NARI's trials of AIDS vaccine deferred

[Guest guest]

Human trials of AIDS vaccine deferred

SIDDHARTHA D. KASHYAP. TIMES NEWS NETWORK [THURSDAY, MAY 20, 2004

05:52:52 PM]

PUNE: The much-hyped clinical trials on humans for the Aids vaccine

has been deferred, as scientists working on the ambitious project

have not achieved the expected results from the pre-clinical trials.

The modified vaccinia ankara (MVA) vaccine, developed at the National

AIDS Research Institute (Nari) laboratory at Pune, is a vector

(carrier) used for expressing HIV antigens. (An antigen is a foreign

substance which induces a human response in the body, esp. the

production of antibodies).

While officials at Nari and its parent body — Indian council of

medical research (ICMR) — are totally tight-lipped about the

developments, a senior official from the International AIDS Vaccine

Initiative (IAVI), confirmed that the human trials are not happening

immediately, as planned earlier during the first quarter of 2004.

Ramesh Paranjape, officer-in-charge of Nari had earlier said the new

vaccine was likely to undergo its first human trials in the first

quarter of this year, after the mandatory pre-clinical and toxicity

studies. Both the director-general of ICMR, Dr NK Ganguly and

Paranjape were unavailable for comments.

Iavi is currently working in close tandem with the government of

India to develop the vaccine for the specific subtype C strain,

appropriate for use in India. While Nari is working with the US-based

biotech firm Therion Biologics, Iavi's role is to facilitate easy

exchange of ideas of all earlier initiatives and current efforts

taken elsewhere.

Director (medical affairs) Dr Jean-Louis Excler, when contacted, only

said the working group is hopeful that a desired outcome is met soon

to carry the initiative further. " Moreover, the national ethics

committee also has to give its approval before the conduct of the

trials on 30 healthy volunteers, " he said.

While admitting of " certain hiccups " in the process of the pre-

clinical trials, Dr Excler only said giddy optimism should not come

in the way of vaccine development. " Prior experiences indicate that

all is not that easy as it seems, he said.

When contacted, deputy director at Nari, Dr Sanjay Mehendale, only

said the vaccine is presently undergoing the trials on the second

group of animals. " We first tested the vaccine on mice, and are now

doing it on rabbits, " he said, adding that it is difficult to tell as

to how long it would take for the human trials. " It may happen in

another three-four months or may even extend till next year, " he

added.

The phase-I trials are important to access the safety and

immunogenicity (ability to induce strong and measurable immune

responses to be able to fight against HIV) of the vaccine, and the

subsequent trials are based on its results before the vaccine can be

used as a clinical product.

http://timesofindia.indiatimes.com/cms.dll/html/uncomp/articleshow?

msid=687810