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Ebola Vaccines Phase 2 Study Targets 1,500 Volunteers
By Joseph Toe, LINA
MONROVIA, March 27 (LINA) - A total of 1,500 persons will be enrolled in Phase 2 of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) study, according to the Liberian-US joint clinical research team.
The team noted that the number, which more than doubles the 600 participants that were enrolled in Phase 1, will also increase the percentage of women in the study.
The above is part of several initiatives being developed by the team in addition to exploring the possibility of sharing the Phase 3 of the PREFVAIL study with other countries within the West African sub-region.
Addressing the daily Ebola press briefing of the Ministry of Information at the ministry Thursday, co-principal investigator on the team, Dr. Stephen Kennedy, said at least two additional blood samples would be obtained from all participants for at least one year to examine the durability of the immune responses.
Kennedy pointed out that participants should continue be enrolled in the Phase 2 PREVAIL study at Redemption Hospital through late April and follow up with them for at least six to 12 months post-vaccination to determine the durability of the immune responses.
According to him, these proposed changes are being reviewed by the US Food and Drug Administration and Liberia and US Institutional Review Boards.
Kennedy pointed out that Phase 3 component of the study had planned to enroll about 27,000 Liberians at risk of the Ebola virus infection.
He noted, however, that as a result of Liberia’s successful infection control and prevention strategy targeting Ebola, there has been only one new case since February 19, prompting the team to decide it is scientifically appropriate to develop additional vaccine sites in other West African countries to consider co-sharing the Phase 3 study.
“Discussions are currently underway to explore that possibility,” he said.
It will be recalled the vaccines, ChAd3-EBO-Z, developed by GlaxoSmithKline or VSV-ZEBOV, from NewLink Genetics/Merck versus a saltwater placebo injection were introduced in the country early this year.