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Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001)

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ClinicalTrials.gov Identifier: NCT03399578
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone as a single administration.

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

Detailed Description:

All vaccinations will be administered intramuscularly. Each volunteer will receive one vaccination in total.

There are three different vaccine schedules:

Group 1 (n=6) will receive 5 x 10^9 vp ChAdOx1 MERS .

Group 2 (n=9) will receive 2.5 x 10^10 vp ChAdOx1 MERS.

Group 3 (n=9) will receive 5 x 10^10 vp ChAdOx1 MERS.

The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.

Healthy adult volunteers will be recruited in Oxford, England.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Group 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10^9 vp through intramuscular route.
Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.

Experimental: Group 2
Group 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp through intramuscular route.
Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.

Experimental: Group 3
Group 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10^10 vp through intramuscular route.
Biological: ChAdOx1 MERS
The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.




Primary Outcome Measures :
  1. Occurrence of solicited and unsolicited local and systemic adverse events [ Time Frame: up to 28 days following 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 months ]
    ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen



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

Inclusion Criteria:

The volunteer must satisfy all the following criteria to be eligible for the study:

  1. Healthy 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 discuss the volunteer's medical history with their General Practitioner
  4. For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
  5. Agreement to refrain from blood donation during the course of the study
  6. Provide written informed consent

Exclusion Criteria:

The volunteer may not enter the study if any of the following apply:

  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 (e.g. Adenovirus vectored vaccine).
  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 abuse as defined by an alcohol intake of greater than 42 units every week
  14. Suspected or known injecting 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. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
  20. Prior exposure to MERS-CoV (serology will be requested at the discretion of the investigator)
  21. History of allergic reaction to Aminoglycoside antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399578


Contacts
Contact: Volunteer Coordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital Recruiting
Oxford, United Kingdom
Contact: Adrian Hill, DPhil FRCP       vaccinetrials@ndm.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Adrian V Hill, DPhil FRCP Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03399578     History of Changes
Other Study ID Numbers: MERS001
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Coronavirus Infections
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs