The Ebola Virus Disease (EVD) took center stage with the outbreak in West Africa in 2014, and was declared a Public Health Emergency of International Concern by the World Health Organization (WHO).
A strong partnership with the Nigerian military and its large network of medical facilities and well-trained personnel provides a platform to conduct surveillance and clinical research on infectious disease threats including Ebola. The Government of Nigeria officially opened a new Clinical Trials Center (CRC) in 2015 in Abuja to accommodate the program’s Ebola and HIV vaccine studies.
The Nigerian Ministry of Defence Health Implementation Program (NMOD-HIP), in collaboration with MHRP, launched its first Ebola vaccine study, RV429, in Abuja in August 2015 as part of GlaxoSmithKline’s Phase 2 chimpanzee Adenovirus Type 3 (ChAd3) Ebola glycoprotein study. This is a randomized, observer-blind, placebo-controlled study to assess the safety and immunogenicity of GSK’s vaccine candidate.
This study involves five African countries; Cameroon, Mali, Nigeria and Senegal, enrolling a total enrollment of 3000 participants in their Phase 2 trial program. Nigeria is contributing 330 volunteers to the research pool.
RV456 is a randomized, observer-blind, placebo-controlled, Phase 2 study that includes two vaccine candidates: Ad26ZEBOV from Janssen Pharmaceutical company of Johnson & Johnson, and MVA-BN-Filo from Bavarian Nordic. These will be given sequentially in a “prime boost” regimen.
The purpose of this study is to assess the safety and tolerability of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo vaccines and to evaluate its immune response to the Ebola vaccine. These vaccines are expected to stimulate the body’s immune system and provide protection against infections with the Ebola virus. A total of 575 volunteers will be enrolled in this study which will be conducted in Nigeria, Kenya, Uganda, Tanzania, Mozambique and United States of America. The program’s Clinical Research Centre in Abuja will enroll approximately 50 healthy volunteers including persons living with HIV.