An observational study in Immune Response, Vaccination and Durability, sponsored by University Hospital, Geneva. Completed. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by University Hospital, Geneva · Observational
This prospective observational cohort study will follow the roughly 100 adults who received the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in order to determine their long-term (5-year) immune response to vaccination.
Background: During the Ebola epidemic of 2014-5, there was no proven therapy or prevention available beyond horizontal infection control measures. After the Canadian government donated 800 vials of the vaccine candidate VSV-EBOV to World Health Organization (WHO), the University Hospitals of Geneva agreed to perform a WHO-coordinated phase I/II double-blind, placebo-controlled randomized trial to assess the candidate's safety and immunogenicity healthy adult volunteers. The doses of 10 E7 pfu and 5 x 10 E7 pfu were tested in 35 and 16 volunteers, respectively, before a safety-driven study hold in late 2014. At trial resumption in early 2015, the remaining volunteers (n=51) received 3 x 10 E5 pfu. Thirteen volunteers received placebo. Among vaccinees, early immune responses were impressive, even at the lowest dose of 3 x 10 E5 pfu, and persisted well up to 6 months (last time point assessed). The trial successfully ended 12 months after injection. This prospective observational study will assess immune durability in this group of vaccinees at yearly time points up to five years post-vaccination.
University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants are adults who were vaccinated according to the protocol of the Geneva phase I VSV-EBOV vaccine trial (NCT02287480) and who are willing and able to provide informed consent.
Exclusion Criteria:
Volunteers vaccinated in 2014 or 2015 with 5 x 10E7 pfu VSV-ZEBOV
Volunteers vaccinated in 2014 or 2015 with 10E7 pfu VSV-ZEBOV
Volunteers vaccinated in 2014 or 2015 with 3 x 10E5 pfu VSV-ZEBOV
EBOV-specific IgG antibody titers measured by ELISA
Time frame: 5 years after vaccination
EBOV-specific IgG antibody titers measured by ELISA
Time frame: 2, 3, and 4 years after vaccination
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva