NCT03399578

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

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

All vaccinations will be administered intramuscularly. In Groups 1-3, each volunteer will receive one vaccination in total. In Groups 4 and 5, each volunteer will receive two vaccinations in total. There are five 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. Group 4 (n=6-12) will receive 2.5 x 10\^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10\^10 vp ChAdOx1 MERS at week 26. Group 5 (n=6-12) will receive 2.5 x 10\^10 vp ChAdOx1 MERS at week 0 followed by a boost of 2.5 x 10\^10 vp ChAdOx1 MERS at week 4. 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.

Conditions

• MERS (Middle East Respiratory Syndrome)

Interventions

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

Timeline

• Start date: 2018-03-14
• Primary completion: 2021-09-17
• Completion: 2021-09-17
• First posted: 2018-01-16
• Last updated: 2021-10-20

Locations

1 site across 1 country: United Kingdom