PREVAIL Publish Ebola I Vaccine Results …Study Produce Year-Long Immune Response

 

The Co-Principal Investigator of the Partnership for Research on Ebola Virus in Liberia (PREVAIL) Dr. Fatorma Bolay has released statement on the institution’s Ebola 1 Vaccine Study results published in New England Journal of Medicine at the Ministry of Information, Culture and Tourism (MICAT).

Dr. Bolay said the clinical study was launched on February 2, 2015 and that PREVAIL is still trying to bring the Ebola outbreak under control in Liberia, Guinea, and Sierra Leone.

“Let me hasten to say that PREVAIL conducts collaborative biomedical research in accordance with best practices, to advance science, strengthen health policy and practice, and improve the health of Liberians and people worldwide.

Dr. Bolay said PREVAIL was established in 2014 in response to a request made by former Liberian Health Minister, Dr. Walter Gwinnegale to the US Secretary of Health and Human Services, Sylvia Burwell for the United States Government to assist Liberia in the development of vaccines and therapeutics to tackle Ebola.

He indicated that the project is a joint clinical research partnership between the Liberian and U. S. governments through the Ministry of Health of Liberia and the US National Institutes of Health (NIH).

“PREVAIL 1 was the first large-scale Ebola study conducted in Liberia. Between February 2 and April 30, 2015, 1,500 men and women ages 18 and older were enrolled into the study at Redemption Hospital in New Kru Town in Monrovia. People who enrolled in the study has no reported history of Ebola virus disease. The participants were divided at random into three groups of 500 each,” said Dr. Bolay.

The Prevail Co-Investigator revealed that one group of people received one test vaccine, the second group received another test vaccine, and the third group received a placebo, or saltwater injection, noting that it was important to include the placebo so that their research team could compare how well the test vaccines worked.

“The study was originally designed to enroll 27,000 volunteers to see whether the vaccines could prevent Ebola virus disease. However, it had to be scaled back to be much smaller when the decline in new Ebola cases made it impossible to conduct the larger study,” Dr. Bolay indicated.

He furthered: Participants gave blood samples before vaccination and again at one week, one month, six months, and one year post-vaccination.

The medical practitioner noted that the study team tested each of these samples for infection-fighting antibodies against the Ebola virus and that after one week, only modest levels of antibodies were seen with both vaccines.

However, he revealed that by one month, 71 percent of cAd3-EBOZ recipients and 84 percent of rVSV-ZEBOV recipients developed an antibody response compared with three percent of placebo recipients.

“At one year, the antibody responses were largely maintained in both groups: 64 percent of cAd3-EBOZ recipients and 80 percent of rVSV-ZEBOV recipients had antibody response compared with seven percent of placebo recipients,” Dr. Boley told journalists.

He said that some participants who received the test vaccines had temporary mild to moderate side effects, including headaches, muscle pain, fever and fatigue, stressing that these side effects varied from one person to another.

“Our two volunteers, Emmanuel Lansana and Ambassador Endee, will share their experiences with you all. Overall, no major safety concerns related to the vaccines were identified. The results show that the two test vaccines, cAd3-EBOZ and rVSV-ZEBOV, pose no major safety concerns and can produce immune responses within one month after vaccination that last for at least one year. This result was published in the October 12th issue of the prestigious New England Journal of Medicine,” he indicated.

He stressed: Like my colleague and co-Principal Investigator on the study, Dr. Stephen Kennedy, said two weeks ago, “by developing research capacity and infrastructure to answer questions about Ebola and other infectious disease that are threats to global health, PREVAIL has become a successful model for the implementation of clinical trials during health outbreaks in resource-constrained environments.”

“The other co-leader in addition to Dr. Kennedy and myself is Dr. H. Clifford Lane, Deputy Director for Clinical Research and Special Projects at the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), which sponsored the study in collaboration with the Liberian Ministry of Health (MoH),” said Dr. Bolay

Prevail said the institution is extremely thankful to have enrolled more than a thousand Liberian volunteers into the trial so quickly and to have more than 98 percent of those who enrolled return for their follow-up visits during the year and that the study was a true collaboration with the people of Liberia who participated and made it a success.

“Let me state here that the PREVAIL I study will continue to follow for several years those who had enrolled into the study to determine the long term benefits of the vaccines,” Dr. Bolay noted

“At PREVAIL, we are doing our best to make an impact on the global public health through clinical research. As Tolbert Nyenswah, Director General of the National Public Health Institute of Liberia (NPHIL) noted recently, and I quote, “We cannot succeed in the fight against Ebola unless we identify primary prevention tools.  Through PREVAIL, we are developing vaccines and therapeutics in our region that can help Liberians and the rest of the world“, unquote,” he noted.

He concluded: “The cAd3-EBOZ vaccine candidate was co-developed by NIAID’s Vaccine Research Center and GlaxoSmithKline (GSK), while rVSV-ZEBOV, initially engineered by scientists from the Public Health Agency of Canada, is now licensed to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. GSK. Merck provided the test

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