRC has also got the Institutional Ethics Committee’s permission.

The GEAC has to approve the import of the vaccine and the Drugs Controller has to provide the necessary permission before the trial can start in India.

The MVA vaccine that has undergone Phase I trial at the TRC cannot cure HIV. And, like most HIV vaccines being tested across the world, the MVA vaccine cannot prevent HIV infection. It can only help reduce the chances of infecting others and stop the infected person from progressing to a disease state (AIDS).

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