A Study of a Candidate COVID-19 Vaccine (COV001)

NCT04324606 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1077

Last updated 2025-09-03

No results posted yet for this study

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

Conditions

  • Coronavirus

Interventions

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

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew Pollard, Prof · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2025-02-05
Completion
2025-02-05

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04324606 on ClinicalTrials.gov