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CoronavirusPhase 1/2NCT04324606

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

A Phase 1/2 study testing ChAdOx1 nCoV-19, MenACWY and ChAdOx1 nCoV-19 full boost in people with Coronavirus, run by University of Oxford at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Coronavirus
What is being tested?
ChAdOx1 nCoV-19, MenACWY and ChAdOx1 nCoV-19 full boost
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,077 participants
Where
6 sitesUnited Kingdom
Study dates
23 Apr 2020to 5 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The volunteer must satisfy all the following criteria to be eligible for the study:
  • Healthy adults aged 18-55 years.
  • Able and willing (in the Investigator's opinion) to comply with all study requirements (participants must not rely on public transport or taxis).
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
  • For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.
  • Agreement to refrain from blood donation during the course of the study.
  • Provide written informed consent.

Who cannot join

  • The volunteer may not enter the study if any of the following apply:
  • Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination .with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine.
  • Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days) .
  • Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
Show all 32Show fewer
  • History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 or MenACWY vaccines.
  • Any history of angioedema .
  • Any history of anaphylaxis .
  • Pregnancy, lactation or willingness/intention to become pregnant during the study.
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of serious psychiatric condition likely to affect participation in the study (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
  • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Any other serious chronic illness requiring hospital specialist supervision.
  • Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)
  • Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine)
  • Seriously overweight (BMI≥40 Kg/m2) or underweight (BMI≤18 Kg/m2)
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment.
  • Any clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
  • History of laboratory confirmed COVID-19.
  • New onset of fever or a cough or shortness of breath or anosmia/ageusia since February 2020. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment.
  • Those who have been at high risk of exposure before enrolment, including but not limited to: close contacts of confirmed COVID-19 cases, anyone who had to self-isolate as a result of a symptomatic household member, frontline healthcare professionals working in A\&E, ICU and other higher risk areas. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment.
  • Living in the same household as any vulnerable groups at risk of severe COVID-19 disease (as per Public Health England guidance)
  • Additional exclusion criteria (subset of participants receiving Paracetamol in group 4 only)
  • History of allergic disease or reactions likely to be exacerbated by Paracetamol
  • Re-vaccination exclusion criteria:
  • The following AEs associated with any vaccine, or identified on or before the day of vaccination constitute absolute contraindications to further administration of an IMP to the volunteer in question. If any of these events occur during the study, the subject will not be eligible to receive a booster dose and will be followed up by the clinical team or their GP until resolution or stabilisation of the event:
  • Anaphylactic reaction following administration of vaccine
  • Pregnancy. An exception to this will be prior to receipt of a booster dose at extra visit B. If a pregnant woman has discussed vaccination with their usual clinician (e.g. GP) and chooses to receive a COVID-19 vaccination, this may be administered by the trial team as part of extra visit B or as part of the provision of treatment to controls
  • Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS1 3NU

  • St Georges University Hospital NHS Foundation Trust

    London, SW17 0QT

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

  • CCVTM, University of Oxford, Churchill Hospital

    Oxford, OX3 7LE

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

Official title: 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

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

Read the 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
Coronavirus
Being tested
ChAdOx1 nCoV-19, MenACWY, ChAdOx1 nCoV-19 full boost, ChAdOx1 nCoV-19 half boost, MenACWY boost
Keywords
COVID-19, Vaccine
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAdOx1 nCoV-19Biological

    A single dose of 5x10^10vp of ChAdOx1 nCoV-19

  • MenACWYBiological

    Standard single dose of MenACWY vaccine delivered intramuscularly

  • ChAdOx1 nCoV-19 full boostBiological

    A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 5x10^10vp of ChAdOx1 nCoV-19

  • ChAdOx1 nCoV-19 half boostBiological

    A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10^10vp of ChAdOx1 nCoV-19

  • MenACWY boostBiological

    A standard dose of MenACWY followed by a boost dose of MenACWY

  • ParacetamolDrug

    1g every 6 hours for 24 hours

  • ChAdOx1 nCoV-19 0.5mL boostBiological

    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)

  • ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV)Biological

    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

  • ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT)Biological

    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

Study groups in NCT04324606
Study groupRoleWhat they receive
Group 1aExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
Receives: Biological: ChAdOx1 nCoV-19
Group 1bActive comparatorVolunteers will receive a standard single dose of MenACWY vaccine
Receives: Biological: MenACWY
Group 1cExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 5x10^10vp ChAdOx1 nCoV-19 9 months later
Receives: Biological: ChAdOx1 nCoV-19; Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV)
Group 1dExperimentalVolunteers will receive a standard single dose of MenACWY vaccine. 9 moths later they will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 4-12 weeks apart
Receives: Biological: MenACWY; Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT)
Group 2aExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
Receives: Biological: ChAdOx1 nCoV-19
Group 2bActive comparatorVolunteers will receive a standard single dose of MenACWY vaccine
Receives: Biological: MenACWY
Group 2cExperimentalVolunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and week 8
Receives: Biological: ChAdOx1 nCoV-19 full boost
Group 2dExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 2.5x10^10vp ChAdOx1 nCoV-19 at week 8
Receives: Biological: ChAdOx1 nCoV-19 half boost
Group 2eActive comparatorVolunteers will receive two standard single doses of MenACWY vaccine at week 0 and week 8
Receives: Biological: MenACWY boost
Group 2fExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later
Receives: Biological: ChAdOx1 nCoV-19 0.5mL boost
Group 2gActive comparatorVolunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart
Receives: Biological: MenACWY boost
Group 3aExperimentalVolunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 4
Receives: Biological: ChAdOx1 nCoV-19 full boost
Group 3bExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0, a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months
Receives: Biological: ChAdOx1 nCoV-19 full boost; Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV)
Group 4aExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
Receives: Biological: ChAdOx1 nCoV-19; Drug: Paracetamol
Group 4bActive comparatorVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly
Receives: Biological: MenACWY; Drug: Paracetamol
Group 4cExperimentalVolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later
Receives: Biological: ChAdOx1 nCoV-19; Biological: ChAdOx1 nCoV-19 0.5mL boost
Group 4dActive comparatorVolunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart
Receives: Biological: MenACWY boost
Group 5aExperimentalVolunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 ≤ 16 weeks apart, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months
Receives: Biological: ChAdOx1 nCoV-19 full boost; Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV)
Group 5bExperimentalVolunteers will receive two standard single doses of MenACWY vaccine ≤ 16 weeks apart, a dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months then a second dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) 4-12 weeks later
Receives: Biological: MenACWY boost; Biological: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases

    Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19

    Measured: 6 months

  2. Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)

    Occurrence of serious adverse events (SAEs) throughout the study until a cutoff date of 1st July 2021 or 6 months post late vaccination visit, whichever is latest

    Measured: Throughout the study, average of 18 months

Secondary outcomes (12)

  1. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms

    Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination

    Measured: 7 days following vaccination

  2. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms

    Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination

    Measured: 7 days following vaccination

  3. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)

    Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination (7 days following vaccination for groups 1c, 1d, 5a \& 5b)

    Measured: 7 or 28 days following vaccination

  4. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests

    Change from baseline for safety laboratory measures (haematology and biochemistry blood results)

    Measured: 6 months

  5. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes

    Occurrence of disease enhancement episodes

    Measured: 6 months

  6. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions

    Number of hospital admissions associated with COVID-19

    Measured: 6 months

  7. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions

    Number of intensive care unit admissions associated with COVID-19

    Measured: 6 months

  8. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related deaths

    Number of deaths associated with COVID-19

    Measured: 6 months

  9. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

    Occurrence of severe COVID-19 disease (defined according to clinical severity scales)

