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

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

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

Study Overview

• Status: Completed
• Conditions: Middle East Respiratory Syndrome Coronavirus
• Intervention / Treatment: Biological: ChAdOx1 MERS

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: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days following the vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6.5 months following completion of the vaccination regimen

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: University of Oxford
• Investigators: Principal Investigator: Mohammad Bosaeed, MD, Ministry of National Guard-Health Affairs (MNGHA)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 26, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 29, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: MERS-CoV; ChAdOx1 MERS
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease; Coronavirus Infections; Syndrome
• Other Study ID Numbers: CT18/004/R; MERS002 (Other Grant/Funding Number: University of Oxford)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No