“This is the third week of the study vaccine. We now have 540 persons including those who have been vaccinated and others who have signed up to take the vaccine.” This is Dr. Stephen B. Kennedy, Co-principal investigator of Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), a joint Liberia-US partnership for the clinical Ebola vaccine study in Liberia, beaming with smiles as he told our Health Desk of the success of the study vaccine.
This Liberia-U.S. joint clinical research partnership aims at studying common infectious diseases in Liberia and developing Liberian clinical research capacity.
Providing updates to the Observer in an exclusive interview at his 12th Street office in Sinkor yesterday, Dr. Kennedy disclosed that his team is waiting for the last 60 persons to sign up or volunteer for the study vaccine. The 60 will complete the 600 figure which was earmarked for the second phase of the trial vaccine study that is ongoing in Liberia. This phase is to last for six weeks.
According to Dr. Kennedy, 104 volunteers were vaccinated in the first week, which began on February 2. In the second week, because of the Armed Forces Day holiday, 96 were seen. Weeks one and two represent at least 34 percent of the total enrollment for the study vaccine.
He stated that 336 volunteers, who have all gone through the formalities leading up to being inoculated, now have their tickets and are just waiting to be vaccinated.
The PREVAIL Co-investigator disclosed to our Health Correspondent that by the end of today or tomorrow, the enrollment process will stop because all 600 persons for this phase would have been admitted.
“This is highly successful because of the mass turnout from volunteers, who are coming everyday to be a part of the study,” he stated referring to the success of the vaccine.
Vaccine Side Effects
Dr. Kennedy, who was one of the volunteers to participate in the trial process, said in the first week, at least 42 episodes of “typical side effects” were reported to the study team.
“Episode does not mean 42 persons reporting symptoms but one person reporting one, two or three side effects like slight joint pains, headache, and fever. So in week one, we received at least 42 reports from some of the volunteers.”
According to him, most of these side effects are also associated with some of the other everyday drugs presently in existence.
“I, too, was vaccinated in week one. I reported headache and fever as side effects. Dr. Francis Kateh, too, reported the same symptoms,” Dr. Kennedy told the Observer.
He said those effects only lasted for at most 24 hours and they were gone.
The PREVAIL Co-principal investigator further stated that in week two, only 11 episodes were reported to the study team. He assumed that the difference between the first and second weeks’ side effects reports is due to “the issue of anxiety in the first week. Since that was the first week and the trial was just beginning, people were a bit anxious.”
He disclosed that the percentage of side effect episodes reported in Liberia is far “significantly lower” than the one that was reported in other countries, including US, Mali, Switzerland, where the first phase of the trial took place.
He said that with this “significantly lower” episode reports, there were several things to point to, including the “vaccines being highly safe.”
Purpose of the Trial
Dr. Kennedy said the purpose of the study vaccine in Liberia, which is the hardest hit Ebola nation, is to establish if the vaccine is safe over a longer time, to also establish the body’s Immune System’s response to the vaccine and how long the vaccine lasts in the body.
He also stated that at the end of this six-week phase two trial, his team will be able to determine the efficacy (effectiveness) of the vaccine.
He said that in phase one, which was conducted outside Liberia, the study team wanted to determine the safety of the vaccine and to also know the appropriate dose for the phase two trial.
Third and Final Phase
Like the second phase, Liberia is again going to be the first nation to begin the third and final phase of the vaccine trial exercises. This phase is set to begin in May of this year and expected to last at least a year, according to Dr. Kennedy. PREVAIL and her US partners have planned to enroll at least 27,000 volunteers to take part.
However, Dr. Kennedy said, depending on how effective the vaccine will be the World Health Organization (WHO) can hasten this phase and reduce the one-year trial phase.
He further disclosed that this phase will also be conducted in Sierra Leone and Guinea, which are the other two worst Ebola hit nations.
Liberia’s Role and What It Stands to Benefit
“Do we always just want to be receivers and not contributors, too? We need to go down in history as contributors to global public health. From this we are going to be recognized as contributors to global public health,” Dr. Kennedy told our Health Desk.
He maintained that if they were to establish that the vaccine works, some quantity of the drugs would be given to Liberia for use in case of any future outbreak.
He also stated that Liberia stands to also benefit from royalties from the sale of the drug in the future.
About the Vaccine
The process leading up to the vaccine trial started in August 2014 when the then Minister of Health & Social Welfare, Dr. Walter Gwenigale wrote a letter to the U.S. Secretary of Health, Sylvia Burwell, to ask for a Liberia-U.S. collaboration to conduct clinical research to develop vaccines and treatments for Ebola.
The vaccine study took off in October 2014 when the two governments formed a partnership with the goal to learn more about Ebola, find a vaccine to prevent it, and treatments that can heal people coming down with it.
The Ebola vaccine study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the U.S. National Institutes of Health (NIH).
The study assesses the safety and effectiveness of two test vaccines that are designed to prevent Ebola.
This study of Ebola vaccines at the Redemption Hospital is funded by the Liberian Ministry of Health and the U.S. National Institutes of Health, and the vaccines being tested are ChAd3-EBO-Z, which is made by GlaxoSmithKline, and the other, Rvsv-ZEBOV, made by Merck and NewLink.
The study is designed to determine if a single dose of a test vaccine will prevent the Ebola virus disease (EVD).
The clinical trial is led by Dr. Stephen Kennedy, MD, MPH, FLCP, (Liberia Co-Principal Investigator), and Dr. H. Clifford Lane, (M.D) Clinical Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Before the volunteers are inoculated, they receive a detailed explanation of the purpose of the study, what procedures the study entails (e.g., collection of urine and blood samples), the side effects or discomforts that could occur after receiving the vaccination, and any possible benefit that could come from their participation.