A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers
Latest Information Update: 08 Jan 2024
At a glance
- Drugs Middle East respiratory syndrome coronavirus vaccine - Vaccitech (Primary)
- Indications Middle East respiratory syndrome coronavirus
- Focus Adverse reactions; First in man
- 04 Nov 2021 According to Vaccitech media release, this trial is part of a collaboration between the University of Oxford's Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC).
- 04 Nov 2021 According to Vaccitech media release, results from this trial were published in The Lancet Microbe.
- 04 Nov 2021 Results published in the Vaccitech Media Release.
Most Recent Events
Trial Overview
Purpose
Phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers.
Primary Endpoints
Occurrence of solicited and unsolicited local and systemic adverse events
[ Time Frame: 28 days following the vaccination ]
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
Other Endpoints
Measures of immunogenicity to the ChAdOx1 MERS vaccine
[ Time Frame: 6.5 months following completion of the vaccination regimen ]
ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Middle East respiratory syndrome coronavirus | prevention | - |
Subjects
- Subject Type patients
-
Number
Planned: 24
- Sex male & female
Patient Inclusion Criteria
Healthy* ME adults aged 18 to 50 years
Able and willing (in the Investigator's opinion) to comply with all study requirements
Willing to allow the investigators to access the volunteer's medical history.
For females only, not planning to get pregnant during the study and a negative pregnancy test on the day(s) of screening and vaccination. Effective methods of contraception must be used. See section 6.3.3
Agreement to refrain from blood donation during the course of the study
Provide written informed consent
Patient Exclusion Criteria
Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
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)
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
Any history of anaphylaxis in relation to vaccination
Pregnancy, lactation or willingness/intention to become pregnant during the study
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
History of serious psychiatric condition likely to affect participation in the study
Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
Any other serious chronic illness requiring hospital specialist supervision
Suspected or known current alcohol use.
Suspected or known drug abuse in the 5 years preceding enrolment
Seropositive for hepatitis B surface antigen (HBsAg)
Seropositive for hepatitis C virus (antibodies to HCV)
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
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
History of exposure to MERS-CoV *
History of contact with camels. Defined as working in farms or barns; having been within 6 feet (2 meters) of a sick camel without PPE; or consumption of raw milk or uncooked meat. For this study, 30 days prior to screening will be considered.
History of allergic reaction to Aminoglycoside antibiotics. *rRT-PCR testing of nasopharyngeal specimen , at the discretion of PI, may be indicated when a volunteer is suspected to be asymptomatic carrier.
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04170829 | ClinicalTrials.gov: US National Institutes of Health |
CT18-004R | - |
MERS002 | - |
Organisations
- Affiliations Barinthus Biotherapeutics; Vaccitech
Trial Dates
-
Initiation Dates
Actual : 17 Dec 2019
-
Primary Completion Dates
Actual : 26 Nov 2020
-
End Dates
Actual : 26 Nov 2020
Other Details
- Design open; parallel; prospective
- Phase of Trial Phase I
- Location Saudi Arabia
- Focus Adverse reactions; First in man
Interventions
Drugs | Route | Formulation |
---|---|---|
Middle East respiratory syndrome coronavirus vaccine - VaccitechPrimary Drug | Intramuscular |
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|
There will be 3 study groups. Staggered enrolment will apply for the first three volunteers within each group. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be allocated to a study group by selecting eligible volunteers for enrolment in the order in which they were deemed eligible, following screening.
Experimental: Group 1 (n=6)
will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS
Experimental: Group 2 (n=9)
will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS
Experimental: Group 3 (n=9)
will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS
Results
Publications
-
Vaccitech. Vaccitech Announces Publication of Second Phase 1 Clinical Trial Results of ChAdOx1 Vaccine in Development for the MERS Coronavirus. Media-Rel 2021;.
Media Release
Trial Centres
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
King Abdullah International Medical Research Center |
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|
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Trial History
Event Date | Event Type | Comment |
---|---|---|
06 Nov 2023 | Other trial event | According to Barinthus Biotherapeutics media release, Vaccitech has changed its name to Barinthus Biotherapeutics Updated 08 Jan 2024 |
04 Nov 2021 | Other trial event | According to Vaccitech media release, this trial is part of a collaboration between the University of Oxford's Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC). Updated 16 Nov 2021 |
04 Nov 2021 | Other trial event | According to Vaccitech media release, results from this trial were published in The Lancet Microbe. Updated 16 Nov 2021 |
04 Nov 2021 | Results | Results published in the Vaccitech Media Release. Updated 16 Nov 2021 |
30 Dec 2019 | New trial record | New trial record Updated 30 Dec 2019 |
20 Dec 2019 | Other trial event | According to Vaccitech media release, Naif Alharbi, vaccinologist is Co-PI on the Saudi MERS vaccine trial. Updated 30 Dec 2019 |
20 Dec 2019 | Other trial event | According to Vaccitech media release, trial will take place in King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC), both are under the Ministry of National Guard Health Affairs (Saudi NGHA) Updated 30 Dec 2019 |
References
-
Vaccitech. New MERS vaccine clinical trial starts in Saudi Arabia. Media-Rel 2019;.
Media Release -
Vaccitech. Vaccitech Announces Publication of Second Phase 1 Clinical Trial Results of ChAdOx1 Vaccine in Development for the MERS Coronavirus. Media-Rel 2021;.
Media Release -
Barinthus Biotherapeutics plc. Vaccitech Renames as Barinthus Biotherapeutics to Highlight Strategic Evolution into a T Cell Immunotherapy Company Targeting Chronic Infectious Diseases, Autoimmunity, and Cancer . Media-Rel 2023;.
Media Release
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