Study will evaluate a prime-boost Ebola vaccine regimen in both healthy and HIV-infected volunteers
The U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR) initiated a Phase 2 clinical trial to evaluate the safety and immunogenicity of a prime-boost Ebola vaccine regimen in both healthy and HIV-infected volunteers. The multisite study began today with its first vaccination in Uganda. The trial will also take place in Nigeria, Kenya, Tanzania and Mozambique.
This study, which will enroll a total of 575 volunteers, includes two vaccine candidates, Ad26.ZEBOV from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson; and MVA-BN-Filo from Bavarian Nordic, which will be given sequentially as a "prime boost" regimen. The study will also test a vaccination schedule beginning with Ad26.ZEBOV and then boosted with MVA-BN-Filo. Researchers will assess the safety and tolerability of the vaccine schedules and characterize and compare the immune response elicited by these different regimens.
Janssen and other development partners have generated data from several previous studies of healthy subjects demonstrating that both regimens were safe and immunogenic. The new study will extend the population studied in Phase 1 to include volunteers up to and including 70 years of age and volunteers with stably suppressed HIV-infection. Part 1 of the study began at WRAIR last year, where they enrolled 75 volunteers.
"It is critical that we know these vaccines are safe and immunogenic in the communities where they will be used in Africa," said Lt. Col. Julie Ake, an infectious disease physician, U.S. Military HIV Research Program (MHRP) Principal Deputy and protocol chair for the international study.
The study includes HIV-infected volunteers because they represent some of those who might benefit from a preventive Ebola vaccine in Africa. "It's an important consideration given that both of these viruses can be present in the same communities," said Col. Nelson Michael, MHRP Director.
This clinical trial is a collaboration between WRAIR and Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, with funding from the Joint Vaccines Acquisition Program at the Department of Defense's Joint Program Executive Office for Chemical and Biological Defense.
This is the fourth Ebola vaccine study conducted in Africa by WRAIR and MHRP.