Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 23 Oct 2019

At a glance

  • Drugs Middle East respiratory syndrome coronavirus vaccine - Vaccitech (Primary)
  • Indications Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions
  • Most Recent Events

    • 18 Oct 2019 Planned number of patients changed from 24 to 48.
    • 18 Oct 2019 Planned End Date changed from 1 Dec 2019 to 1 Jul 2021.
    • 18 Oct 2019 Planned primary completion date changed from 1 Dec 2019 to 1 Jul 2021.

Trial Overview

Purpose

This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.

Primary Endpoints

Occurrence of solicited and unsolicited local and systemic adverse events

description: 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
time_frame: up to 28 days following vaccination

Other Endpoints

Measures of immunogenicity to the ChAdOx1 MERS vaccine

description: ELISA to quantify antibodies to MERS Spike protein antigen Ex vivo ELISpot responses to MERS Spike protein antigen
time_frame: 12 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
Middle East respiratory syndrome coronavirus prevention -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 48

  • Sex male & female
  • Age Group 18-50 years; adult

Patient 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 or access this medical history electronically. 4. For females only, willingness to practice continuous effective contraception 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT03399578 ClinicalTrials.gov: US National Institutes of Health
MERS001 -

Organisations

  • Affiliations Vaccitech

Trial Dates

  • Initiation Dates

    Planned : 01 Jan 2018

    Actual : 14 Mar 2018

  • Primary Completion Dates

    Planned : 01 Jul 2021

  • End Dates

    Planned : 01 Jul 2021

Other Details

  • Design open; parallel; prospective
  • Phase of Trial Phase I
  • Location England
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
Middle East respiratory syndrome coronavirus vaccine - VaccitechPrimary Drug Intramuscular
-

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.)

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.)

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.)

Group 4

Group 4 volunteers (n=6-12) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp at week 0, followed by ChAdOx1 MERS, 2.5 x 10^10 vp at week 26. Both administrations will be given 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.)

Group 5

Group 5 volunteers (n=6-12) will be administered ChAdOx1 MERS, 2.5 x 10^10 vp at week 0, followed by ChAdOx1 MERS, 2.5 x 10^10 vp at week 4. Both administrations will be given 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.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Adrian Hill, DPhil FRCP
vaccinetrials@ndm.ox.ac.uk
show details
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital United-Kingdom
Adrian V Hill, DPhil FRCP
vaccinetrials@ndm.ox.ac.uk
show details
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom United-Kingdom
Volunteer Coordinator
01865 611424 vaccinetrials@ndm.ox.ac.uk
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital Oxford United-Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital Oxford United-Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
-
-
University of Oxford
Volunteer Coordinator
01865 611424
vaccinetrials@ndm.ox.ac.uk
show details
-
-

Trial History

Event Date Event Type Comment
23 Oct 2019 Other trial event Last checked against ClinicalTrials.gov record. Updated 23 Oct 2019
18 Oct 2019 Other trial event Planned number of patients changed from 24 to 48. Updated 23 Oct 2019
18 Oct 2019 Completion date Planned End Date changed from 1 Dec 2019 to 1 Jul 2021. Updated 23 Oct 2019
18 Oct 2019 Other trial event Planned primary completion date changed from 1 Dec 2019 to 1 Jul 2021. Updated 23 Oct 2019
09 May 2019 Completion date Planned End Date changed from 1 Mar 2019 to 1 Dec 2019. Updated 14 May 2019
09 May 2019 Other trial event Planned primary completion date changed from 1 Mar 2019 to 1 Dec 2019. Updated 14 May 2019
10 Apr 2018 Completion date Planned End Date changed from 1 Jan 2019 to 1 Mar 2019. Updated 13 Apr 2018
10 Apr 2018 Other trial event Planned primary completion date changed from 1 Jan 2019 to 1 Mar 2019. Updated 13 Apr 2018
10 Apr 2018 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 13 Apr 2018
22 Jan 2018 New trial record New trial record Updated 22 Jan 2018

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. ProBioGen. ProBioGen and Vaccitech Sign License Agreement for ProBioGens Technology Platform. Media-Rel 2019;.

    Media Release
Back to top