GSK/NIAID Ebola Vaccines To Enter US, UK Human Safety Trials

The Wellcome Trust, the Medical Research Council (MRC), and the UK Department for International Development (DFID) have announced this morning that an Ebola vaccine developed in the U.S. will enter human safety trials in the UK as early as September. The consortium is devoting 2.8 million to the effort.

Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), an arm of the U.S. National Institutes of Health, held a press conference this morning to discuss the specifics about the U.S. vaccine. The FDA has given the green light to begin testing here.

The vaccine was designed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAIDs Vaccine Research Center (VRC). She worked with other collaborators in the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) and scientists at the Swiss-Italian biotechnology company,Okairos, acquired byGlaxoSmithKlinein May, 2013.

Ebola virus particles, colored digitally, emerging from a type of monkey epithelial cell line (Vero) grown in the laboratory. Credit: CDC Public Health Image Library

The GSK/NIAID vaccine has been designed to produce a protective immune reaction toward the surface protein on the Zaire Ebola and Sudan Ebola viruses, a protein required for the virus to normally infect humans. Because its directed at two versions of the viral protein, its called a bivalent vaccine.

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While the vaccine has proven to protect non-human primates from Ebola infection and produced high levels of immunogenic responses, the phase 1 trials are being conducted to ensure that any untoward reactions in humans are detected and the production of protective antibodies proceeds as observed in non-human primates.

NIAID will be starting with typical caution for the first time a vaccine is tested in healthy human volunteers. The trial, termed VRC 207, will ultimately enroll 20 healthy, adult human volunteers (age 18 to 50 years) and evaluate the safety of the virus nine times over a 48-week period and, said Fauci, whether it generates an immune response in healthy adults that, based on our animal studies, could predict effectiveness in preventing the acquisition of Ebola infection.

The volunteers will be split into two groups to receive a high or low dose of the vaccine. The trial will be staged so that small groups of volunteers receive the vaccine at a time, with the first three volunteers to be dosed starting next week at the NIH Clinical Research Center in Bethesda, Maryland. Those three volunteers will be followed for three days before any other volunteers are injected.

We expect to be able to report initial safety and immunogenicity data from this study by the end of this calendar year, said Dr. Fauci.

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GSK/NIAID Ebola Vaccines To Enter US, UK Human Safety Trials