Ebola vaccine candidate safety study to launch next week at NIH

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The U.S. National Institute of Allergy and Infectious Diseases will begin human testing of a vaccine candidate to prevent Ebola virus disease at the National Institutes of Health Clinical Center in Bethesda, MD, next week, seeking information on the safety and effectiveness in prompting an immune system response of the investigational product. The product was developed jointly by NIAID and the pharmaceutical company GlaxoSmithKline.

The study will be the first in a series of safety studies of potential Ebola vaccines announced today by the NIH, that are being accelerated in response to the ongoing Ebola outbreak in west Africa that began in March and has since taken more than 1,500 lives. The NIH expects to report initial safety and efficacy data from the first study by the end of the calendar year, NIAID director Dr. Anthony Fauci, said today. When a proven and approved vaccine will be available remains a question, Fauci stressed. The phase one trials will be the first in a series of steps to test safety and potential effectiveness, before a vaccine can be administered outside of a closely monitored trial.

The product, and other versions of it that will be tested in studies that will follow in the fall, in England, Mali and Gambia, was suggested by earlier versions of a potential Ebola vaccine tested in 2003. It uses a type of chimpanzee cold virus to deliver material derived from two species of Ebola virus, including the species that is responsible for the current outbreak. An experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. also will begin human trials in the fall.

While the U.S. Food and Drug administration sped consideration of the product and trial design, safety measures will be typical — typically stringent — of those used for vaccine development, Fauci said. They will include daily and weekly reviews, including after the first three volunteers have received the vaccine next week, and before the next volunteers receive the product. The first study will enroll 20 healthy adults between the ages of 18 and 50.

The eventual product is intended primarily for people at high risk for infection, including health workers and people who work in laboratories in affected areas. But, Fauci emphasized, that public health measures, including isolation of sick patients, contact tracing, quarantines and protective equipment remain the focus of the response against the current outbreak.

“The vaccine will come as soon as we can get that vaccine in a safe and effective manner into people,” he said.

“We’ve really got to balance the compassionate need to get a product to people who need it,” he added, “with the need to make sure that we do what is scientifically and ethically sound.”

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