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Ebola prime-boost vaccine regimen undergoes testing
Johnson & Johnson recently launched a trial assessing the safety and immunogenicity of an Ebola prime-boost vaccine regimen, according to a press release.
The open-label EBOVAC-Salone trial, coordinated by researchers from the London School of Hygiene & Tropical Medicine, will enroll adults, adolescents and children, including those with HIV, within the general population of Sierra Leone’s Kambia district.
Approximately 40 adults will be enrolled during the first stage of the trial, according to the release. The participants will receive 0.5 mL of Ad26.ZEBOV (Johnson & Johnson), followed by a 0.5mL IM booster of MVA-BN-Filo (Bavarian Nordic) 2 months after the first dose. Safety data will be collected 7 days after each vaccination and reviewed by an independent monitoring committee. The committee then will decide whether the vaccine regimen can be safely administered to 400 participants aged 1 year or older during the second stage of the trial. All of the patients will be followed for 1 year after the initial vaccination.
Janssen Pharmaceuticals, a Johnson & Johnson company, also is collaborating with Bavarian Nordic to rapidly produce more than 800,000 regimens, with the capacity to produce up to 2 million regimens as needed. A division of Janssen Pharmaceuticals received $28.5 million from the Department of Health and Human Services in September to accelerate the development of the prime-boost vaccine regimen, according to the release.
“We urgently need a vaccine that offers long-term protection of the population, including health workers and other caregivers, in order to prevent a resurgence of the virus,” Peter Piot, MD, PhD, director of the London School of Hygiene & Tropical Medicine, said in the release. “To achieve this goal, it is vital to test a range of vaccine candidates, particularly in the areas affected by the epidemic where we are still seeing new cases emerging, and there is evidence that the infection may have longer-term effects among survivors.
Peter Piot
“Prime-boost vaccination is an effective strategy for long-term prevention of several infectious diseases, and we believe it may have a key role to play in the fight against Ebola."
The EBOVAC-Salone study is supported through partnerships with Sierra Leone’s Ministry of Health and Sanitation, the College of Medicine and Allied Health Sciences, and other companies and research institutions, as well as consortia funded by Europe’s Innovative Medicines Initiative.
Multiple phase 3 trials are being conducted across the United States, Europe and Africa as part of the accelerated vaccine development plan, according to the release. In July, interim results of a phase 3 trial evaluating the rVSV-ZOBOV (NewLink Genetics, Merck) vaccine developed by the Public Health Agency of Canada demonstrated 100% efficacy in more than 4,000 adults in Guinea. Another vaccine candidate co-developed by the NIH and a GlaxoSmithKline subsidiary, chimpanzee adenovirus 3 (ChAd3), appeared safe and immunogenic in early trials.
As of October 16, there have been 28,468 cases of Ebola virus disease in Sierra Leone, Guinea and Liberia, with 11,298 deaths, including more than 500 health care workers, according to WHO.
Disclosures: Piot reports no relevant financial disclosures.
Editor’s Note: This article was updated on Oct. 19 to clarify the stage of the trial for the Ebola prime-boost vaccine regimen. The Editors regret this error.
Photo credit: Heidi Larson