Key Initiatives

HIV Vaccine Development

Since the discovery of AIDS thirty years ago, close to 30 million lives have been lost to this devastating disease. Another 34 million people are living with HIV and over 7,000 people worldwide become infected each day.  

Recent progress in HIV preventative interventions—including Pre-Exposure Prophylaxis (PrEP) and the first demonstration in humans that a vaccine can prevent HIV infection—have buoyed hope that we may see an AIDS-free generation and an end of this epidemic.  While licensure of an effective vaccine may yet be years in the making, FNIH’s portfolio of HIV/AIDS research projects is working today to expedite achievement of this goal.

The Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTVIMC) is a key component of the Collaboration for AIDS Vaccine Discovery (CAVD). The CAVD is a “big science” approach funded by the Bill & Melinda Gates Foundation to develop an effective vaccine against HIV/AIDS. This collaborative approach brings together a critical mass of HIV vaccine researchers focused on different aspects of HIV vaccine discovery.

The CTVIMC serves as the central T cell immune monitoring facility for the 37 CAVD consortia that pursue a range of innovative strategies to design an effective HIV vaccine. By providing standardized T cell assays for both non-human primate and clinical vaccine trials, the CTVIMC facilitates comparison of efficacy data from different vaccine development efforts across the CAVD (ELISpot; ICS).

The CTVIMC illustrates the potential for NIH to collaborate with philanthropic organizations to achieve mutual goals. Dr. Richard Koup, Chief of the Immunology Laboratory at the Dale and Betty Bumpers Vaccine Research Center (VRC), at the National Institute of Allergy and Infectious Diseases, leads the CTVIMC. In 2010, the CTVIMC completed its first five year period of performance. In 2011, a second five year, $16.8 million award began, again administered by the Foundation for the NIH. Fourteen investigators collaborate to improve T cell testing techniques, with three central clinical laboratories and two non-human primate laboratories that conduct assays to support HIV/AIDS vaccine development.

The Centralized Envelope Collaborative Phase 1 Study is a HIV vaccine development project that focuses on a central problem that has blocked the development of successful HIV vaccine: how to design vaccine immunogens that can address the broad genetic diversity of HIV. This 5 year project, begun in 2009, is co-funded by NIAID’s Division of AIDS and the CAVD (MOSAIC). Led by Dr Barton Haynes from the Duke University Human Vaccine Institute and administered by FNIH, this project brings together stakeholders across the Global HVI Vaccine Enterprise. The project aims to manufacture “mosaic” vaccine candidates, designed in silico via computer simulation, and undertake a proof-of-concept study to test whether these vaccine immunogens are superior to the wild type HIV Env antigen in the breadth and coverage of T cell response they elicit. If successful, this project could enable researchers to accelerate vaccine development by reducing the need for multiple preclinical and clinical trials to optimize immunogen design to achieve the broadest protection.

The Development of a Second Generation Broadly Neutralizing Antibody Product to Prevent HIV-1 Infection in Humans began in 2011, and is another CAVD sponsored collaboration (BNAbs). Advances in the identification of broadly neutralizing antibodies to HIV have raised new opportunities to prevent infection through the administration of antibodies that inhibit activation of diverse strains of the virus. The aim of this project is to optimize an exceptionally broadly neutralizing antibody isolated by researchers at the Vaccine Research Center. Increasing the potency and half-life of the VRC01 antibody could improve its efficacy as a therapy that could be administered by passive immunization, and also provide insights contributing to vaccine design. Dr Gary Nabel, the Director of the VRC, serves as the Principal Investigator on this project, with collaborators at Brigham and Women’s Hospital and the University of Minnesota.