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.