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First Ebola Vaccine Study in Africa
In 2009-10, MHRP’s site in Uganda, the Makerere University Walter Reed Project (MUWRP), led the first Ebola vaccine clinical trial in Africa. MUWRP tested an early-generation DNA vaccine developed by NIAID’s Vaccine Research Center and found both the Ebola and Marburg DNA vaccines to be safe and immunogenic in an African setting. The results were published online in the Dec. 2014 edition of The Lancet and helped lead to a clinical evaluation of a more potent ChAd3 vaccine, co-developed by NIAID and GlaxoSmithKline.
Launching New Ebola Vaccine Trials in Africa
MUWRP began testing the new vaccine in a Phase Ib study in early 2015. As part of this study, some Ugandan volunteers from the 2009 DNA study received a boost, or additional injection, with the new vaccine candidate to explore a more long lasting effect of vaccination.
The Walter Reed Program Nigeria (WRP-N) also began testing the same ChAd3 Ebola vaccine in a larger Phase II study in August 2015 and has already exceeded its enrollment target. This study will take place at 10 sites in four West African countries.
In December 2015, a multisite Ebola vaccine study, referred to as EBOVAC 2, began in the US and Africa sponsored by Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Our site in Uganda, MUWRP, is participating in this phase I/IIa trial to test the safety, tolerability and immunogenicity of prime-boost regimens of the candidate vaccines Ad26.ZEBOV and MVA-BN-Filo in healthy adults and elderly subjects, and HIV infected subjects.
New Multisite Prime Boost Regimen Trial
In early 2016, MHRP initiated a new multi-site Phase 2 clinical trial to evaluate the safety and immunogenicity of a prime-boost Ebola vaccine regimen in both healthy and HIV-infected study volunteers.
This study includes the same two vaccine candidates, Ad26.ZEBOV from Crucell Holland B.V., and MVA-BN-Filo from Bavarian Nordic, which will be given sequentially as a “prime boost” regimen. The trial began in early 2016 at the WRAIR Clinical Trials Center in Silver Spring, Md. Later in 2016, MHRP-affiliated sites in Africa will also begin evaluating this regimen, as well as a vaccination schedule beginning with Ad26.ZEBOV and then boosted with MVA-BN-Filo.
Diagnostic Expertise Provides Crucial Support to Ebola Efforts
MHRP's HIV diagnostic research lab provides crucial laboratory support for another novel Ebola vaccine candidate currently being tested at WRAIR. NewLink Genetics and Merck Vaccines USA developed the VSV-EBOV candidate in collaboration with the Public Health Agency of Canada.
This clinical trial began in October 2014 during the peak of the devastating Ebola outbreak in West Africa. WRAIR researchers took part in developing the necessary assays to characterize vaccine safety and immune response. Critical support was provided by the Army Medical Research Institute of Infectious Diseases (USAMRID) and the DoD Chemical Biological Defense Program. These lab tests are used in clinical studies, and may be used as reference assays to support future trials of this vaccine candidate. Study results were published in the New England Journal of Medicine in 2015.
Leveraging WRAIR Expertise for Ebola
WRAIR’s agility and ability to quickly redirect resources helped accomplish an acute mission need for Operation United Assistance. WRAIR colleagues:
- Supported pre-deployment training course
- Assessed deployment mental health stressors
- Provided technical assistance for foreign nation allies in developing diagnostics capabilities
During the outbreak, WRAIR scientists assisted local ethical and regulatory authorities as they strove to expedite vaccine trials and consulted with the World Health Organization to help guide Ebola vaccine development policy.
WRAIR researchers continue to learn from past Ebola outbreaks. In 2015, they published a paper on the largest, long-term follow up study on Ebola survivors of the 2007-2008 Bundibugyo ebolavirus (BDBV) outbreak in Uganda, which showed long-term adverse health effects of the virus last more than two years.