Immune Durability After VSV-EBOV Vaccination
Study Details
Study Description
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 | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| vaccinated with 5 x 10E7 pfu VSV-ZEBOV Volunteers vaccinated in 2014 or 2015 with 5 x 10E7 pfu VSV-ZEBOV |
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| vaccinated with 10E7 pfu VSV-ZEBOV Volunteers vaccinated in 2014 or 2015 with 10E7 pfu VSV-ZEBOV |
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| vaccinated with 3 x 10E5 pfu VSV-ZEBOV Volunteers vaccinated in 2014 or 2015 with 3 x 10E5 pfu VSV-ZEBOV |
Outcome Measures
Primary Outcome Measures
- EBOV-specific IgG antibody titers measured by ELISA [5 years after vaccination]
Secondary Outcome Measures
- EBOV-specific IgG antibody titers measured by ELISA [2, 3, and 4 years after vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Able to provide written, informed consent for this observational study.
Exclusion Criteria:
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Received additional vaccination with VSV-EBOV at similar or differing doses.
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Was lost to follow-up in the Geneva phase I VSV-EBOV vaccine trial
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Geneva
Investigators
- Principal Investigator: Claire-Anne Siegrist, MD, University of Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
- 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, Lemaître B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmüller 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.
- Huttner A, Dayer JA, Yerly S, Combescure C, Auderset F, Desmeules J, Eickmann M, Finckh A, Goncalves AR, Hooper JW, Kaya G, Krähling V, Kwilas S, Lemaître 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.
- 2016-00918