Death of US patient casts a shadow over AIDS vaccine trial in India

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Death of US patient casts a shadow over AIDS vaccine

From Kalyan Ray, DH News Service, New Delhi:

Death of an arthritis patient in the USA in a clinical trial is now

worrying scientists involved with India's first AIDS vaccine trial.

Both trials have a common element – use of adeno-associated viral

(AAV) vectors for carrying the drug.

At the National AIDS Research Institute (NARI) in Pune, scientists

injected 30 healthy volunteers with an AAV-based AIDS vaccine almost

one and half years ago during the first phase of India's maiden AIDS

vaccine trial.

In the USA, for the last few years, effectiveness of an AAV-based

gene therapy for treating inflammatory arthritis was being

investigated.

A Seattle-based company, Targeted Genetics Corporation, is the

pioneer of both AIDS vaccine and pioneer of the investigational gene

therapy. On July 24, the US Federal Food and Drug Administration

(FDA) halted the US trial, following the death of a patient who

received the therapy. Though the exact cause is still unknown, AAV is

a key suspect.

NARI Meeting

NARI is in the process of convening a meeting of the institute's

ethics committee within few days to find out how to convey the " news "

to the volunteers who were injected with the AAV-based AI9DS vaccine

to determine the safety of the vaccine.

" All our volunteers are healthy at the moment. We are observing them

for the last one year and will continue to do so for next four years.

As this report has now come to the light, we will go by the advice of

our ethics committee, " NARI Director Dr Ramesh Paranjape told Deccan

Herald.

According to the FDA, the gene therapy used AAV to deliver a gene

that could inhibit inflammation. As many as 100 people have been

enrolled in the trial and this is the only death. The illness was

related to receipt of a second injection of the product. " The

investigation into the cause of the patient's illness and subsequent

death is intensive, " FDA says.

National AIDS Control Organisation (NACO) Chief Ms K Sujatha Rao said

that she could not comment on the subject as she had not seen the

report.

The suspicion centred on AAV because of a new research by the

Washington University School of Medicine in St Louis published in the

latest issue of the journal Science, in which the scientists showed a

linkage between AAV and growth of tumour in mice.

The study raises safety concerns about the use of AAV vectors in

patients receiving experimental gene therapy.

http://www.deccanherald.com/Content/Jul292007/national2007072915854.as

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