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Trial record 1 of 1 for:    chadox1 | MERS (Middle East Respiratory Syndrome) | Saudi Arabia
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A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04170829
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

Tracking Information
First Submitted Date  ICMJE November 14, 2019
First Posted Date  ICMJE November 20, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE December 17, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)
Official Title  ICMJE 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
Brief 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial
Masking: None (Open Label)
Masking Description:
Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial
Primary Purpose: Prevention
Condition  ICMJE Middle East Respiratory Syndrome Coronavirus
Intervention  ICMJE Biological: ChAdOx1 MERS
a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
Study Arms  ICMJE
  • Experimental: Group 1 (n=6)
    will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS
    Intervention: Biological: ChAdOx1 MERS
  • Experimental: Group 2 (n=9)
    will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS
    Intervention: Biological: ChAdOx1 MERS
  • Experimental: Group 3 (n=9)
    will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS
    Intervention: Biological: ChAdOx1 MERS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Majed Al Jeraisy, M.Sc. 0096611 849 4455 ext 94455 JeraisyM@NGHA.MED.SA
Contact: Naif Alharbi, PHD 0096611 849 4455 ext 94552 harbina2@ngha.med.sa
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04170829
Other Study ID Numbers  ICMJE CT18/004/R
MERS002 ( Other Grant/Funding Number: University of Oxford )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party King Abdullah International Medical Research Center
Study Sponsor  ICMJE King Abdullah International Medical Research Center
Collaborators  ICMJE University of Oxford
Investigators  ICMJE
Principal Investigator: Mohammad Bosaeed, MD Ministry of National Guard-Health Affairs (MNGHA)
PRS Account King Abdullah International Medical Research Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP