Unethical AIDS vaccine trial in India

[Guest guest]

Despite note that AIDS vaccine had failed, India changed rules and

continued trials

Pallava Bagla. December 23, 2007

Barely 14 days into trials in Pune in Feb 2005, tests in Germany,

Belgium said vaccine ineffective; asked why India then allowed

trials, director of lab says `scientists learnt a lot'

New Delhi, December 22:The first-ever AIDS vaccine trial in India,

flagged off by Union Health Minister Anbumani Ramadoss and Union

Science and Technology Minister Kapil Sibal two years ago, ended in

failure when it was announced in Pune last month that although it

was " well tolerated, " it did not " elicit the acceptable immune

response. "

The announcement overlooked one glaring fact: the trial, conducted on

30 healthy volunteers at Pune's National AIDS Research Institute

(NARI), continued for a whole year although it was known within the

first fortnight that the same vaccine had failed in tests in Germany

and Belgium — with exactly the same conclusions.

And yet the Government amended its policy to accommodate the trial.

But more of that later.

The trial, a tripartite venture of the Indian Council of Medical

Research (ICMR), the International AIDS Vaccine Initiative (IAVI),

and the National AIDS Control Organization (NACO), began on February

7, 2005 at NARI. India was one of the three countries chosen for

this " multi-country trial. "

When contacted by The Sunday Express, NARI director Ramesh Paranjape

said: " The Pune trial ended safely and the health of volunteers has

not been compromised at all. " Asked why the trial continued for one

year when it was known that the vaccine had failed, he

said: " Scientists learnt a lot in how to conduct and manage trials

for an AIDS vaccine. " Officially, informed consent and necessary

ethical clearances were accorded to the trial.

The IAVI spokesman declined to comment.

" There was no justification for the trial, " said Pushp M Bhargava,

founder-director of the Centre for Cellular and Molecular Biology,

Hyderabad, and a member of IAVI's board. " It was unethical and

totally uncalled for. The volunteers can't be treated like guinea

pigs, they should have been told that he vaccine being tested on them

had failed. We were not shown the data from Germany and Belgium —

till date that has not been shared with us. "

This is surprising.

The vaccine tested was a biotechnologically tamed version of the

living Adeno Associated Virus (AAV) scientifically named tgAAC09. It

was sourced by India through the New York-based IAVI from a US

pharmaceutical company Targeted Genetics.

On February 22, 2005 — 14 days into the trial in India — Targeted

Genetics issued an official note on its European trial saying

that " the vaccine [AAV — tgAAC09] at the doses evaluated in this

initial study did not elicit significant immune responses. " In

layman's terms, the vaccine had failed in Europe even though it had

been tested on 50 individuals in a Phase-I trial meant to evaluate

safety.

Ironically, to accommodate the trial, India departed from its

established regulatory procedure. Until this genetically engineered

AIDS vaccine was tested in 2005, the policy was that a " phase lag "

had to be maintained before any clinical trial of a foreign-made

molecule. In other words, a molecule or a vaccine developed in a

foreign country could never be tested in India for a Phase-I trial

until the host country where the molecule was invented had not

undertaken a full fledged Phase-II trial.

But this trial went ahead on the grounds that there was a health

emergency and the need was to arrest the galloping epidemic of AIDS.

Given the confidentiality clause of the trial, no independent

verification has been possible on how the Indian volunteers fared

physically and/or psychologically in the Pune trial.

http://www.indianexpress.com/sunday/story/253329.html