A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers
Latest Information Update: 21 Oct 2021
At a glance
- Drugs Middle East respiratory syndrome coronavirus vaccine - Vaccitech (Primary)
- Indications Middle East respiratory syndrome coronavirus
- Focus Adverse reactions; First in man
- 12 Oct 2021 Status changed from suspended to discontinued.
- 14 Apr 2021 Planned End Date changed from 1 Jul 2021 to 1 Sep 2022.
- 14 Apr 2021 Planned primary completion date changed from 1 Jul 2021 to 1 Sep 2022.
Most Recent Events
Trial Overview
Purpose
This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.
Comments
Reason the study was terminated : The scientific questions proposed remain relevant, but will now be addressed in a larger phase II immunogenicity trial of the ChAdOx1 MERS vaccine given at 2 doses.
According to the clinicaltrial.gov record, the SARS-CoV-2 pandemic delayed recruitment for but also provided an opportunity to apply findings from the rapid development of a ChAdOx1-vectored vaccine against SARS-CoV-2 to the further development of the MERS vaccine.
Primary Endpoints
Occurrence of solicited and unsolicited local and systemic adverse events
description: The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration
time_frame: up to 28 days following vaccination
Other Endpoints
Measures of immunogenicity to the ChAdOx1 MERS vaccine
description: ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen
time_frame: 12 months [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
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Middle East respiratory syndrome coronavirus | prevention | - |
Subjects
- Subject Type patients
-
Number
Planned: 48
Actual: 29
- Sex male & female
- Age Group 18-50 years; adult
Patient Inclusion Criteria
The volunteer must satisfy all the following criteria to be eligible for the study: 1. Healthy adults aged 18 to 50 years 2. Able and willing (in the Investigator's opinion) to comply with all study requirements 3. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner or access this medical history electronically. 4. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination 5. Agreement to refrain from blood donation during the course of the study 6. Provide written informed consent
Patient Exclusion Criteria
The volunteer may not enter the study if any of the following apply: 1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period 2. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine). 3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 4. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) 5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine 6. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 7. Any history of anaphylaxis in relation to vaccination 8. Pregnancy, lactation or willingness/intention to become pregnant during the study 9. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 10. History of serious psychiatric condition likely to affect participation in the study 11. Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 12. Any other serious chronic illness requiring hospital specialist supervision 13. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week 14. Suspected or known injecting drug abuse in the 5 years preceding enrolment 15. Seropositive for hepatitis B surface antigen (HBsAg) 16. Seropositive for hepatitis C virus (antibodies to HCV) 17. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis 18. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data 19. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate 20. Prior exposure to MERS-CoV (serology will be requested at the discretion of the investigator) 21. History of allergic reaction to Aminoglycoside antibiotics
Trial Details
Identifiers
Identifier | Owner |
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NCT03399578 | ClinicalTrials.gov: US National Institutes of Health |
MERS001 | - |
Organisations
- Affiliations Barinthus Biotherapeutics
Trial Dates
-
Initiation Dates
Planned : 01 Jan 2018
Actual : 14 Mar 2018
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Primary Completion Dates
Planned : 01 Sep 2022
Actual : 17 Sep 2021
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End Dates
Planned : 01 Sep 2022
Actual : 17 Sep 2021
Other Details
- Design open; parallel; prospective
- Phase of Trial Phase I
- Location England
- Focus Adverse reactions; First in man
Interventions
Drugs | Route | Formulation |
---|---|---|
Middle East respiratory syndrome coronavirus vaccine - VaccitechPrimary Drug | Intramuscular | Injection |
Group 1
Group 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10^9 vp through intramuscular route. Biological: ChAdOx1 MERS (The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.)
Group 2
Group 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp through intramuscular route. Biological: ChAdOx1 MERS (The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.)
Group 3
Group 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10^10 vp through intramuscular route. Biological: ChAdOx1 MERS (The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.)
Group 4
Group 4 volunteers (n=6-12) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp at week 0, followed by ChAdOx1 MERS, 2.5 x 10^10 vp at week 26. Both administrations will be given through intramuscular route. Biological: ChAdOx1 MERS (The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.)
Group 5
Group 5 volunteers (n=6-12) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp at week 0, followed by ChAdOx1 MERS, 2.5 x 10^10 vp at week 4. Both administrations will be given through intramuscular route. Biological: ChAdOx1 MERS (The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.)
Results
Publications
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Folegatti PM, Bittaye M, Flaxman A, Lopez FR, Bellamy D, Kupke A, et al. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial. Lancet-Infect-Dis 2020;20(7):816-826.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Adrian Hill, DPhil FRCP
vaccinetrials@ndm.ox.ac.uk
show details
|
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | United-Kingdom |
Adrian V Hill, DPhil FRCP
vaccinetrials@ndm.ox.ac.uk
show details
|
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom | United-Kingdom |
Volunteer Coordinator
01865 611424 vaccinetrials@ndm.ox.ac.uk
show details
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Centres
Centre Name | Location | Trial Centre Country |
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- |
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Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | Oxford | United-Kingdom |
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | Oxford | United-Kingdom |
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom |
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University of Oxford
Volunteer Coordinator
show details
01865 611424 vaccinetrials@ndm.ox.ac.uk |
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Trial History
Event Date | Event Type | Comment |
---|---|---|
21 Oct 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 21 Oct 2021 |
12 Oct 2021 | Status change - discontinued | Status changed from suspended to discontinued. Updated 21 Oct 2021 |
14 Apr 2021 | Completion date | Planned End Date changed from 1 Jul 2021 to 1 Sep 2022. Updated 20 Apr 2021 |
14 Apr 2021 | Other trial event | Planned primary completion date changed from 1 Jul 2021 to 1 Sep 2022. Updated 20 Apr 2021 |
14 Apr 2021 | Status change - suspended | Status changed from recruiting to suspended due to the SARS-CoV-2 pandemic. Updated 20 Apr 2021 |
01 Jul 2020 | Results | Results (n=24) assessing the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans published in The Lancet Infectious Diseases Updated 21 Sep 2020 |
18 Oct 2019 | Other trial event | Planned number of patients changed from 24 to 48. Updated 23 Oct 2019 |
18 Oct 2019 | Completion date | Planned End Date changed from 1 Dec 2019 to 1 Jul 2021. Updated 23 Oct 2019 |
18 Oct 2019 | Other trial event | Planned primary completion date changed from 1 Dec 2019 to 1 Jul 2021. Updated 23 Oct 2019 |
09 May 2019 | Completion date | Planned End Date changed from 1 Mar 2019 to 1 Dec 2019. Updated 14 May 2019 |
09 May 2019 | Other trial event | Planned primary completion date changed from 1 Mar 2019 to 1 Dec 2019. Updated 14 May 2019 |
10 Apr 2018 | Completion date | Planned End Date changed from 1 Jan 2019 to 1 Mar 2019. Updated 13 Apr 2018 |
10 Apr 2018 | Other trial event | Planned primary completion date changed from 1 Jan 2019 to 1 Mar 2019. Updated 13 Apr 2018 |
10 Apr 2018 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 13 Apr 2018 |
22 Jan 2018 | New trial record | New trial record Updated 22 Jan 2018 |
Table of Contents
References
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Folegatti PM, Bittaye M, Flaxman A, Lopez FR, Bellamy D, Kupke A, et al. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial. Lancet-Infect-Dis 2020;20(7):816-826.
PubMed | CrossRef Fulltext -
ProBioGen. ProBioGen and Vaccitech Sign License Agreement for ProBioGens Technology Platform. Media-Rel 2019;.
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