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

NCT03399578 | Terminated Phase 1

• 1 other identifier: MERS001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 both as a single administration and with a homologous prime-booster.

Conditions

MERS (Middle East Respiratory Syndrome)

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

  up to 28 days following vaccination

Secondary Outcomes (1)

• Measures of immunogenicity to the ChAdOx1 MERS vaccine

  12 months

Study Arms (5)

Group 1

EXPERIMENTAL

Group 1 volunteers (n= 6) will be administered ChAdOx1 MERS, 5 x 10\^9 vp through intramuscular route.

Biological: ChAdOx1 MERS

Group 2

EXPERIMENTAL

Group 2 volunteers (n= 9) will be administered ChAdOx1 MERS, 2.5 x 10\^10 vp through intramuscular route.

Biological: ChAdOx1 MERS

Group 3

EXPERIMENTAL

Group 3 volunteers (n= 9) will be administered ChAdOx1 MERS, 5 x 10\^10 vp through intramuscular route.

Biological: ChAdOx1 MERS

Group 4

EXPERIMENTAL

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

Group 5

EXPERIMENTAL

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

Interventions

ChAdOx1 MERS BIOLOGICAL

The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen.

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

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

You may qualify if:

• The volunteer must satisfy all the following criteria to be eligible for the study:
• Healthy 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 discuss the volunteer's medical history with their General Practitioner or access this medical history electronically.
• 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
• Agreement to refrain from blood donation during the course of the study
• Provide written informed consent

You may not qualify if:

• The volunteer may not enter the study if any of the following apply:
• 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 (e.g. Adenovirus vectored vaccine).
• 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 abuse as defined by an alcohol intake of greater than 42 units every week
• Suspected or known injecting drug abuse in the 5 years preceding enrolment

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• Folegatti PM, Bittaye M, Flaxman A, Lopez FR, Bellamy D, Kupke A, Mair C, Makinson R, Sheridan J, Rohde C, Halwe S, Jeong Y, Park YS, Kim JO, Song M, Boyd A, Tran N, Silman D, Poulton I, Datoo M, Marshall J, Themistocleous Y, Lawrie A, Roberts R, Berrie E, Becker S, Lambe T, Hill A, Ewer K, Gilbert S. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial. Lancet Infect Dis. 2020 Jul;20(7):816-826. doi: 10.1016/S1473-3099(20)30160-2. Epub 2020 Apr 21.

  PMID: 32325038 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Middle East respiratory syndrome vaccine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Adrian V Hill, DPhil FRCP

  Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: March 14, 2018
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

GB (1)