    Measured: 6 months

  10. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates

    Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study

    Measured: 6 months

  11. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays

    Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

    Measured: 6 months

  12. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19

    Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start23 Apr 2020
  3. Primary completion5 Feb 2025
  4. Study completion5 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
1,077 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04324606
Sponsor's protocol ID
COV001
Status last verified
Sep 2025
First submitted
20 Mar 2020
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thomas TM, Hodgson SH, Emary K, Patrick-Smith M, Te Water Naude R, Stuart ASV, Henry J, English M, Moore M, Douglas N, Pollard AJ, Vanderslott S. The collective voice of early phase COVID-19 vaccine trial participants: Insights for improving confidence in novel vaccines. Hum Vaccin Immunother. 2023 Dec 31;19(1):2203023. doi: 10.1080/21645515.2023.2203023.

    PubMed 37138460

  • Flaxman A, Marchevsky NG, Jenkin D, Aboagye J, Aley PK, Angus B, Belij-Rammerstorfer S, Bibi S, Bittaye M, Cappuccini F, Cicconi P, Clutterbuck EA, Davies S, Dejnirattisai W, Dold C, Ewer KJ, Folegatti PM, Fowler J, Hill AVS, Kerridge S, Minassian AM, Mongkolsapaya J, Mujadidi YF, Plested E, Ramasamy MN, Robinson H, Sanders H, Sheehan E, Smith H, Snape MD, Song R, Woods D, Screaton G, Gilbert SC, Voysey M, Pollard AJ, Lambe T; Oxford COVID Vaccine Trial group. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002). Lancet. 2021 Sep 11;398(10304):981-990. doi: 10.1016/S0140-6736(21)01699-8. Epub 2021 Sep 1.

    PubMed 34480858

  • Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Clutterbuck EA, Collins AM, Cutland CL, Darton TC, Dheda K, Dold C, Duncan CJA, Emary KRW, Ewer KJ, Flaxman A, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hill C, Hill HC, Hirsch I, Izu A, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Libri V, Lillie PJ, Marchevsky NG, Marshall RP, Mendes AVA, Milan EP, Minassian AM, McGregor A, Mujadidi YF, Nana A, Padayachee SD, Phillips DJ, Pittella A, Plested E, Pollock KM, Ramasamy MN, Ritchie AJ, Robinson H, Schwarzbold AV, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, White T, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials. Lancet. 2021 Mar 6;397(10277):881-891. doi: 10.1016/S0140-6736(21)00432-3. Epub 2021 Feb 19.

    PubMed 33617777

  • Barrett JR, Belij-Rammerstorfer S, Dold C, Ewer KJ, Folegatti PM, Gilbride C, Halkerston R, Hill J, Jenkin D, Stockdale L, Verheul MK, Aley PK, Angus B, Bellamy D, Berrie E, Bibi S, Bittaye M, Carroll MW, Cavell B, Clutterbuck EA, Edwards N, Flaxman A, Fuskova M, Gorringe A, Hallis B, Kerridge S, Lawrie AM, Linder A, Liu X, Madhavan M, Makinson R, Mellors J, Minassian A, Moore M, Mujadidi Y, Plested E, Poulton I, Ramasamy MN, Robinson H, Rollier CS, Song R, Snape MD, Tarrant R, Taylor S, Thomas KM, Voysey M, Watson MEE, Wright D, Douglas AD, Green CM, Hill AVS, Lambe T, Gilbert S, Pollard AJ; Oxford COVID Vaccine Trial Group. Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses. Nat Med. 2021 Feb;27(2):279-288. doi: 10.1038/s41591-020-01179-4. Epub 2020 Dec 17.

    PubMed 33335322

  • Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.

    PubMed 33306989

  • Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.

    PubMed 32702298

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ChAdOx1 nCoV-19, MenACWY and ChAdOx1 nCoV-19 full boost in people with Coronavirus, run by University of Oxford at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04324606, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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