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

• ClinicalTrials.gov Identifier: NCT04170829
• Recruitment Status: Completed
• First Posted: November 20, 2019
• Last Update Posted: December 1, 2020
• Sponsor: King Abdullah International Medical Research Center
• Collaborator: University of Oxford
• Information provided by (Responsible Party): King Abdullah International Medical Research Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Middle East Respiratory Syndrome Coronavirus	Biological: ChAdOx1 MERS	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• 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
• Official Title: 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
• Actual Study Start Date: December 17, 2019
• Actual Primary Completion Date: November 26, 2020
• Actual Study Completion Date: November 26, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1 (n=6); will be administered ChAdOx1 MERS: 5 x 109 vp ChAdOx1 MERS	Biological: ChAdOx1 MERS; a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
Experimental: Group 2 (n=9); will be administered ChAdOx1 MERS: 2.5 x 1010 vp ChAdOx1 MERS	Biological: ChAdOx1 MERS; a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
Experimental: Group 3 (n=9); will be administered ChAdOx1 MERS: 5 x 1010 vp ChAdOx1 MERS	Biological: ChAdOx1 MERS; a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Saudi Arabia

King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, Saudi Arabia, 11426

Sponsors and Collaborators

King Abdullah International Medical Research Center

University of Oxford

Investigators

• Principal Investigator: Mohammad Bosaeed, MD; Ministry of National Guard-Health Affairs (MNGHA)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: King Abdullah International Medical Research Center
• ClinicalTrials.gov Identifier: NCT04170829
• Other Study ID Numbers: CT18/004/R; MERS002 ( Other Grant/Funding Number: University of Oxford )
• First Posted: November 20, 2019
• Last Update Posted: December 1, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King Abdullah International Medical Research Center:

MERS-CoV; ChAdOx1 MERS

Additional relevant MeSH terms:

Coronavirus Infections; Syndrome; Disease; Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections