Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure

Summary

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Description

Between 1994 and the present, there have been multiple Ebolavirus outbreaks affecting mostly central Africa. However, the 2014/2015 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected, and in disruption of typical activities of civil...

Between 1994 and the present, there have been multiple Ebolavirus outbreaks affecting mostly central Africa. However, the 2014/2015 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected, and in disruption of typical activities of civil society. This protocol is a multi-center study to evaluate the durability of the immune response following the open label administration of the rVSVdeltaG-ZEBOV-GP vaccine (V920) as pre-exposure prophylaxis for adults who have an occupational risk for potential exposure to Ebola virus. The vaccine uses a live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (rVSVdeltaG-ZEBOV-GP also known as V920). All subjects will receive a single dose of rVSVdeltaG-ZEBOV-GP (2 x 10^7 pfu) on Day 0. We will collect adverse events after vaccination and at Month 1 and Month 19, serious adverse events (SAE) for the duration of the study, and assess the immune response at Months 1, 3, 6, 12, 18, 19, 24, 30, and 36. A single booster immunization with the same dose of study vaccine as the primary dose (2 x 10^7 pfu/mL) will be given to those randomized at month 18 to the booster arm of the trial. However, if at any time during the observation period antibody levels fall below a predefined seroprotective threshold (yet to be defined in parallel or newly planned studies), a booster will be offered to those who have not previously received a booster injection.

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