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Walter Reed Program-Nigeria Begins Phase 2 Clinical Trial of Ebola Vaccines

The Walter Reed Program-Nigeria recently began a phase 2 clinical trial to evaluate the safety of and the immune responses generated by an investigational prime-boost Ebola vaccine regimen in both healthy HIV-uninfected and HIV-infected adult volunteers.

This study includes two vaccine candidates: Ad26.ZEBOV from Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), and MVA-BN-Filo from Bavarian Nordic. These will be given sequentially in a “prime-boost” regimen.

Volunteers will receive both vaccine candidates in alternating sequences. By giving two vaccines, one after the other, researchers hope to demonstrate durable protection against Ebola. Some volunteers will receive a placebo vaccine (“dummy vaccine”) instead of an active vaccine, to ensure study results will be objective.

Janssen and other collaborators have performed smaller Phase 1 trials on both vaccine candidates in the United States, United Kingdom, Tanzania and Kenya. Results from the U.K. study, published in JAMA: The Journal of the American Medical Association, suggest that the regimen was well-tolerated by healthy individuals and immunogenic (induce an immune response).

Researchers will assess the safety and tolerability of the vaccine schedules and compare the immune responses, which will help identify the most promising sequence to use in the prime-boost regimen. It will also include volunteers up to 70 years of age and volunteers with stably suppressed HIV infection. HIV infected volunteers are included in the study because they too should benefit from an effective preventive Ebola vaccine if one is found.

The vaccines will not cause Ebola infection. The health and safety of all study participants is top priority. Researchers will closely monitor the effects of the vaccine in those who take part in the study. This study will be conducted in Abuja, Nigeria and in other African countries including Kenya, Uganda, Tanzania and Mozambique. Ebola is a serious and often fatal infectious disease found in several African countries. There is no effective treatment or cure for Ebola and availability of an effective vaccine is considered an important tool in controlling the spread of disease and preventing future epidemics.