AzTrials
AzTrials

CoronavirusPhase 2/3NCT04400838

Investigating a Vaccine Against COVID-19

A Phase 2/3 study testing ChAdOx1 nCoV-19 (Abs 260), MenACWY vaccine and ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost in people with Coronavirus, run by University of Oxford at 20 sites in United Kingdom.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus
What is being tested?
ChAdOx1 nCoV-19 (Abs 260), MenACWY vaccine and ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,811 participants
Where
20 sitesUnited Kingdom
Study dates
28 May 2020to 5 Feb 2025
Phase
Phase 2/3
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Agreement to refrain from blood donation during the course of the study.
  • Provide written informed consent.
  • Additional Inclusion criteria to Group 12 (HIV sub-study):
  • HIV positive
  • Receiving antiretroviral therapy
  • Undetectable HIV viral load
  • CD4>350 cells/mL

Who cannot join

  • 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.
  • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine.
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  • 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)
  • Suspected or known current alcohol or drug dependency.
  • 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.
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
  • History of laboratory confirmed COVID-19 (except groups 5d, 5e, 5f, 9, 10 and 11).
  • Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 5f, 9, 10 and 11)
  • NB: volunteers with previous NAAT positive results are also allowed in groups 9, 10 and 11
  • Additional Exclusion criteria to Groups 4, 6, 9 and 10
  • History of allergic disease or reactions likely to be exacerbated by Paracetamol
  • Note: Caution should be taken when recommending paracetamol to adults who already take paracetamol chronically
  • Re-vaccination exclusion criteria (two-dose groups only)
  • 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. (Protocol 19.0) 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

20 sites in 1 country.

20 sites in 1 country

United Kingdom20 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS1 3NU

  • North Bristol NHS Trust

    Bristol

  • NIHR Cambridge Clinical Research Facility

    Cambridge, CB2 0QQ

  • Castle Hill Hospital

    Cottingham, Hull, HU16 5JQ

  • NHS Lothian, Western General Hospital

    Edinburgh, EH4 2XU

  • Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital

    Glasgow, G31 2ER

  • Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator

    Liverpool, L7 8XZ

  • St Georges University Hospital NHS Foundation Trust

    London, Tooting, SW17 0QT

  • London North West University Healthcare Trust (LNWUH), Northwick Park Hospital

    London, HA1 3UJ

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital

    London, SE1 7EH

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Public Health Wales

    Newport, NP18 3XQ

  • University of Nottingham Health Service, Cripps Health Centre, University Park

    Nottingham, NG7 2QW

  • CCVTM, University of Oxford, Churchill Hospital

    Oxford, OX3 7LE

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Sheffield Teaching Hospitals, Royal Hallamshire Hospital

    Sheffield, S10 2RX

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

Official title: A Phase 2/3 Study to Determine the Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19

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.

Read the detailed description

There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. Groups 1, 7 \& 9 are adults aged 56-69 years; groups 2, 8 \& 10 are adults 70 years and over; groups 4, 5 \& 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults aged 18-55 years.

The vaccine will be administered intramuscularly into the deltoid of the non-dominant arm (preferably).

All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant

Conditions
Coronavirus
Being tested
ChAdOx1 nCoV-19 (Abs 260), MenACWY vaccine, ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost, Two dose MenACWY vaccine, ChAdOx1 nCoV-19 (qPCR)
Keywords
Covid-19, ChAdOx1 nCov19, sars-cov-2, 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-19 (Abs 260)Biological

    A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260

  • MenACWY vaccineBiological

    Also called Menveo, Nimenrix

    Standard single dose of MenACWY vaccine

  • ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boostBiological

    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 dose MenACWY vaccineBiological

    Also called Menveo, Nimenrix

    Two standard doses of MenACWY vaccine 4-6 weeks apart

  • ChAdOx1 nCoV-19 (qPCR)Biological

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

  • ChAdOx1 nCoV-19 0.5mL prime plus boostBiological

    Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)

  • Two dose MenACWY vaccine min. 4 weeks apartBiological

    Also called Menveo, Nimenrix

    Two standard doses of MenACWY vaccine minimum 4 weeks apart

  • Two dose ChAdOx1 nCoV-19/Covishield 0.5mLBiological

    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 0.25mL & 0.5mLBiological

    Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart

Study groups in NCT04400838
Study groupRoleWhat they receive
Group 1 a1ExperimentalVolunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260)
Group 1 a3ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 1 b1ExperimentalVolunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost (4-6 weeks apart)
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
Group 2 a1ExperimentalVolunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260)
Group 2 a3ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 2 b1Experimental.Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
Group 4 a1ExperimentalVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp (Abs 260)
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260)
Group 4 b1ExperimentalVolunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
Group 4 c1ExperimentalVolunteers will receive two doses of ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs260) prime and 2.2x10^10vp (qPCR) boost*, at least 4 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 5 a1ExperimentalVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (Abs 260)
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260)
Group 5 a3ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 5 b1ExperimentalVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x1010vp, (qPCR)
Receives: Biological: ChAdOx1 nCoV-19 (qPCR)
Group 5 c1ExperimentalVolunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (qPCR)
Receives: Biological: ChAdOx1 nCoV-19 (Abs 260)
Group 5 d1ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 5 e1ExperimentalTwo dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart
Receives: Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.5mL
Group 5 f1ExperimentalTwo dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Receives: Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL
Group 6 a1ExperimentalVolunteers will receive a single dose ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR)
Receives: Biological: ChAdOx1 nCoV-19 (qPCR)
Group 6 b1ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 5x1010vp (Abs260) prime and 0.5mL (3.5 - 6.5 × 1010 vp, Abs 260)* boost* at least 4 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 7 a1ExperimentalVolunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)
Receives: Biological: ChAdOx1 nCoV-19 (qPCR)
Group 7 b1ExperimentalVolunteers will receive two doses of ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 8 a1ExperimentalVolunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)
Receives: Biological: ChAdOx1 nCoV-19 (qPCR)
Group 8 b1ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 9 a1ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 10 a1ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 11ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Group 12ExperimentalVolunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Receives: Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Single dose MenACWYActive 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
Receives: Biological: MenACWY vaccine
Two dose MenACWY 4 - 6 weeksActive 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
Receives: Biological: Two dose MenACWY vaccine
Two dose MenACWY minimum 4 weeksActive comparatorGroups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will receive two doses of MenACWY at least 4 weeks apart
Receives: Biological: Two dose MenACWY vaccine min. 4 weeks apart

What is being measured

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

  1. 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

    Measured: Study duration (12 months from last vaccination)

  2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults

    Occurrence of serious adverse events (SAEs) throughout the study duration.

    Measured: Study duration (12 months from last vaccination)

Secondary outcomes (19)

  1. 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

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

    Measured: 7 days post vaccination

  2. 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

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

    Measured: 7 days post vaccination

  3. 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

    Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

    Measured: 28 days post vaccination

  4. 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)

    Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 \& 10)

    Measured: 6 months

  5. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes

    Occurrence of disease enhancement episodes

    Measured: Study duration (12 months from last vaccination)

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

    Number of hospital admissions associated with COVID-19

    Measured: Study duration (12 months from last vaccination)

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

    Number of intensive care unit (ICU) admissions associated with COVID-19

    Measured: 6 months

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

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

    Measured: 6 months

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

    Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)

    Measured: Study duration (12 months from last vaccination)

  11. Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification

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

    Measured: 28 days post vaccination

  12. Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion

    Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination

    Measured: 28 days post vaccination

  13. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only)

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

    Measured: 6 months

  14. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity

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

    Measured: 7 days post vaccination

  15. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity

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

    Measured: 7 days post vaccination

  16. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)

    Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination

    Measured: 28 days post vaccination

  17. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests)

    Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)

    Measured: 6 months

  18. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion

    Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)

    Measured: 56 days post vaccination

  19. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)

    Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination

    Measured: 56 days post vaccination

Timeline

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

  1. First posted26 May 2020
  2. Study start28 May 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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
10,811 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400838
Sponsor's protocol ID
COV002
Status last verified
Sep 2025
First submitted
12 May 2020
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35192543

  • 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

  • Frater 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.

    PubMed 34153264

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Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ChAdOx1 nCoV-19 (Abs 260), MenACWY vaccine and ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost in people with Coronavirus, run by University of Oxford at 20 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 13 inclusion and 29 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 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older. (time frame: Study duration (12 months from last vaccination)). 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 NCT04400838, which also lists 8 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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