Phase 1 Clinical Trial of Ebola Vaccine Passes Safety Test, Shows Good Immune Response

The Ebola epidemic has ravaged West Africa for more than a year now. Researchers are working on finding an effective vaccine against the deadly Ebola virus. A new study claimed that an experimental Ebola vaccine called VSV-EBOV appears safe and generates immune response in a small phase 1 clinical trial.

Scientists at the Public Health Agency of Canada's National Microbiology Laboratory originally developed the VSV-EBOV vaccine. The vaccine does not contain Ebola virus and cannot cause Ebola virus disease.

Two independent but coordinated studies, performed at the Walter Reed Army Institute of Research (WRAIR) and the National Institute of Allergy and Infectious Diseases (NIAID), explored the safety and immunogenicity of the Ebola vaccine when administered at different dosages. Lt. Col. Jason Regules, co-lead author of the study said, "These pivotal early studies helped inform dose selection for testing of VSV-EBOV vaccine in a large-scale clinical trial in West Africa. We were gratified to see that the vaccine was not associated with significant adverse effects in this very carefully monitored study."

During the trials, researchers collectively enrolled 52 volunteers who received either the vaccine candidate or a placebo. Volunteers who were given the vaccine received one of two different doses and volunteers were assessed on days 1, 3, 7, 14, and 28 to see if they developed anti-Ebola antibodies. The researchers found that 26 of 28 volunteers in the vaccine group showed the intended Ebola glycoprotein antibody response within two weeks of vaccination, and all of the volunteers had antibodies within 28 days of receiving the vaccine. Researchers saw a higher antibody response in the vaccine recipients who received the higher vaccine dose.

Col. Stephen Thomas, senior author of the study, said, "Researchers saw a robust immune response following a single dose of the vaccine, which could be particularly useful in outbreak interventions. We were able to leverage the WRAIR's experience in conducting ethical and safe clinical research experiments to meet a global need."

The study has been published in the New England Journal of Medicine.

Source: Medindia