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Persistence of the Immune Response After Immunisation With Ebola Virus Vaccines (PRISM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03140774
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
University of Oxford

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).


Condition or disease Intervention/treatment
Ebola Virus Disease Biological: Previously exposed to Ebola vaccine

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Long Term Immunogenicity of Ebola Virus Vaccines Ad26-ZEBOV, MVA-BN-Filo and rVSV-ZEBOV
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Group/Cohort Intervention/treatment
Cohort 1: Phase 1 participants
Previously exposed to Ebola vaccine Ad26-ZEBOV and MVA-BN-Filo.
Biological: Previously exposed to Ebola vaccine
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.

Cohort 2: Received r-VSV-ZEBOV vaccine
Previously exposed to Ebola vaccine rVSV-EBOV.
Biological: Previously exposed to Ebola vaccine
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.

Cohort 3: Phase 2 participants
Previously exposed to Ebola vaccine Ad26-ZEBOV and MVA-BN-Filo
Biological: Previously exposed to Ebola vaccine
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.




Primary Outcome Measures :
  1. Humoral Immunity [ Time Frame: 24 to 60 months following the primary vaccination ]
    Binding antibody to the Ebola viral glycoprotein (GP) antigen assessed by ELISA


Secondary Outcome Measures :
  1. Cellular Immunity [ Time Frame: 24 to 60 months following the primary vaccination ]
    Pro-inflammatory cytokine response of T cells, by using intracellular staining technique and multicolour flow cytometer


Other Outcome Measures:
  1. Cellular Immunity by alternative method [ Time Frame: 24 to 60 months following the primary vaccination ]
    Interferon-gamma (INF-gamma) release by Ebola GP specific activated T cells as measured by ELISpot


Biospecimen Retention:   Samples With DNA
We will seek consent for storage of excess blood samples in the Biobank. Participants will be separately consented for this.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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

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): NCT03140774


Locations
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United Kingdom
MRC - University of Glasgow Centre for Virus Research
Glasgow, United Kingdom, G61 1QH
Oxford Vaccine Group, University of Oxford
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
University of Glasgow
Investigators
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Principal Investigator: Matthew Snape, FRCPH, MD Oxford Vaccine Group, University of Oxford
Additional Information:
Publications:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03140774    
Other Study ID Numbers: OVG2016/04
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Ebola vaccine
immunogenicity
persistence
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections