The Liberia-United States Joint Clinical Research Partnership has announced the start of an Ebola Natural History Study at the J.F.K Medical Hospital in Sinkor, Monrovia.
According to a press release, the study, code-named PREVAIL III, will investigate the variety of health problems faced by Ebola survivors and provide study participants with referral to other healthcare facilities in the country for free treatment.
PREVAIL III is designed to better understand what health problems Ebola survivors experience and to determine whether these conditions are the same or different from health problems people who have recovered from other serious diseases may have experienced.
The release said researchers will also examine whether those, who survived Ebola can transmit Ebola infection to their household contacts or sexual partners, and if so, whether these people get sick with Ebola. Lastly, the study will help to determine if people who survived the Ebola are “immune” or protected from getting Ebola in the future.
“The clinical consequences of surviving the deadly virus disease are a black box with many unknowns,” said Dr. Mosoka Fallah, Principal Investigator for the study and former Ebola Emergency-Response Consultant for Action Contre la Faim – Liberia.
“The study will unravel these unknowns so that optimized clinical care can be provided to survivors while at the same time preparing Liberia and the entire world with the effective prevention and treatment tools for the next Ebola outbreak,” he added.
The release added that the Natural History Study protocol has been approved by the Liberian Ethics and Scientific Review Committee, which reviews human research studies to protect the rights and welfare of the people taking part in those studies; and a scientific and ethics committee known as the Institutional Review Board at the U.S. National Institutes of Health or NIH.
The study is expected to enroll approximately 7,500 people, including 1,500 Ebola survivors and 6,000 of their close contacts.
“This is a major victory for our heroes (survivors) and for public health in general because the results from this study will help to address issues arising from future outbreaks”, said Deputy Health Minister and head of Liberia’s Ebola Incident Management System, Tolbert Nyenswah.
The study will be launched at JFK on June 15th and subsequently open at Redemption Hospital in New Kru Town, Duport Road Health Center, and C. H. Rennie Hospital in Kakata, Margibi County subsequently. Additional sites in Liberia will join the study in the future.
The Ebola Natural History Study is led by a team of Liberians and Americans under the umbrella of a larger Liberia-U.S. bilateral program to build a clinical research partnership and infrastructure here. NIH and the Centers for Disease Control and Prevention are the key U.S. partners on the Ebola Natural History study.
The release said all participants in PREVAIL III will receive a complete physical examination, and that those with eye problems will be referred for treatment, a small blood sample will be collected from participants to study the functioning of the liver and other organs and to see if they have developed any other illnesses, such as HIV/AIDS, that may require treatment, and thereafter if the result is positive, participants will be connected with counseling opportunities and available treatments.
“We welcome the study, and on behalf of the survivors in the country, we feel it could not have come at a better time. It provides a window of opportunity for solutions to be found for the clinical needs that we Ebola survivors face,” noted Patrick Faley, President of Liberia’s Ebola Survivors network.
After their first visit, participants will be asked to return to their study center at three months, six months, twelve months, and then every six months for five years. At each follow-up visit, participants will undergo a physical examination and may be referred to specialized doctors for various complications that may be treated in Liberia.
However, the release noted that because the study is voluntary, participants may withdraw at any time if they do not wish to continue in the study.
The conduct of the study follows the successful completion of enrolment on 30th April of 1,500 volunteers in the Phase 2 PREVAIL Vaccine Study in which there were no major safety concerns, according to Data and Safety Monitoring Board, an independent group, which reviewed the study data.