The United States health officials have said they are considering a trial test of the recently launched Ebola vaccine in Nigeria, as they also prepare to test the vaccine in The Gambia and Mali in mid-September.
The US National Institutes of Health announced in a statement on Thursday that it would launch the safety trial on the vaccine developed by the agency’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline.
The testing is expected to start on Tuesday with 20 volunteers to see if the virus is safe for use on humans.
The statement said in part, “The US Centres for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country. The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing Ebola virus outbreak in West Africa.”
Testing of the vaccine will be at NIH’s campus and involve a mixture that uses both the current Zaire strain and another strain, Sudan. In the second week of September, NIH and a British team will test that vaccine on 100 volunteers in the United Kingdom.
“Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
“The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland,” the NIH noted.
The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada.
According to the statement, these trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.
“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” the NIAID Director, Anthony Fauci, said.
He added, “We know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment.
“However, a vaccine will ultimately be an important tool in the prevention effort. The launch of Phase 1 Ebola vaccine studies is the first step in a long process.” Agency report
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