Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001)
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ClinicalTrials.gov Identifier: NCT03399578 |
Recruitment Status :
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.)
First Posted : January 16, 2018
Last Update Posted : October 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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MERS (Middle East Respiratory Syndrome) | Biological: ChAdOx1 MERS | Phase 1 |
All vaccinations will be administered intramuscularly. In Groups 1-3, each volunteer will receive one vaccination in total. In Groups 4 and 5, each volunteer will receive two vaccinations in total.
There are five different vaccine schedules:
Group 1 (n=6) will receive 5 x 10^9 vp ChAdOx1 MERS .
Group 2 (n=9) will receive 2.5 x 10^10 vp ChAdOx1 MERS.
Group 3 (n=9) will receive 5 x 10^10 vp ChAdOx1 MERS.
Group 4 (n=6-12) will receive 2.5 x 10^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10^10 vp ChAdOx1 MERS at week 26.
Group 5 (n=6-12) will receive 2.5 x 10^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10^10 vp ChAdOx1 MERS at week 4.
The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.
Healthy adult volunteers will be recruited in Oxford, England.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | March 14, 2018 |
Actual Primary Completion Date : | September 17, 2021 |
Actual Study Completion Date : | September 17, 2021 |
Arm | Intervention/treatment |
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Experimental: Group 1
Group 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10^9 vp through intramuscular route.
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Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. |
Experimental: Group 2
Group 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp through intramuscular route.
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Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. |
Experimental: Group 3
Group 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10^10 vp through intramuscular route.
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Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. |
Experimental: 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. |
Experimental: 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.
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Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. |
- Occurrence of solicited and unsolicited local and systemic adverse events [ Time Frame: up to 28 days following 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
- Measures of immunogenicity to the ChAdOx1 MERS vaccine [ Time Frame: 12 months ]ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The volunteer must satisfy all the following criteria to be eligible for the study:
- Healthy 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 discuss the volunteer's medical history with their General Practitioner or access this medical history electronically.
- 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
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
- 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 (e.g. Adenovirus vectored vaccine).
- 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 abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting 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
- Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
- Prior exposure to MERS-CoV (serology will be requested at the discretion of the investigator)
- History of allergic reaction to Aminoglycoside antibiotics

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): NCT03399578
United Kingdom | |
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | |
Oxford, United Kingdom |
Principal Investigator: | Adrian V Hill, DPhil FRCP | Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom |
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT03399578 |
Other Study ID Numbers: |
MERS001 |
First Posted: | January 16, 2018 Key Record Dates |
Last Update Posted: | October 20, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus Infections Syndrome Disease Pathologic Processes Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Virus Diseases Infections |