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
1 other identifier
interventional
10,811
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2020
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedStudy Start
First participant enrolled
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2025
CompletedSeptember 3, 2025
September 1, 2025
4.7 years
May 12, 2020
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Study duration (12 months from last vaccination)
Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults
Occurrence of serious adverse events (SAEs) throughout the study duration.
Study duration (12 months from last vaccination)
Secondary Outcomes (19)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following
7 days post vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following
7 days post vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
28 days post vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests)
6 months
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
Study duration (12 months from last vaccination)
- +14 more secondary outcomes
Other Outcomes (21)
Exploratory Immunology by virus neutralising antibody assays
6 months
Exploratory Immunology by flow cytometry
6 months
Exploratory Immunology by functional antibody assays
6 months
- +18 more other outcomes
Study Arms (29)
Group 1 a1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10\^10vp (Abs 260)
Group 1 a3
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10\^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260) boost, minimum 4 weeks from prime
Group 1 b1
EXPERIMENTALVolunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10\^10vp (Abs 260) prime and 2.2x10\^10vp (qPCR) boost (4-6 weeks apart)
Group 2 a1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10\^10vp (Abs 260)
Group 2 a3
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10\^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260) boost, minimum 4 weeks apart
Group 2 b1
EXPERIMENTAL.Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10\^10vp (Abs 260) prime and 2.2x10\^10vp (qPCR) boost 4-6 weeks apart
Group 4 a1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10\^10vp (Abs 260)
Group 4 b1
EXPERIMENTALVolunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10\^10vp (Abs 260) prime and 2.2x10\^10vp (qPCR) boost 4-6 weeks apart
Group 4 c1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCOV19 vaccine, 5x10\^10vp (Abs260) prime and 2.2x10\^10vp (qPCR) boost\*, at least 4 weeks apart
Group 5 a1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10\^10vp, (Abs 260)
Group 5 a3
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10\^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260) boost, minimum 4 weeks from prime
Group 5 b1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x1010vp, (qPCR)
Group 5 c1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10\^10vp, (qPCR)
Group 5 d1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260)\* 4-6 weeks apart
Group 5 e1
EXPERIMENTALTwo dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10\^11 vp/mL), 4-6 weeks apart
Group 5 f1
EXPERIMENTALTwo dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10\^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Group 6 a1
EXPERIMENTALVolunteers will receive a single dose ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR)
Group 6 b1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 5x1010vp (Abs260) prime and 0.5mL (3.5 - 6.5 Ă— 1010 vp, Abs 260)\* boost\* at least 4 weeks apart
Group 7 a1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10\^10vp (qPCR)
Group 7 b1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1nCOV19 vaccine, 5x10\^10vp (qPCR)\* 4-6 weeks apart
Group 8 a1
EXPERIMENTALVolunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10\^10vp (qPCR)
Group 8 b1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260)\* 4-6 weeks apart
Group 9 a1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260)\* 4-6 weeks apart
Group 10 a1
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260)\* 4-6 weeks apart
Group 11
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260)\* 4-6 weeks apart
Group 12
EXPERIMENTALVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 Ă— 10\^10 vp, Abs 260)\* 4-6 weeks apart
Single dose MenACWY
ACTIVE COMPARATORGroups 1 a2, 2 a2, 4 a2, 5 a2, 5 b2, 5 c2, 6 a2, 7 a2 \& 8 a2 will receive a standard single dose of MenACWY vaccine
Two dose MenACWY 4 - 6 weeks
ACTIVE COMPARATORGroups 1 b2, 2 b2, 4 b2, 5 d2, 7 b2, 8 b2, 9 a2 \& 10 a2 will receive two doses of MenACWY 4-6 weeks apart
Two dose MenACWY minimum 4 weeks
ACTIVE COMPARATORGroups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will receive two doses of MenACWY at least 4 weeks apart
Interventions
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Standard single dose of MenACWY vaccine
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
Two standard doses of MenACWY vaccine 4-6 weeks apart
A single dose of 5x10\^10vp of ChAdOx1 nCoV-19 measured by qPCR
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 Ă— 10\^10 vp Abs 260)
Two standard doses of MenACWY vaccine minimum 4 weeks apart
Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10\^11 vp/mL), 4-6 weeks apart
Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10\^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Eligibility Criteria
You may qualify if:
- Adults aged 18 - 55 years (groups 4, 5, 6 and 11)
- Adults aged 56-69 years (groups 1, 7, and 9)
- Adults aged 70 years and older (groups 2, 8, and 10)
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- 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 of childbearing potential 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.
- HIV positive
- Receiving antiretroviral therapy
- Undetectable HIV viral load
- CD4\>350 cells/mL
You may not qualify if:
- Participation in COVID-19 prophylactic drug trials for the duration of the study.
- Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible.
- Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
- Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
- Receipt of any vaccine (licensed or investigational) 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 vaccination. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine.
- 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 (except group 12, where HIV infected participants are allowed); 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)
- History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
- Any history of angioedema.
- Any history of anaphylaxis.
- Pregnancy, lactation or willingness/intention to become pregnant during the study.
- Current diagnosis of or treatment for 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.
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Castle Hill Hospital
Cottingham, Hull, HU16 5JQ, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, Tooting, SW17 0QT, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS1 3NU, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
NIHR Cambridge Clinical Research Facility
Cambridge, CB2 0QQ, United Kingdom
NHS Lothian, Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
Glasgow, G31 2ER, United Kingdom
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
Liverpool, L7 8XZ, United Kingdom
London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
London, HA1 3UJ, United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
London, SE1 7EH, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Public Health Wales
Newport, NP18 3XQ, United Kingdom
University of Nottingham Health Service, Cripps Health Centre, University Park
Nottingham, NG7 2QW, United Kingdom
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
Sheffield, S10 2RX, United Kingdom
Related Publications (8)
Ogbe A, Pace M, Bittaye M, Tipoe T, Adele S, Alagaratnam J, Aley PK, Ansari MA, Bara A, Broadhead S, Brown A, Brown H, Cappuccini F, Cinardo P, Dejnirattisai W, Ewer KJ, Fok H, Folegatti PM, Fowler J, Godfrey L, Goodman AL, Jackson B, Jenkin D, Jones M, Longet S, Makinson RA, Marchevsky NG, Mathew M, Mazzella A, Mujadidi YF, Parolini L, Petersen C, Plested E, Pollock KM, Rajeswaran T, Ramasamy MN, Rhead S, Robinson H, Robinson N, Sanders H, Serrano S, Tipton T, Waters A, Zacharopoulou P, Barnes E, Dunachie S, Goulder P, Klenerman P, Screaton GR, Winston A, Hill AV, Gilbert SC, Carroll M, Pollard AJ, Fidler S, Fox J, Lambe T, Frater J. Durability of ChAdOx1 nCoV-19 vaccination in people living with HIV. JCI Insight. 2022 Apr 8;7(7):e157031. doi: 10.1172/jci.insight.157031.
PMID: 35192543DERIVEDFlaxman 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.
PMID: 34480858DERIVEDFrater J, Ewer KJ, Ogbe A, Pace M, Adele S, Adland E, Alagaratnam J, Aley PK, Ali M, Ansari MA, Bara A, Bittaye M, Broadhead S, Brown A, Brown H, Cappuccini F, Cooney E, Dejnirattisai W, Dold C, Fairhead C, Fok H, Folegatti PM, Fowler J, Gibbs C, Goodman AL, Jenkin D, Jones M, Makinson R, Marchevsky NG, Mujadidi YF, Nguyen H, Parolini L, Petersen C, Plested E, Pollock KM, Ramasamy MN, Rhead S, Robinson H, Robinson N, Rongkard P, Ryan F, Serrano S, Tipoe T, Voysey M, Waters A, Zacharopoulou P, Barnes E, Dunachie S, Goulder P, Klenerman P, Screaton GR, Winston A, Hill AVS, Gilbert SC, Pollard AJ, Fidler S, Fox J, Lambe T; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial. Lancet HIV. 2021 Aug;8(8):e474-e485. doi: 10.1016/S2352-3018(21)00103-X. Epub 2021 Jun 18.
PMID: 34153264DERIVEDEmary KRW, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, Blane B, Bonsall D, Cicconi P, Charlton S, Clutterbuck EA, Collins AM, Cox T, Darton TC, Dold C, Douglas AD, Duncan CJA, Ewer KJ, Flaxman AL, Faust SN, Ferreira DM, Feng S, Finn A, Folegatti PM, Fuskova M, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hallis B, Heath PT, Hay J, Hill HC, Jenkin D, Kerridge S, Lazarus R, Libri V, Lillie PJ, Ludden C, Marchevsky NG, Minassian AM, McGregor AC, Mujadidi YF, Phillips DJ, Plested E, Pollock KM, Robinson H, Smith A, Song R, Snape MD, Sutherland RK, Thomson EC, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Williams CJ, Hill AVS, Lambe T, Gilbert SC, Voysey M, Ramasamy MN, Pollard AJ; COVID-19 Genomics UK consortium; AMPHEUS Project; Oxford COVID-19 Vaccine Trial Group. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. Lancet. 2021 Apr 10;397(10282):1351-1362. doi: 10.1016/S0140-6736(21)00628-0. Epub 2021 Mar 30.
PMID: 33798499DERIVEDVoysey 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.
PMID: 33617777DERIVEDEwer KJ, Barrett JR, Belij-Rammerstorfer S, Sharpe H, Makinson R, Morter R, Flaxman A, Wright D, Bellamy D, Bittaye M, Dold C, Provine NM, Aboagye J, Fowler J, Silk SE, Alderson J, Aley PK, Angus B, Berrie E, Bibi S, Cicconi P, Clutterbuck EA, Chelysheva I, Folegatti PM, Fuskova M, Green CM, Jenkin D, Kerridge S, Lawrie A, Minassian AM, Moore M, Mujadidi Y, Plested E, Poulton I, Ramasamy MN, Robinson H, Song R, Snape MD, Tarrant R, Voysey M, Watson MEE, Douglas AD, Hill AVS, Gilbert SC, Pollard AJ, Lambe T; Oxford COVID Vaccine Trial Group. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nat Med. 2021 Feb;27(2):270-278. doi: 10.1038/s41591-020-01194-5. Epub 2020 Dec 17.
PMID: 33335323DERIVEDVoysey 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.
PMID: 33306989DERIVEDRamasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, Voysey M, Aley PK, Angus B, Babbage G, Belij-Rammerstorfer S, Berry L, Bibi S, Bittaye M, Cathie K, Chappell H, Charlton S, Cicconi P, Clutterbuck EA, Colin-Jones R, Dold C, Emary KRW, Fedosyuk S, Fuskova M, Gbesemete D, Green C, Hallis B, Hou MM, Jenkin D, Joe CCD, Kelly EJ, Kerridge S, Lawrie AM, Lelliott A, Lwin MN, Makinson R, Marchevsky NG, Mujadidi Y, Munro APS, Pacurar M, Plested E, Rand J, Rawlinson T, Rhead S, Robinson H, Ritchie AJ, Ross-Russell AL, Saich S, Singh N, Smith CC, Snape MD, Song R, Tarrant R, Themistocleous Y, Thomas KM, Villafana TL, Warren SC, Watson MEE, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Faust SN, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2021 Dec 19;396(10267):1979-1993. doi: 10.1016/S0140-6736(20)32466-1. Epub 2020 Nov 19.
PMID: 33220855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Pollard, Prof
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 26, 2020
Study Start
May 28, 2020
Primary Completion
February 5, 2025
Study Completion
February 5, 2025
Last Updated
September 3, 2025
Record last verified: 2025-09