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NIH to launch human trials of Ebola vaccine

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Human testing of an investigational bivalent Ebola vaccine will commence next week, according to the NIH. Its development has been expedited in response to the outbreak currently spreading in West Africa.

The study will be the first in a series that will examine the vaccine’s safety and immunogenicity in healthy adults. The vaccine was co-developed by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. The NIH also has partnered with the Public Health Agency of Canada to test another Ebola vaccine candidate, which is licensed to NewLink Genetics Corp. Those trials are expected to commence in the fall.

“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,” NIAID Director Anthony S. Fauci, MD, said in a news release. “The NIH is playing a key role in accelerating the development and testing of investigational Ebola vaccines.”

 

Anthony S. Fauci

The phase 1 trial of the NIH/GSK bivalent vaccine will take place at the NIH Clinical Center in Bethesda, Md. The vaccine also will be tested in healthy volunteers in the United Kingdom and Mali, and the NIH aims to test the vaccine in Gambia after approval from authorities there.

However, vaccine development is only part of the response to the threat of Ebola, according CDC Director Thomas R. Frieden, MD, MPH.

“Tried and true public health interventions, strong supportive medical care and the rapid testing of Ebola vaccines and antiviral treatments can help to reduce suffering now and in the future,” he said.

 

Thomas R. Frieden

The NIH/GSK vaccine was designed by Nancy J. Sullivan, PhD, chief of the biodefense research section at the NIAID’s Vaccine Research Center (VRC), in collaboration with the US Army Medical Research Institute of Infectious Diseases, and Okairos, a subsidiary of GlaxoSmithKline. According to the NIH, the vaccine is based on a chimp adenovirus, which will deliver two of the five species of Ebola virus — Zaire ebolavirus and Sudan ebolavirus. The Zaire strain is responsible for the West African outbreak, the largest ever documented.

The vaccine candidate is based on three earlier NIAID vaccines. According to Fauci, it had performed well in animal studies.

“The knowledge gained from each of those trials has contributed to the development of the candidate vaccine we are now studying, as well as our improved understanding of human immune responses to investigational Ebola vaccines,” said John R. Mascola, MD, director of the NIAID’s VCR.

Julie E. Ledgerwood, DO, chief of the clinical trials program at the VRC, will lead the phase 1 trial, which will include 20 adults aged 18 to 50 years. One group will receive an intramuscular injection of the vaccine while the other will receive a single injection at a higher dose. Participants will be followed up for 48 weeks.

 

Julie E. Ledgerwood

Beginning in October, a portion of the phase 1 trial will be dedicated to testing a version of the vaccine containing only the Zaire strain in 20 healthy adults. The monovalent vaccine also will be tested in 60 adults in the United Kingdom at the University of Oxford and in 40 healthy volunteers in Mali. It also may be tested in another cohort in Gambia. The Oxford trial is expected to launch in mid-September.

“Today’s announcement shows how private and public partners can pull together to quickly respond to this critical public health emergency,” Moncef Slaoui, PhD, chairman of global research and development at GlaxoSmithKline, said in the release. “Developing a vaccine is complex with no guarantees of success, and we are still in the early days for our Ebola vaccine candidate. But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to this or future Ebola outbreaks.”

Results from the phase 1 trial are expected in late 2014.