Bangkok Post - December 28, 2000
Nusara Thaitawat

The decision was made at a meeting of Thailand's top experts in HIV vaccine development on Monday, chaired by Mr Korn, even after a published study by Harvard University researchers done between 1996-2000 among more than 2,500 subjects concluded that the same vaccine failed to increase HIV progression free survival in the subjects.

Thailand's own sub-committee on vaccine evaluation had since August 1999 convened regularly to discuss the results of the Thai trial which showed no significant improvement between the volunteers taking the vaccine and those on a placebo. The sub-committee had also asked the researchers, led by Vina Churdboonchart, to redesign their proposed protocol to continue research on some 10,000 volunteers after it was found that it did not abide by universally accepted scientific guidelines for human trials, sub-committee members said.

All but one of its members have signed a draft motion "to suspend" Ms Vina's proposed protocol pending amendment as the debate over the results of the first trial and the need for redesign of the protocol has been going on for over a year without progress.

The decision to draft the motion was taken at the latest meeting of the sub-committee on Dec 21.

The issues include Ms Vina's status in the company which manufactures the vaccine, known commercially as Remune, developed by the California-based Immune Response Corp, which is seen as prejudicial in her work as the principal investigator of the trial.

There was the question about the use of moving on to a large-scale trial with some 10,000 volunteers while the Phase II trial involving some 300 volunteers, aimed at assessing the body's immune response to HIV, did not show any significant positive results.

"We have stated this point again and again but the researchers continue to insist that it is a matter of statistical methodology. How can we allow the research to proceed involving 10,000 lives while the Phase II remains inconclusive?" they said. In addition, the protocol proposes "an open-label" approach which means all involved in the trial will know who is being administered the vaccine or placebo, which is open to bias. Other experts say this approach is normally used only in the early stages of research.

Usually in large-scale trials, the "double-blind placebo-controlled"approach is used, this means that neither the volunteers nor the researchers know who is on the vaccine or placebo. At the end of the trial, a comparison can be made between the two groups of volunteers to assess the vaccine's efficacy.

Another issue is data management which the sub-committee members agree did not follow internationally accepted standards of excellence in scientific research.

Mr Korn assigned the director-general of the ministry's Medical Sciences Department, who by title also chairs the National Ethical Committee, to convene a meeting of all concerned to settle the scientific questions of the trial and whether or not to proceed with Ms Vina's proposed protocol.

The meeting is expected to be convened early next year.
001228
BP001206

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .