Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
1077 participants
INTERVENTIONAL
2020-04-23
2025-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Group 1a
Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19
ChAdOx1 nCoV-19
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
Group 1b
Volunteers will receive a standard single dose of MenACWY vaccine
MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
Group 1c
Volunteers 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
ChAdOx1 nCoV-19
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
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
Group 1d
Volunteers 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
MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
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
Group 2a
Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19
ChAdOx1 nCoV-19
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
Group 2b
Volunteers will receive a standard single dose of MenACWY vaccine
MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
Group 2c
Volunteers will receive two doses of 5x10\^10vp ChAdOx1 nCoV-19 at week 0 and week 8
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
Group 2d
Volunteers 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
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
Group 2e
Volunteers will receive two standard single doses of MenACWY vaccine at week 0 and week 8
MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
Group 2f
Volunteers 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
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)
Group 2g
Volunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart
MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
Group 3a
Volunteers 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
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
Group 3b
Volunteers 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
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
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
Group 4a
Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19
ChAdOx1 nCoV-19
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
Paracetamol
1g every 6 hours for 24 hours
Group 4b
Volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 delivered intramuscularly
MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
Paracetamol
1g every 6 hours for 24 hours
Group 4c
Volunteers 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
ChAdOx1 nCoV-19
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
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)
Group 4d
Volunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart
MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
Group 5a
Volunteers 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
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
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
Group 5b
Volunteers 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
MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
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
Interventions
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ChAdOx1 nCoV-19
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19
MenACWY
Standard single dose of MenACWY vaccine delivered intramuscularly
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
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
MenACWY boost
A standard dose of MenACWY followed by a boost dose of MenACWY
Paracetamol
1g every 6 hours for 24 hours
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)
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
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
* Living in the same household as any vulnerable groups at risk of severe COVID-19 disease (as per Public Health England guidance)
• History of allergic disease or reactions likely to be exacerbated by Paracetamol
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
18 Years
55 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Andrew Pollard, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
St Georges University Hospital NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
CCVTM, University of Oxford, Churchill Hospital
Oxford, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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COV001
Identifier Type: -
Identifier Source: org_study_id
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