NCT04536051

A Study of a Candidate COVID-19 Vaccine (COV003)

A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,300 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.

Detailed description

There will be 2 study groups and an anticipated enrolment of 10,300 health professionals and adults with high potential for exposure to SARS-CoV-2, aged ≥18 years. All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 nCoV-19 single dose + paracetamol	Single dose of ChAdOx1nCOV19 vaccine, 5x10\^10 vp + paracetamol
BIOLOGICAL	MenACWY single dose + paracetamol	Single dose of MenACWY + paracetamol
BIOLOGICAL	ChAdOx1 nCoV-19 two dose + paracetamol	Two dose of ChAdOx1 nCoV-19 vaccine, 5x10\^10vp (prime) and 0.5mL boost (3.5 - 6.5 × 10\^10 vp), 4-12 weeks apart + paracetamol
BIOLOGICAL	MenACWY prime & saline placebo boost + paracetamol	MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol

Timeline

• Start date: 2020-06-02
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-09-02
• Last updated: 2020-11-27

Locations

6 sites across 1 country: Brazil