A forensic review and evaluation of the regulatory and ethical framework governing health-related research in post-ebola Liberia.

Masters Degree. University of KwaZulu-Natal, Pietermaritzburg.ABSTRACT BACKGROUND The end of the deadly 2014 Ebola outbreak in Liberia has seen a noticeable influx of western researchers into the country. Given the vulnerable nature of the majority of Liberians (impoverished and poorly educated), this raises a lot of ethical concerns. This study sought to gauge the local research governance frameworks to discover what protective structures and documented stipulations exist, since there has never been any such assessment. METHODOLOGY The study made use of a triangulated qualitative design, involving a desk review of fifteen (15) national guidelines, policies, procedures, and regulations, coupled with eleven (11) in-depth key informant interviews with purposively-identified oversight institutions and some researchers. RESULTS Key documents (Public Health Law, National Research for Health Policy, and the Clinical Trial Guidelines, National Research Ethics Board Guidelines, and the University of Liberia – Pacific Institute for Research and Evaluation IRB Handbook), along with key institutions (Ministry of Health, the National Public Health Institute of Liberia, the Liberia Medicines and Health Products Regulatory Authority, the National Research Ethics Board, and the University of Liberia – Pacific Institute for Research and Evaluation (UL-PIRE) IRB) were found to be critical to the overall governance, review, approval, and monitoring of health research in Liberia. The frameworks governing health research were found to contain most of the traditional protective stipulations, though significant gaps were also identified from the desk review and in-depth interview with the major stakeholders. Stipulations on emerging issues (stored samples, bio-banks, genetic/genomic research, and data ownership and sharing) and contextually relevant issues (post-trial access, ancillary care, and consent in local languages) are evidently absent or only fleetingly mentioned. CONCLUSION Overall, Liberia appears to have in place the relevant foundational frameworks for acceptable governance of health research. However, the documents are in need of substantial overhaul and contextualisation, especially given the rapidity with which legal and ethical governance of health research has advanced over the past few decades. The local institutional governance is also in need of reorganisation, something that will enhance adequate coordination and management of health research

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

International audienceAbstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. Discussion The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. Trial registration ClinicalTrials.gov NCT02876328 . Registered on 23 August 2016