Therapeutic Vaccine Consensus Statement

2011 HIV Therapeutic Vaccine Development Consensus Statement

“I believe that given our current knowledge and innovative tools and concepts, a functional cure is a more realistic goal for the near future. A cure will require funding commitments, strong community engagement, rigorous and innovative scientific endeavor and, above all, further collaborative multidisciplinary science with a better connection between basic and clinical research- in short, all the same ingredients that got us where we are today with the global antiretroviral treatment.

30 years is a long time and yes, we still do not have a cure. But if we do not start seriously looking for one, now that the science is telling us that perhaps we should be, do we want to be here in another 30 years regretting that we did not try?”

Françoise Barré-Sinoussi
Towards an HIV Cure
The New York Times
June 3, 2011

Almost three decades of experience defining the limits of antiretroviral therapy and identifying key mechanisms of disease progression compels the development of new clinical approaches to address HIV infection. A therapeutic vaccine to address latent HIV infection, the evolutionary diversity of proliferating viremia in sanctuary regions and the preservation of HIV specific immune responses is currently a viable approach in advanced stages of development.

An analysis of the potential clinical benefit of a therapeutic vaccine that induces HIV-specific immune responses found that even a modestly effective vaccine would result in meaningful increases in life expectancy and delays in disease progression in people living with HIV on HAART and would allow us to drastically reduce the disparity and non- ability to provide HIV treatment to the more than 50% of individuals around the world living with HIV who still have no access to antiretroviral therapy.

Recent data on a number of therapies in advanced stages of clinical development have shown them to be promising candidates for the treatment of HIV and warrant further investigation and support, as well as remind the community that the development of an effective therapeutic vaccine could lead to a functional cure. Therefore, we call for a reform of the international research agenda to prioritize therapeutic vaccine research and ensure that it is properly funded and proceeds rapidly and coherently.

Current challenges to the development of an effective HIV therapeutic vaccine and other approaches to a functional cure being researched include:
• Facilitation via federal funding is grossly inadequate to support the research currently being conducted as well as new therapeutic vaccine agents; current funding dedicated to HIV research to develop a functional cure is only 1% of total HIV funding and less then 1/60 of the global AIDS budget
• While there was a small initiative by the Basic Sciences Program at the Division of AIDS for a few years that funded the efforts of 2 or 3 groups, the U.S. government currently has no mechanism for the facilitation and coordination of translational research on a therapeutic HIV vaccine and no NGO has been formed to do so, as has been done for preventive HIV vaccine research through IAVI, AVAC and the Global AIDS Vaccine Enterprise
• The lack of financial incentive for pharmaceutical companies to develop a therapeutic HIV vaccine, as the small biotechnology companies developing these therapies cannot raise the private funding necessary to continue their research in the current market
• Financial constraints and convolutions in the private sector during the current global economic crisis have forestalled further clinical and commercial development of numerous investigations

Like all advances in HIV research, overcoming the challenges listed above will take capital, inspiration and collaboration. This document is proposing the direction of funding levels similar to that spend on preventive vaccine research to facilitate the continued development of promising HIV therapeutic vaccines. Given the potential of recent advances, the problem of HIV drug resistance and the disparity in access to ARVs that now characterizes the pandemic, we urge the development of HIV therapeutic vaccine research be made a foremost priority.

It is crucial that promising HIV therapeutic vaccine candidates in commercial development or being researched at academic institutions are afforded the necessary facilitation to expedite the clinical maturation of this promising arena.
These include:
• Therapeutic vaccines
o Vacc4x is a Phase IIb therapeutic vaccine based on four synthetic slightly modified peptide sequences from highly conserved regions of p24
o VRX1273 is a therapeutic vaccine in preclinical development
o Dermavir is a Phase IIb topically administered nanoparticle DNA-based therapeutic vaccine
o CDVaxx-001 is a Phase I APC-targeted vaccine consisting of a fusion protein of a human monoclonal antibody with specificity for the dendritic cell receptor DEC-205
o FIT-06 is a...