Presentation at the International Conference on Vaccine R&D, Baltimore MD, 04 November, 2015

November 27, 2015

Methodological challenges in the Clinical Development of HIV Therapeutic Vaccines.

Infection with Human Immunodeficiency Virus (HIV) is a chronic clinical state where discrete, viral replication and homeostatic proliferation of infected memory T cells maintain HIV reservoirs. The medical management of HIV is regarded as a major R&D achievement and collaborative model. Antiretroviral therapy has averted ~6.6 million AIDS-related deaths. Globally, an estimated 35.3 (32.2–38.8) million People are living with HIV. Key considerations for HIV therapeutic vaccine R&D include:

• Validated, robust, methods and biomarkers, to quantify HIV viral reservoirs, reproducible in clinical trials.
• Standardized pre-clinical assessment requirements including for vaccine combinations.
• Clinical trial design, adaptive and innovative to allow robust phase II evaluations of vaccine and in combination for HIV functional cure.

Two approaches, empirical advocating for faster human clinical trials, or theoretical aiming, at first to complete, the mechanistic understanding of the HIV immune response, methodologically confront, and will eventually complement, each other.