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Evaluating an Ebola and a Margurg Vaccine in Uganda

2014-08-27 03:18:34 | BioPortfolio

Summary

This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them.

Description

The Ebola and Marburg viruses are both filoviruses known to induce hemorrhagic fever—a set of symptoms characterized by sudden onset, aching, fever, and bleeding in the internal organs. Both filoviruses are associated with high mortality rates, and the Centers for Disease Control (CDC) lists them as Category A bioterrorism agents because of their potential for a major public health impact. Vaccines for both viruses are under development using a prime-boost strategy that involves multiple injections over a period of time to confer long-lasting immunity. Preliminary research supports the vaccines' safety. This study will test these experimental vaccines for the Ebola and Marburg viruses, first administered separately and then together, to ensure they are safe and do not have side effects.

Participation in this study will entail 11 study visits over 2 years. The study will have two parts, to be completed sequentially, and three groups. In part one, participants will be randomly assigned to the first group, which will receive the experimental Ebola DNA vaccine, or the second group, which will receive the experimental Marburg DNA vaccine. In part two, the third group will receive both the Ebola and the Marburg vaccines, one shot in each arm. One fifth of the participants in each group will be controls and receive placebo injections. All vaccines and placebos will be delivered via an intramuscular injection at three time points: at study entry, after 4 weeks, and after 8 weeks.

Participants will complete study assessments at 12 points in time: at baseline and at Weeks 2, 4, 6, 8, 10, 12, 24, 32, 52, 78, and 104. At each assessment, changes in health and medications will be recorded and blood will be drawn. Participants will also complete a diary card daily for 5 days after receiving each injection. In it, they will record their temperature and any skin changes at the injection site.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Conditions

Ebola Virus Disease

Intervention

Ebola vaccine, Marburg vaccine, Placebo injection

Location

Makerere University Walter Reed Project (MUWRP) clinic
Kampala
Uganda

Status

Active, not recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:34-0400

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