ICMR asks NARI to explain questionable AIDS vaccine trial

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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.

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http://www.indianexpress.com/story/254028.html