Monrovia – The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a joint Liberia-U.S. clinical research partnership, wishes to clarify information regarding its work in Liberia.
PREVAIL’s clarifications come amid false claims made by the Dean of the A. M. Doglioti College of Medicine at the University of Liberia, Dr. Vuyu Ganda Golakai, against the joint research program that were published on August 18 in the Daily Observer.
PREVAIL was established in response to a request made by the former Liberian Minister of Health, Dr. Walter Gwinegale, to the U.S. Secretary of Health and Human Services at the height of the 2014-15 Ebola outbreak.
The request sought assistance in developing a collaboration between the U.S. and Liberian governments to conduct research on promising therapeutics for Ebola virus disease and vaccines for its prevention.
The joint Liberia-U.S. clinical research partnership was formally established in the fall of 2014. Subsequently, the U.S. Food and Drug Administration and additional Liberian and U.S. ethics and regulatory boards reviewed and approved its proposed operations before they began in February 2015.
A joint team of Liberian and U.S. scientists was constituted to develop the clinical protocol for the initial Ebola vaccine study, known as PREVAIL I. The Chairman of the Liberia Ebola Incident Management System, Hon. Tolbert Nyenswah, designated Dr. Stephen Kennedy to lead the Liberian team of scientists.
A technical team consisting of Liberians with expertise in clinical research was established to collaborate with their U.S. counterparts.
A number of consultative meetings were held with relevant stakeholders to ensure that the process was conducted in accordance with national policies and international clinical research guidelines.
In addition, PREVAIL developed and implemented Social Mobilization, Community Engagement and Communication strategies to educate Liberians at the leadership and community levels about Ebola disease and the clinical research. Feedback from those consultative meetings resulted in amendments to the protocol to ensure that the concerns of the Liberian people regarding research were addressed where possible.
It is important to note that clinical research is necessary before any medication is approved for human use. All medications must be properly researched and approved by recognized regulatory authorities before they can be authorized for human use.
The West African Ebola outbreak, though devastating and unfortunate, presented the opportunity to research vaccines and therapeutics that could potentially prevent or mitigate the devastation of future epidemics. Liberians are now recognized globally for having played a critical role in that effort.
PREVAIL has made massive investments in building the clinical research capacity of Liberia – from infrastructure development of sites at the Redemption Hospital, Duport Road Health Center, the C.H Rennie Hospital, and the JKF Memorial Medical Center to training of Liberian healthcare professionals, pharmacists, and lab technicians in conducting clinical research according to international standards.
As part of Liberia’s contribution to the Research Partnership, the administration of the JFK Medical Center committed the East Wing of the first floor of the JFK Medical Center, which PREVAIL fully renovated and equipped as a state-of-the-art clinical research center.
The Ebola Natural History Study, a 5-year clinical research study that is investigating the long-term medical impact of Ebola on survivors and their close contacts, is being conducted at this center along with other PREVAIL sites at the Duport Road Health Center and CH Rennie Memorial Hospital.
PREVAIL has concluded its first vaccine study in 1,500 Liberians at the clinical research site at Redemption Hospital. Through the social mobilization and community engagement efforts for that study, Liberians were educated on the difference between a vaccine (which is given to prevent a disease) and a therapy (which is used to treat or cure a disease).
The findings from the Vaccine Study in Liberia proved that it was safe to be used in humans and it generated an immune response that would protect against infection with the Ebola virus.
The findings from the PREVAIL vaccine research in Liberia helped inform the implementation of the ring vaccination in Guinea, which the WHO credited with helping to end the transmission of Ebola in Guinea.
In addition, PREVAIL joined forces with a number of international partners to control the spread of Ebola during the recent sporadic outbreaks by making available the vaccine that was used in those response efforts.
As a result of PREVAIL’s work, a discussion has now been initiated among the Liberian Ministry of Health, MSF, and Merck (manufacturer of the vaccine) to use the VSV Ebola vaccine as part of the ministry-led public health response to future Ebola outbreaks in Liberia as part of an expanded access research protocol.
The experimental Ebola therapy called ZMapp was introduced in Liberia in March 2015. The first person in the ZMapp trial was enrolled in the United States before its introduction in Liberia. ZMapp is not a vaccine but an experimental Ebola therapy to treat people who are sick with Ebola.
PREVAIL’s Ebola Natural History study, initiated more than one year ago, continues to chronicle the medical and psychosocial impacts of having survived the disease, and how research intervention could influence positive change for the larger Ebola survivor population. To date, the study has revealed the medical and psychosocial complications of most Ebola survivors.
These results demonstrate the critical need for comprehensive clinical care, and make the case for national and global policies that will ensure the right to healthcare for all Ebola survivors.
Additionally, the risk of future outbreaks due to Ebola virus persistence among the over 15,000 survivors in the three most affected Mano River Union Countries is currently being studied by PREVAIL.
A new candidate drug that was adMinistered to the Scottish nurse who was infected with Ebola and had a recurrence but recovered is currently being tested at the JFK PREVAIL site in Ebola survivors. The study is trying to determine whether this drug will be effective in eliminating or reducing the level of virus in Ebola survivors and thus preventing future transmission.
In additional to infrastructure and workforce development, PREVAIL has continued to provide international training opportunities to Liberian scientists and other staff abroad.
Five Liberian Laboratory technicians from the National Reference Lab and the LIBR have recently completed training in molecular diagnostics of infectious disease at the Broad Institute, part of the Harvard University and MIT collaboration in Boston, Massachusetts. In addition, PREVAIL recently provided a promising young Liberian with the opportunity to study for the Master’s Degree in Bioethics at the Harvard Medical School in the United States.
