Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
Bangkok Post - September 18, 2007
The article states: "The final phase of an Aids vaccine trial in Thailand will be extended for another two years..." Actually, the Phase III HIV vaccine trial is not being "extended"; rather, the trial is scheduled to end in the summer of 2009 as planned.
At its July 18-19 meeting, the Data and Safety Monitoring Board (DSMB) recommended to the sponsor, the US Army Surgeon-General, that the trial should continue. It made a similar recommendation at each of the six previous meetings in its role as the independent data monitoring committee.
A statement from the sponsor dated July 20, 2007 is posted.
The last DSMB meeting was special because it was an "interim analysis", the only time before the end of the trial when the data are reviewed to see whether the data collected so far have shown that the vaccine prevents HIV infection.
Only the DSMB has access to this information. It is unusual for a DSMB to stop a trial early, so the recommendation to continue the trial was expected.
The article stated that the goal of this research was to "make the vaccine 80% effective after two years of research". This statement is not correct.
The trial has two objectives: 1) to show that the vaccine reduces infection by 50% compared to placebos; and 2) to show that vaccinated persons who acquire HIV infection through risk behaviour have a reduction in the amount of virus in their blood (viral load).
The article also noted that the "latest results showed only about 50-60% effectiveness".
The DSMB does not provide information on vaccine effectiveness to any person outside its membership. The investigators and sponsor will not know the level of vaccine effectiveness until the end of the trial.
The DSMB simply recommended that the trial be continued. No additional information was provided.
A few minor points should also be mentioned. The sponsor of the trial is the US Army Surgeon-General. The US Army and National Institute of Allergy and Infectious Diseases fund the study. The Ministry of Public Health executes the trial and provides clinical infrastructure and human and technical expertise to conduct the study.
Other collaborators include Mahidol University, the Royal Thai Army, Sanofi-Pasteur, and VaxGen.
There have been many smaller clinical tests of vaccines similar to the combination used in the Phase III trial; these other trials were conducted in North America, South America, the Caribbean and Europe.
A smaller test of this exact combination was conducted in Thailand by investigators from the Royal Thai Army, Mahidol University and the US Army.
There have been only two other Phase III "efficiency" trials conducted for Aids vaccines. Both were conducted with vaccines from VaxGen, called AIDSVAX.
One of those trials was conducted on intravenous drug users in Bangkok. The article mistakenly suggests that vaccine was 50% effective; AIDSVAX alone did not prevent HIV infection.
We thank you for the opportunity to clarify the matter.
DR SUPAMIT CHUNSUTTIWAT, Deputy Director, HIV Vaccine Phase III Trial, Ministry of Public Health
Final phase of Aids vaccine trial extended
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