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Immune Durability After VSV-EBOV Vaccination

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ClinicalTrials.gov Identifier: NCT02933931
Recruitment Status : Active, not recruiting
First Posted : October 14, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Siegrist Claire-Anne, 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.

Condition or disease
Immune Response Vaccination Durability

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Immune Durability After Vaccination With the Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine (VSV-EBOV): a Prospective Observational Cohort Study
Actual Study Start Date : November 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. EBOV-specific IgG antibody titers measured by ELISA [ Time Frame: 5 years after vaccination ]

Secondary Outcome Measures :
  1. EBOV-specific IgG antibody titers measured by ELISA [ Time Frame: 2, 3, and 4 years after vaccination ]

Biospecimen Retention:   Samples Without DNA
whole blood (RNA preservation)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933931


Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Claire-Anne Siegrist, MD University of Geneva

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Siegrist Claire-Anne, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02933931     History of Changes
Other Study ID Numbers: 2016-00918
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs