NCT02933931

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

October 11, 2016

Last Update Submit

May 25, 2021

Conditions

Immune ResponseVaccinationDurability

Outcome Measures

Primary Outcomes (1)

  • EBOV-specific IgG antibody titers measured by ELISA

    5 years after vaccination

Secondary Outcomes (1)

  • EBOV-specific IgG antibody titers measured by ELISA

    2, 3, and 4 years after vaccination

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaitre B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmuller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Epub 2015 Apr 1.

    PMID: 25830326BACKGROUND

  • Huttner A, Dayer JA, Yerly S, Combescure C, Auderset F, Desmeules J, Eickmann M, Finckh A, Goncalves AR, Hooper JW, Kaya G, Krahling V, Kwilas S, Lemaitre B, Matthey A, Silvera P, Becker S, Fast PE, Moorthy V, Kieny MP, Kaiser L, Siegrist CA; VSV-Ebola Consortium. The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2015 Oct;15(10):1156-1166. doi: 10.1016/S1473-3099(15)00154-1. Epub 2015 Aug 4.

    PMID: 26248510BACKGROUND

  • Huttner A, Agnandji ST, Combescure C, Fernandes JF, Bache EB, Kabwende L, Ndungu FM, Brosnahan J, Monath TP, Lemaitre B, Grillet S, Botto M, Engler O, Portmann J, Siegrist D, Bejon P, Silvera P, Kremsner P, Siegrist CA; VEBCON; VSV-EBOVAC; VSV-EBOPLUS Consortia. Determinants of antibody persistence across doses and continents after single-dose rVSV-ZEBOV vaccination for Ebola virus disease: an observational cohort study. Lancet Infect Dis. 2018 Jul;18(7):738-748. doi: 10.1016/S1473-3099(18)30165-8. Epub 2018 Apr 5.

    PMID: 29627147DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood (RNA preservation)

Study Officials

  • Claire-Anne Siegrist, MD

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 14, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share