Ebola Virus Disease Clinical Trial
— PRISMOfficial title:
Evaluating the Long Term Immunogenicity of Ebola Virus Vaccines Ad26-ZEBOV, MVA-BN-Filo and rVSV-ZEBOV
NCT number | NCT03140774 |
Other study ID # | OVG2016/04 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 17, 2017 |
Est. completion date | July 10, 2020 |
Verified date | December 2019 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 126 |
Est. completion date | July 10, 2020 |
Est. primary completion date | July 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. 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) 4. Agree to allow his or her General Practitioner and or Consultant if appropriate, to be notified of participation in the study, if required. Exclusion Criteria: 1. History of malignancy and receipt of immunosuppressive therapy 2. Post organ or stem cell transplantation with or without follow-on immunosuppressive therapy 3. 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) 4. Chronic or recurrent use of medication which modify host immune response 5. 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) 6. Any contraindication to venepuncture, as determined by clinical judgement |
Country | Name | City | State |
---|---|---|---|
United Kingdom | MRC - University of Glasgow Centre for Virus Research | Glasgow | |
United Kingdom | Oxford Vaccine Group, University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | University of Glasgow |
United Kingdom,
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. — View Citation
Winslow 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cellular Immunity by alternative method | Interferon-gamma (INF-gamma) release by Ebola GP specific activated T cells as measured by ELISpot | 24 to 60 months following the primary vaccination | |
Primary | Humoral Immunity | Binding antibody to the Ebola viral glycoprotein (GP) antigen assessed by ELISA | 24 to 60 months following the primary vaccination | |
Secondary | Cellular Immunity | Pro-inflammatory cytokine response of T cells, by using intracellular staining technique and multicolour flow cytometer | 24 to 60 months following the primary vaccination |
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