U.S. Military HIV Research Program
A Featured HJF Research Program
The U.S. Military HIV Research Program, HJF’s single largest supported research program, is a leading force in the battle against HIV. MHRP’s seeks to protect U.S. troops and reduce the global impact of the disease through a combined focus on developing an effective HIV vaccine and finding a cure. In addition, MHRP has become a partner in the US Army’s efforts to mitigate emerging infectious disease threats including Ebola and Mediterranean Respiratory Syndrome (MERS).
In August 2015, MHRP sites in Uganda and Thailand began a Phase II study of a new HIV vaccine candidate that uses Ad26 prime with an MVA and protein boost, which is sponsored by Janssen, a division of J&J. The study, called Approach (A004), is a critical path study to down-select for a final regimen to advance to efficacy testing. In addition to contributing sites and collaboratively designing the study and development plans, MHRP provides the MVA being tested in A004.
The landmark RV144 Thai vaccine study, the only vaccine clinical trial to show a modest ability to protect against HIV infection, continues to inform the vaccine field and drive research. In a follow-on study in 2015, MHRP researchers published in Science Translational Medicine, key insights into the role that host-genetics played in protecting against HIV infection in RV144. In addition, MHRP has led clinical research efforts to optimize the RV 144 vaccine regimen by evaluating extended vaccination regimens in a suite of three studies conducted in Thailand.
MHRP researchers continued pre-clinical work on a highly innovative dual-vaccine that would simultaneously address the intertwined epidemics of heroin abuse and HIV. The possibility of creating a combination heroin-HIV vaccine provides an important opportunity to address both a unique treatment for heroin abuse as well as continuing the quest to develop an effective preventive HIV vaccine. The HIV component of the vaccine builds directly upon the results from the RV144 study.
MHRP and collaborators developed a novel, trimeric HIV-1 subtype C gp145 Envelope which may provide a significant improvement to the earlier generation vaccines in clinical testing. The Program is working closely with DAIDS/NIAID/NIH to move this product forward and make it ready for clinical trial testing in 2016.
As MHRP advances the search for an HIV vaccine, it has also expanded its focus on cure research. In 2015, MHRP began planning HIV “cure” studies within its two acute infections cohorts, RV217 and RV254. These studies will evaluate strategies aimed at inducing HIV remission, or controlling virus without the need for long term anti-retroviral treatment. Planned interventions include strategies to give HIV vaccines or broadly neutralizing monoclonal antibody against HIV. MHRP researchers at WRAIR are also exploring immune responses during this early phase of infection, along with genetic changes in the virus.
In the past year, MHRP’s Threat Assessment Division performed research that will help inform military public health policy to protect U.S. Service Members from infectious diseases including HIV. They identified the primary HIV infection attribution category in the Army for the first time since the repeal of Don’t Ask Don’t Tell, which defines a very specific population most at risk for HIV that can now be provided with targeted preventive intervention activities. Another study showed that screening of military applicants for hepatitis C (HCV) via antibody screening and a confirmatory nucleic acid test could reduce enlistment of infected individuals and increase battlefield blood safety.
Beyond HIV, MHRP has leveraged its impressive infrastructure and capabilities to address other global health threats. Results from the first Ebola vaccine clinical trial in Africa, which was conducted by MHRP’s site in Uganda, the Makerere University Walter Reed Project, were published in Lancet. This study confirmed that the immune response and safety profile of candidate Ebola and Marburg vaccines were the same in African populations and the U.S., and showed that the combination of Ebola and Marburg in a single vaccine did not result in diminished immune response for either. Further, MUWRP and collaborators characterized the largest study of long-term outcomes of Ebola among survivors of a 2007 epidemic in Bundibugyo, Uganda.
The MHRP site in Uganda also launched a Phase I vaccine study with the VRC/NIAID/NIH testing a novel Ebola vaccine using ChAd3. In August, MHRP’s Nigeria site began a Phase II Ebola vaccine study using the same ChAd3 vaccine candidate. This is the first MHRP vaccine study to be conducted in Nigeria. Plans are underway for another large Phase II study of an Ad26/MVA Ebola vaccine at WRAIR and MHRP sites in Africa.
MHRP also turned its attention to the emerging threat of Middle East Respiratory Syndrome coronavirus, developing plans to conduct first-in-man studies of a MERS-CoV DNA vaccine at the WRAIR in 2016.
MHRP will continue to focus on conducting research and developing infectious disease countermeasures that both anticipate and quickly respond to the needs of deployed forces as they emerge. We will also leverage internal capabilities at the Walter Reed Army Institute of Research and engage key external partners to hasten progress, maximize resources, and ensure top quality research.