NCT04400838

Investigating a Vaccine Against COVID-19

A Phase 2/3 Study to Determine the Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10,811 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.

Detailed description

There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. Groups 1, 7 \& 9 are adults aged 56-69 years; groups 2, 8 \& 10 are adults 70 years and over; groups 4, 5 \& 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults aged 18-55 years. The vaccine will be administered intramuscularly into the deltoid of the non-dominant arm (preferably). 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 (Abs 260)	A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
BIOLOGICAL	MenACWY vaccine	Standard single dose of MenACWY vaccine
BIOLOGICAL	ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost	A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10\^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later
BIOLOGICAL	Two dose MenACWY vaccine	Two standard doses of MenACWY vaccine 4-6 weeks apart
BIOLOGICAL	ChAdOx1 nCoV-19 (qPCR)	A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by qPCR
BIOLOGICAL	ChAdOx1 nCoV-19 0.5mL prime plus boost	Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10\^10 vp Abs 260)
BIOLOGICAL	Two dose MenACWY vaccine min. 4 weeks apart	Two standard doses of MenACWY vaccine minimum 4 weeks apart
BIOLOGICAL	Two dose ChAdOx1 nCoV-19/Covishield 0.5mL	Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10\^11 vp/mL), 4-6 weeks apart
BIOLOGICAL	Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL	Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10\^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart

Timeline

• Start date: 2020-05-28
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2020-05-26
• Last updated: 2025-09-03

Locations

20 sites across 1 country: United Kingdom