Phase 3 Of Hiv Trials

[cdnvic]

Phase 3 of HIV trials

Published on December 23, 2005

Registration of volunteers for the third phase of human trials of an HIV-Aids vaccine has been completed after kicking off on September 26, 2003, a senior public-health official said yesterday.

Doctor Suphachi Ruek-ngarm said the third phase would involve the largest group of people – 16,253 selected from 65,000 volunteers.

“It will take three years to monitor the results and, if successful, Thailand will have rights to the drug at a special price. We will give priority to Chon Buri and Rayong patients first – the provinces where the 16,253 volunteers live,” he said.

The vaccine being tested is to prevent infection by the HIV virus types “B” and “E”, which is spreading in Thailand, and is a combination of two kinds of vaccine – ALVAC and AIDS Vac.

The Nation

[Prakanong2005]

Well in general clinical trial parlance phase 3 is where the trial has been tried in intensive care conditions and now its being trialled in the environment where is would be used in practice.

Vaccines trials have their own special peculiarities though as well. If it was phase 3 we would be expecting it to be filed for regulatory approval in the next couple of years - similar to the Cervical Cancer vaccines now.

Here is one for different sub-types

"Targeted Genetics Corporation and The International AIDS Vaccine Initiative (IAVI) today announced the start of a Phase II trial in South Africa to test the safety and immunogenicity of tgAAC09, a preventive HIV vaccine candidate that is based on HIV subtype C, the subtype of the virus most prevalent in southern and eastern Africa. This is the first Phase II HIV vaccine trial to be held in South Africa. Candidate vaccines that are proven to be safe in Phase I trials move on to Phase II trials, allowing investigators to test the immune response and acquire more data on safety."

The last I read about a HIV vaccine scientists were talking about a 15-20 lead time to market for a prophylactic vaccine - it may be different for therapeutic.

I work at the largest vaccine site in the world in Data Management )in Clinical Trials)

We are working on a vaccine for HIV obviously and have joint ventures with the likes of Pasteur funded by the EU.

[Prakanong2005]

Here is another one with relation to therapeutic vaccines which are aid to be the next big thing in vaccines - they are working on them for different cancers such as specific breast cancers

"Drugmaker Wyeth on Thursday said it won a $32 million, five-year contract with the U.S. government to develop therapeutic HIV vaccines in conjunction with outside researchers. The National Institutes of Health will provide the funding for direct costs associated with the design, manufacture and release of the clinical trial materials, the company said. Wyeth will contribute at least $23 million worth of in-kind services. The NIH had previously awarded Wyeth two five-year contracts to evaluate two separate preventative HIV vaccine strategies"

Wyeth have also just hired one of *The* top guys in HIV Vaccine research