Conduct of efficacy trials will be one of the major bottlenecks in the development of HIV vaccine, feels Dr. Jean-Louis Excler, Medical Director, International AIDS Vaccine Initiative (IAVI) India. The recruitment of volunteers for both phase 1 and phase III trials has also been sighted as a major difficulty that researchers are to overcome.
Speaking at the 26th National Conference of Indian Association for Study of Sexually Transmitted Diseases & AIDS, which started here on Friday, Dr Excler said that the first HIV vaccine tailored to Indian needs: HIV-1 subtype C genes, (Modified Vaccinia Ankara or "MVA") has been developed by Therion with Indian scientists, and has been manufactured by Therion for first phase I trials. The technology of the vaccine manufacturing is to be transfered from Therion to Indian manufacturer(s) for further clinical trials, he said. The recruitment of volunteers will certainly be one of the major difficulties for both phase I and phase III studies. The phase I trial would be conducted by National AIDS Research Institute (NARI), Pune, he informed.
"Site assessments and site selection should proceed as soon as possible. Cohort studies should then be conducted to study the feasibility, quality and "take" of VCT, retention rate, risk behavior reduction, NGO/CBO involvement, incidence measurement, access and level of care and support for HIV-infected patients. Some other non-science issues e.g. media, community perceptions will also been evaluated," he explained.
He reminded that HIV vaccine development is a long and demanding effort that imperatively needs a concerted effort and long-term commitment from all key players.
Two main bodies of technical activities are conducted hand in hand and cannot be separated: preparedness and research and development, he said.
Commitment and support at the National and State political level, community level involvement and acceptance are all needed to educate, and involve potential participants, families, friends, co-workers, physicians, NGOs, civil society, he noted.
Designing the overall R&D strategy, effectively implementing clinical trials, and ensuring appropriate technology transfer would be the scientific challenges. "Long term commitment of all key players is needed as well as transparency of the process, and accept to share risk and possible failure. Another set of activities is dedicated to study and prepare communities for vaccine access and vaccine deployment strategies," he said.
Elaborating on the activities of IAVI, he said that advocacy, information and consultation are three other pillars bringing the necessary support to its programmes. "Qualitative Research, communication through IAVI's newsletter (Sankalp), IAVI's website, and media interactions illustrate this effort. An Advisory Board and Panel of Experts have also been constituted and divided in eight working subgroups including advocacy and communication, informed consent, management and care issues, local community mobilisation and recruitment of volunteers, access and Public Health vaccine strategy, manufacturing and industrial planning (patents and production issues), comprehensive legislation, and epidemiology, final design and statistical guidelines."
India got involved in HIV vaccine R&D after it started the national and international collaborative initiatives between ICMR, NACO, the US Vaccine Trial Network with Johns Hopkins University (US NIH-funded).
HIV vaccine R&D in South East Asia countries was initiated eight years ago in Thailand and since has proven to be very active and successful. Thailand has played and is still playing a major pioneer and leadership role and has catalyzed numerous initiatives with the constant support and active participation of WHO-UNAIDS, he said.