Failed Hiv Vaccine Tested?shocking News..

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ICMR asks national AIDS lab to explain questionable vaccine trial

Posted online: Tuesday, December 25, 2007

Test After Vaccine Failed: Jayanthi Natarajan, who joined IAVI as
country head long after the trial started, says she is resigning

Pallava Bagla & Teena Thacker

New Delhi, December 24: Two days after The Sunday Express reported
how the country's first-ever AIDS vaccine trial went for a full year
although it was known — within a fortnight of the trial starting —
that it had failed in Europe, the Indian Council of Medical Research,
one of the three institutions involved, has sought a written
explanation from the National AIDS Research Institute, Pune.

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

This is the institute where the trial was conducted on 30 healthy
volunteers.

In a related development, Jayanthi Natarajan, the country director in
India of the International AIDS Vaccine Initiative (IAVI), the
sponsor of the trial, has resigned. A former MP and Congress
spokesperson, she took charge of IAVI in May 2006, more than a year
after the trial had started in February 2005.

When contacted, she told The Indian Express today: "I am not dealing
with this, the trial started when I was not there. I am resigning."
Calling it a "serious issue," Sujit K. Bhattacharya, acting Director
General of ICMR, told The Indian Express that he had sought
an "urgent report" from Dr Ramesh Paranjape, NARI director. "You
cannot conduct clinical trials merely for academic reasons," said
Bhattacharya adding that NARI is a publicly funded institute and it
is wrong that they took money from foreign donors to conduct a
clinical trial.

The Pune trial conducted on 30 healthy volunteers 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.

The trial was initiated as a result of a tripartite venture of ICMR,
the International AIDS Vaccine Initiative (IAVI), and NACO and began
on February 7, 2005. India was one of the three countries chosen for
this "multi-country trial." To accommodate this trial, India amended
its long-standing regulatory procedures. According to NARI, the trial
ended safely and volunteers' health "had not been compromised."

Paranjape told this newspaper that the trial helped scientists learn
conducting and managing trials for an AIDS vaccine.

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.

editor@expressindia.com