Immune Durability After VSV-EBOV Vaccination

May 25, 2021 updated by: Siegrist Claire-Anne, University Hospital, Geneva

Long-term Immune Durability After Vaccination With the Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine (VSV-EBOV): a Prospective Observational Cohort Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

95

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
vaccinated with 5 x 10E7 pfu VSV-ZEBOV
Volunteers vaccinated in 2014 or 2015 with 5 x 10E7 pfu VSV-ZEBOV
vaccinated with 10E7 pfu VSV-ZEBOV
Volunteers vaccinated in 2014 or 2015 with 10E7 pfu VSV-ZEBOV
vaccinated with 3 x 10E5 pfu VSV-ZEBOV
Volunteers vaccinated in 2014 or 2015 with 3 x 10E5 pfu VSV-ZEBOV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EBOV-specific IgG antibody titers measured by ELISA
Time Frame: 5 years after vaccination
5 years after vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
EBOV-specific IgG antibody titers measured by ELISA
Time Frame: 2, 3, and 4 years after vaccination
2, 3, and 4 years after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Claire-Anne Siegrist, MD, University of Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-00918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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