Immune response seen in all study volunteers; side effects were manageable
THURSDAY, April 2, 2015 (HealthDay News) — Two separate teams of investigators conclude that an experimental Ebola vaccine is safe, with side effects confined to fever, fatigue, injection-site pain, and/or joint pain. The reports on what is known as the recombinant vesicular stomatitis virus (rVSV) vaccine were published online April 1 in the New England Journal of Medicine.
Jason Regules, M.D., from the Walter Reed Army Institute of Research in Silver Springs, Md., and colleagues conducted two phase 1 trials (funded in part by the U.S. National Institutes of Health) involving just 52 participants who were broken down into groups of 13. In each group, three participants were injected once with a dummy vaccine, while 10 received either a low dose or high dose of the new rVSV vaccine. By the end of a 28-day study period, the team found that those who got the vaccine had safely developed immune responses, with more antibodies generated among the high-dose participants.
Claire-Anne Siegrist, M.D., of the Center for Vaccinology at Geneva University Hospitals, and colleagues conducted three phase 1 trials involving a total of 158 participants located in both Europe and Africa. All the participants were injected with the same rVSV vaccine, but at different doses. Roughly a third of the patients developed a short-lived fever, while about a fifth developed joint arthritis. Antibody responses were observed in all vaccine groups.
Both teams concluded that the results call for more testing of the vaccine.
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