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

NCT04170829 | Completed Phase 1

• 2 other identifiers: CT18/004/RMERS002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Middle East Respiratory Syndrome Coronavirus

Keywords

MERS-CoV; ChAdOx1 MERS

Outcome Measures

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

  28 days following the vaccination

Secondary Outcomes (1)

• Measures of immunogenicity to the ChAdOx1 MERS vaccine

  6.5 months following completion of the vaccination regimen

Study Arms (3)

Group 1 (n=6)

EXPERIMENTAL

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

Biological: ChAdOx1 MERS

Group 2 (n=9)

EXPERIMENTAL

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

Biological: ChAdOx1 MERS

Group 3 (n=9)

EXPERIMENTAL

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

Biological: ChAdOx1 MERS

Interventions

ChAdOx1 MERS BIOLOGICAL

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

Group 1 (n=6); Group 2 (n=9); Group 3 (n=9)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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 use.
• Suspected or known drug abuse in the 5 years preceding enrolment
• Seropositive for hepatitis B surface antigen (HBsAg)

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• University of Oxford: collaborator

Study Sites (1)

King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 34751259 DERIVED

MeSH Terms

Interventions

Middle East respiratory syndrome vaccine

Study Officials

• Mohammad Bosaeed, MD

  Ministry of National Guard-Health Affairs (MNGHA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 20, 2019
• Study Start: December 17, 2019
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)