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Phase Ib Ebola/Marburg Vaccine Clinical Trial Begins
MHRP began a collaborative Phase Ib study to evaluate the safety and immunogenicity of Ebola and Marburg DNA plasmid vaccines in healthy adults in Kampala, Uganda.
This study, called RV247, is a randomized, double-blinded, placebo-controlled study that will evaluate the safety, tolerability, and immunogenicity of two recombinant DNA vaccines: one against Ebola virus and one against Marburg virus infections. A second part of the study will evaluate simultaneous administration of the Ebola and Marburg vaccines, which are evaluated independently in part one.
Principal Investigator Dr. Hannah Kibuuka, with the Makerere University Walter Reed Project, and her team started vaccinating volunteers on November 2, 2009. Community interest in the trial has been very positive. The study is designed to enroll 108 volunteers, and already nearly 200 people have signed up for screening.
This is the first Ebola/Marburg vaccine clinical trial to be conducted in Africa. Initial Phase I studies of the vaccine candidates were conducted by the NIAID Vaccine Research Center Clinical Trials Core (Protocol VRC 206) at the NIH in Bethesda, Maryland.
NIAID, Regulatory Compliance and Human Subject Protection Branch (IND sponsor)
NIAID, Vaccine Research Center (vaccine manufacturer)
US Military HIV Research Program
Makerere University Walter Reed Project
Infectious Diseases Clinical Research Program