To ensure the effectiveness of two newly developed vaccines that fight against the Ebola Virus Disease (EVD), twelve Liberian volunteers yesterday received trial vaccines in the first ever Ebola Study at the Redemption Hospital in New Kru Town, Monrovia.
The vaccines are the ChAd3, manufactured by Glaxo SmithKline, and the rVSV-ZEBOV which is manufactured by Merck/NewLink.
Administering the vaccines to the volunteers, Liberian registered pharmacists, in protective gear, prepared the Ebola test vaccines from vials to syringes and brought them from a nearby holding center to the Redemption Hospital, where they were administered.
Hospital staff briefed the twelve selected volunteers about the process and the purpose of the study, after they were screened to ensure that they were eligible to participate in the trial.
“You cannot participate in this study,” a hospital staff told the volunteers, “if you are suffering from fever; when you are pregnant or breastfeeding a child.” After additional information was provided, the qualified candidates were sanctioned by the authorities to proceed with the study.
As quietly as it had begun, the process continued and all twelve participants were vaccinated. Yesterday’s study is part of the first 600 vaccinations to be conducted. The procedure entails collection of urine and blood samples; the side effects or discomforts that could occur after receiving the vaccination, and the possible benefit that could come from their participation.
All the volunteers had the opportunity to have their questions answered before making their own decision about whether or not to participate.
“This is a process that had been thoroughly reviewed by research ethics boards in Liberia and the U.S.,” health officials said.
Officials told that Daily Observer that the volunteers, “were advised that they were at liberty to decline participation and withdraw their consent at any time without consequence.” Meanwhile, the twelve participants will be closely monitored and their reactions documented to be reviewed periodically by an independent Data and Safety Monitoring Board of medical and scientific experts from the United States and Liberia.
The Daily Observer learned that the clinical development process for the test vaccines began with Phase 1 testing for safety (assessment of side effects or adverse events) in a small number of human volunteers.
“Several Phase 1 studies of Chad3-ZEBOV and rVSV-ZEBOV have been conducted and most of the adverse events reported in these studies were mild and did not last long,” officials said. “A few study volunteers experienced fever and joint pain that lasted for a few days and ended within two weeks. The most people who received the vaccines in these studies developed infection-fighting proteins, or antibodies, that might help to protect them from getting EVD.” Reports from the twelve participants reaching the Daily Observer did not indicate any negative effect.
Up to press time, there were no immediate report of negative reactions in any of the twelve volunteers and officials expressed optimism of the trials.