Bangkok Post - June 19, 2002
Anjira Assavanonda
Lack of transparency in the past had led to abuses and even mistreatment of volunteers, in particular those who were drug addicts, critics said.
Speaking at a seminar on HIV/Aids Vaccine Development and Community Involvement yesterday, Senator Jon Ungphakorn said although trials of candidate vaccines in Thailand were mostly up to standard and proven for safety of volunteers, there were still cases in past trials where the rights of volunteers had been violated and their personal lives affected.
He cited the example of AIDSVAX trial on intravenous drug users in Bangkok in which addicts who volunteered were sometimes treated as if they were criminals.
The senator said he did not object to the trial of HIV candidate vaccines in Thailand but wanted the process to be carried out more carefully and openly.
Despite the fact the trial was to start soon, concerns had been raised by HIV/Aids activists that local communities in the trial sites had not been informed of the project.
Supatra Nakhapiew, of the Centre for Aids Rights (CAR), said there were several issues which should have been clearly explained to the communities involved to help them understand the pros and cons of the trial.
The trial will use a combination of Live Recombinant ALVAC developed by Aventis Pasteur and AIDSVAX subtype B/E from VaxGen. AIDSVAX alone has already been in the phase 3 trial among 2,545 intravenous drug users in Bangkok, which is expected to yield good results.
The combined phase 3 trial of ALVAC and AIDSVAX, on the other hand, will be administered to 16,000 uninfected volunteers aged 20-30 years, in eight districts of Rayong and Chon Buri provinces. The project is still awaiting approval from several committees, both at the national and international level, and is expected to start by the yearend.
Ms Supatra said she was worried information concerning the trial had not yet been passed on to local residents to prepare for whatever changes in their communities.
"Even the staff of my organisation, which has an office in Rayong province, does not know the details of the trial, let alone local villagers," Ms Supatra said.
Mr Jon also said the ministry should launch a serious campaign on Aids prevention. "We should expect that the campaign would at least help reduce the new infection rate, no matter whether the vaccine will prove successful or not," he said.
Besides, it should emphasise building up a strong relationship with the communities to let them know all important issues about the trial and have them participate in the process.
"This might be done by allowing some local representatives to sit on the community relations committee to share opinions and make suggestions regarding the trial process," Mr Jon said.
"All the volunteers should get through the intense HIV prevention campaign to prevent them from risky behaviour. It should be made clear to them that the candidate vaccine might not be effective at all, and being a volunteer did not mean that they would be safe from the virus," he said.
Besides, the communities should be informed of what benefits they would get from the trial, such as priority to obtain the vaccine if the trial succeeded.
Dr Supachai Rerk-ngarm, director of the trial project, promised that community involvement would be a major concern in the trial process.
Since the trial would be the largest so far, it could not succeed without community involvement, he said.
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