As Thailand prepares for the largest HIV vaccine trial planned to date, concerns have been expressed about the level of community involvement in those plans. As previously reported here, nearly 16,000 volunteers will be sought to find out whether a two-stage vaccine can protect against HIV or AIDS. With the cancellation of a parallel trial in the Americas after disappointing levels of immune responses, this is the only full-scale trial that could start in the current year.
From a report of a seminar on HIV vaccine development in the Bangkok Post, the level of knowledge about the trial remains very low in the areas where it is due to take place – in Chon Buri and Rayon provinces. While the trial is still subject to approval through an increasingly strict official process, there are grounds for concern given that the aim is to begin the trial before the end of this year. Speakers at the seminar also said that while most vaccine research in Thailand had been well conducted, there had been some complaints from trial volunteers and there had not been enough community involvement in the VaxGen trial, which continues (see below).
The director of the trial project, Dr Supachai Rerk-ngarm, is quoted as saying that the trial could not succeed without community involvment, and that this would be addressed.
ICASO publishes new briefing
At the forthcoming International Conference on AIDS in Barcelona, there will be a number of meetings relating to community involvement in vaccine research, including two satellite meetings immediately before. The International Council of AIDS Service Organizations is launching the second edition of its guide for community organisations, which is now available from the ICASO website and can be downloaded from here.
aidsmap.com resources on vaccine development
The development and testing of HIV vaccines, including some of the ethical issues, are surveyed on aidsmap.com here (note that there are two pages in this list).
Approaches to vaccine design are surveyed here. This is due to be updated following the Barcelona conference.
There is also a links page on vaccines here.
VaxGen: the history
The new trial is radically different from the ongoing VaxGen trial, which is run in partnership with the Bangkok Metropolitan Authority and is maintaining contact with some 2,500 injecting drug users who attend clinics in that area.
There were complaints that the VaxGen trial had little community involvement at the start, although trial organisers have said that the population recruited into the trial were not at the time well represented by any of the community organisations. They have set up a community advisory structure during the trial, on which trial participants and their families are represented.
The VaxGen trial in Thailand has reported a higher level of commitment from, and retention of, its volunteers than is reported from sites in the USA and Canada (where most volunteers are gay men). In part, this has depended on the research clinic staff visiting volunteers both in the community and in some cases in prison, although no volunteers were recruited from prisons. Both trials have passed reviews from an independent Data and Safety Monitoring Board and have had lower drop-out rates than allowed for in the trial design.
VaxGen has a website describing its vaccine trials which can be accessed here.