Trials / Completed
CompletedNCT04324606
A Study of a Candidate COVID-19 Vaccine (COV001)
A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1,077 (actual)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm
Detailed description
There will be 4 study groups and it is anticipated that a total of 1090 volunteers will be enrolled. Volunteers will participate in the study for approximately 12 months from last vaccination visit (approximately 15 months from enrolment for participants receiving 2 doses)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ChAdOx1 nCoV-19 | A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 |
| BIOLOGICAL | MenACWY | Standard single dose of MenACWY vaccine delivered intramuscularly |
| BIOLOGICAL | ChAdOx1 nCoV-19 full boost | A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 5x10\^10vp of ChAdOx1 nCoV-19 |
| BIOLOGICAL | ChAdOx1 nCoV-19 half boost | A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10\^10vp of ChAdOx1 nCoV-19 |
| BIOLOGICAL | MenACWY boost | A standard dose of MenACWY followed by a boost dose of MenACWY |
| DRUG | Paracetamol | 1g every 6 hours for 24 hours |
| BIOLOGICAL | ChAdOx1 nCoV-19 0.5mL boost | A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 followed by a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10\^10vp) |
| BIOLOGICAL | ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) | A dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10\^10vp) 9 months after receiving a single or double dose of 5x10\^10vp of ChAdOx1 nCoV-19 |
| BIOLOGICAL | ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT) | A dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10\^10vp) 9 months after receiving a single or double dose of MenACWY, then a boost 4-12 weeks later |
Timeline
- Start date
- 2020-04-23
- Primary completion
- 2025-02-05
- Completion
- 2025-02-05
- First posted
- 2020-03-27
- Last updated
- 2025-09-03
Locations
6 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04324606. Inclusion in this directory is not an endorsement.