Persistence of the Immune Response After Immunisation With Ebola Virus Vaccines
PRISM
Evaluating the Long Term Immunogenicity of Ebola Virus Vaccines Ad26-ZEBOV, MVA-BN-Filo and rVSV-ZEBOV
1 other identifier
observational
126
1 country
2
Brief Summary
The aim of this study is to investigate the persistence of the vaccine induced immune response between 24 - 60 months following primary vaccination. The study consists of three cohorts: Cohort 1: volunteers from the Phase 1 study of the various prime/boost regimes with two viral vectored Ebola vaccines: Ad26-ZEBOV and MVA-BN-Filo vaccines Cohort 2: volunteers who have been vaccinated previously with Ebola vaccine r-VSV-ZEBOV Cohort 3: volunteers from the Phase 2 study of 3 prime/boost regimes with Ad26.ZEBOV and MVA-BN-Filo vaccines (VAC52150EBL2001: EVOLVE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedStudy Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedJuly 15, 2020
December 1, 2019
3.2 years
May 2, 2017
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Humoral Immunity
Binding antibody to the Ebola viral glycoprotein (GP) antigen assessed by ELISA
24 to 60 months following the primary vaccination
Secondary Outcomes (1)
Cellular Immunity
24 to 60 months following the primary vaccination
Other Outcomes (1)
Cellular Immunity by alternative method
24 to 60 months following the primary vaccination
Study Arms (3)
Cohort 1: Phase 1 participants
Previously exposed to Ebola vaccine Ad26-ZEBOV and MVA-BN-Filo.
Cohort 2: Received r-VSV-ZEBOV vaccine
Previously exposed to Ebola vaccine rVSV-EBOV.
Cohort 3: Phase 2 participants
Previously exposed to Ebola vaccine Ad26-ZEBOV and MVA-BN-Filo
Interventions
Exposure of interest: participants must have had one or more previous Ebola vaccines, Ad26.ZEBOV , MVA-BN-Filo or r-VSV-ZEBOV to enter the study.
Eligibility Criteria
Cohort 1: 56 Phase 1 study participants who have received both Ad26-ZEBOV and the MVA-BN-Filo vaccines and who meet the inclusion and exclusion criteria as listed above . Cohort 2: 26 participants who received r-VSV-ZEBOV vaccine as a part of clinical preventative care. Cohort 3: 148 Phase 2 study participants who have received both Ad26-ZEBOV and the MVA-BN-Filo vaccines and who meet the inclusion and exclusion criteria as listed above
You may qualify if:
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
- Subject must have received both vaccines in the phase 1 trial (Cohort 1) the r-VSV-ZEBOV vaccine (Cohort 2), or both vaccines in the Phase 2 trial (Cohort 3)
- Agree to allow his or her General Practitioner and or Consultant if appropriate, to be notified of participation in the study, if required.
You may not qualify if:
- History of malignancy and receipt of immunosuppressive therapy
- Post organ or stem cell transplantation with or without follow-on immunosuppressive therapy
- Receipt of adeno virus or MVA virus based vaccine since the Phase 1 or Phase 2 study (Cohort 1 and 3) or since receiving the r-VSV-ZEBOV vaccine (Cohort 2)
- Chronic or recurrent use of medication which modify host immune response
- A visit to an Ebola endemic area since the Phase 1 or Phase 2 study (Cohort 1 and 3) or since receiving the r-VSV-ZEBOV vaccine (Cohort 2)
- Any contraindication to venepuncture, as determined by clinical judgement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- University of Glasgowcollaborator
Study Sites (2)
MRC - University of Glasgow Centre for Virus Research
Glasgow, G61 1QH, United Kingdom
Oxford Vaccine Group, University of Oxford
Oxford, OX3 7LJ, United Kingdom
Related Publications (2)
Milligan ID, Gibani MM, Sewell R, Clutterbuck EA, Campbell D, Plested E, Nuthall E, Voysey M, Silva-Reyes L, McElrath MJ, De Rosa SC, Frahm N, Cohen KW, Shukarev G, Orzabal N, van Duijnhoven W, Truyers C, Bachmayer N, Splinter D, Samy N, Pau MG, Schuitemaker H, Luhn K, Callendret B, Van Hoof J, Douoguih M, Ewer K, Angus B, Pollard AJ, Snape MD. Safety and Immunogenicity of Novel Adenovirus Type 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1610-23. doi: 10.1001/jama.2016.4218.
PMID: 27092831BACKGROUNDWinslow RL, Milligan ID, Voysey M, Luhn K, Shukarev G, Douoguih M, Snape MD. Immune Responses to Novel Adenovirus Type 26 and Modified Vaccinia Virus Ankara-Vectored Ebola Vaccines at 1 Year. JAMA. 2017 Mar 14;317(10):1075-1077. doi: 10.1001/jama.2016.20644. No abstract available.
PMID: 28291882BACKGROUND
Related Links
Biospecimen
We will seek consent for storage of excess blood samples in the Biobank. Participants will be separately consented for this.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Snape, FRCPH, MD
Oxford Vaccine Group, University of Oxford
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 4, 2017
Study Start
May 17, 2017
Primary Completion
July 10, 2020
Study Completion
July 10, 2020
Last Updated
July 15, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share