The recent enrolment of the first volunteer at the Tuberculosis Research Centre in Chennai for a Phase I prime-boost AIDS vaccine clinical trial to be conducted simultaneously at the centre and the National AIDS Research Institute in Pune marks a new beginning in the search for a real AIDS vaccine. Two vaccine trials were done earlier but this is quite different. A prime-boost strategy is primarily meant to enhance and prolong the immune response to the disease. In this case, Advax, a DNA candidate vaccine, will be used for priming the immune response and Modified Vaccinia Ankara (MVA) for boosting it. The MVA vaccine was tested recently during the Phase I AIDS vaccine trial at the TRC. While all the volunteers who received this vaccine produced an immune response, its level was modest and its persistence was not very encouraging. The significance of the new trial lies in the fact that priming the immune response prior to administering the MVA may help enhance the immune response. The MVA vaccine used in the trials was developed by the Kolkata-based National Institute of Cholera and Enteric Diseases along with the trial sponsor, the International AIDS Vaccine Initiative (IAVI).
Unfortunately, while the trial has been registered in the Clinical Trials Registry-India, the Indian government and the sponsor have not complied with clinical trial registration best practice. Although registration of trials is not mandatory yet, the registry run by the government recommends that registration be done prior to the enrolment of the first volunteer. This is also one of the recommendations of the World Health Organisation’s International Clinical Trial Registry Platform and the recently amended Declaration of Helsinki in the interest of introducing more transparency and accountability in clinical trials. In the present case, the commencement of the trial was announced in the first week of February, the first volunteer was enrolled on April 1, and registration was done only a week later. It is unfortunate that at a time when India is conducting a large number of trials, the government squandered an opportunity to set a benchmark for registering trials. The good news is that the two institutes where the Phase I prime-boost trial will be conducted have maintained high scientific and ethical standards and refused to buckle under any external pressure while doing the two earlier AIDS vaccine trials.