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CompletedNCT04170829Updated Dec 1, 2020

A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)

A Phase 1 interventional study of ChAdOx1 MERS in Middle East Respiratory Syndrome Coronavirus, sponsored by King Abdullah International Medical Research Center. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by King Abdullah International Medical Research Center · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
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Study summary

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

Read the detailed description

This is an open-label, dose escalation phase 1b trial to assess the safety and immunogenicity of the candidate ChAdOx1 MERS vaccine in healthy Middle Eastern adult volunteers aged 18-50. The first-in-human trial is now being conducted in Oxford in UK healthy adult volunteers. The vaccine will be administered intramuscularly.

Volunteers will be recruited and vaccinated at the King Abdulaziz Medical City, M-NGHA, Riyadh. There will be 3 study groups and a total of 24 volunteers will be enrolled. 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.

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Conditions studied

  • Middle East Respiratory Syndrome Coronavirus

Keywords

  • MERS-CoV
  • ChAdOx1 MERS
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 24 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

King Abdullah International Medical Research Center is the lead sponsor of 44 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy* ME 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 access the volunteer's medical history.
  4. 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
  5. Agreement to refrain from blood donation during the course of the study
  6. Provide written informed consent

Exclusion criteria

Exclusion Criteria:

  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.
  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 use.
  14. Suspected or known 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. History of exposure to MERS-CoV *
  20. 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.
  21. 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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Group 1 (n=6)

    will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS

    Biological: ChAdOx1 MERS

  • Experimental
    Group 2 (n=9)

    will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS

    Biological: ChAdOx1 MERS

  • Experimental
    Group 3 (n=9)

    will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS

    Biological: ChAdOx1 MERS

Interventions

  • BiologicalChAdOx1 MERS

    a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.

06

What researchers measure

Primary outcomes

  1. Occurrence of solicited and unsolicited local and systemic adverse events

    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: 28 days following the vaccination

Secondary outcomes

  1. Measures of immunogenicity to the ChAdOx1 MERS vaccine

    ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen

    Time frame: 6.5 months following completion of the vaccination regimen

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Study locations

1 site
  • King Abdulaziz Medical City, National Guard Health Affairs
    Riyadh, 11426, Saudi Arabia
08

References and documents

Publications

  • Bosaeed M, Balkhy HH, Almaziad S, Aljami HA, Alhatmi H, Alanazi H, Alahmadi M, Jawhary A, Alenazi MW, Almasoud A, Alanazi R, Bittaye M, Aboagye J, Albaalharith N, Batawi S, Folegatti P, Ramos Lopez F, Ewer K, Almoaikel K, Aljeraisy M, Alothman A, Gilbert SC, Khalaf Alharbi N. Safety and immunogenicity of ChAdOx1 MERS vaccine candidate in healthy Middle Eastern adults (MERS002): an open-label, non-randomised, dose-escalation, phase 1b trial. Lancet Microbe. 2022 Jan;3(1):e11-e20. doi: 10.1016/S2666-5247(21)00193-2. Epub 2021 Nov 3. PubMed 34751259 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04170829
Lead sponsor
King Abdullah International Medical Research Center
Collaborators
University of Oxford
Responsible party
Sponsor
First posted
Nov 20, 2019
Start date
Dec 17, 2019
Primary completion
Nov 26, 2020
Completion
Nov 26, 2020
Last update
Dec 1, 2020

Study contacts

Mohammad Bosaeed, MD
principal investigator · Ministry of National Guard-Health Affairs (MNGHA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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