Immune Durability After VSV-EBOV Vaccination

Completed

• Conditions: Durability; Immune Response; Vaccination

• Registration Number: NCT02933931
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Study Start: 2016-11
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Participated and was vaccinated with a single injection of VSV-EBOV at a dose of either 3 x 10E5 pfu, 10E7 pfu or 5 x 10E7 pfu in the Geneva phase I VSV-EBOV vaccine trial (NCT02287480).
• Able to provide written, informed consent for this observational study.

Exclusion Criteria

• Received additional vaccination with VSV-EBOV at similar or differing doses.
• Was lost to follow-up in the Geneva phase I VSV-EBOV vaccine trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EBOV-specific IgG antibody titers measured by ELISA	5 years after vaccination

Secondary Outcome Measures

Name	Time	Method
EBOV-specific IgG antibody titers measured by ELISA	2, 3, and 4 years after vaccination