ClinicalTrials.gov

History of Changes for Study: NCT04400838
Investigating a Vaccine Against COVID-19
Latest version (submitted June 18, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 22, 2020 None (earliest Version on record)
2 June 29, 2020 Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
3 July 9, 2020 Study Description and Study Status
4 August 11, 2020 Arms and Interventions, Outcome Measures, Eligibility, Study Design, Study Description and Study Status
5 August 21, 2020 Eligibility and Study Status
6 October 12, 2020 Outcome Measures, Arms and Interventions, Eligibility, Study Design, Study Description and Study Status
7 October 22, 2020 Eligibility and Study Status
8 November 12, 2020 Study Status
9 November 16, 2020 Outcome Measures, Eligibility and Study Status
10 December 8, 2020 Arms and Interventions, Eligibility, Outcome Measures, Study Description and Study Status
11 April 19, 2021 Eligibility, Outcome Measures and Study Status
12 June 18, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Description
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Changes (Merged) for Study: NCT04400838
August 21, 2020 (v5) -- October 12, 2020 (v6)

Changes in: Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures and Eligibility

Open or close this module Study Identification
Unique Protocol ID: COV002
Brief Title: Investigating a Vaccine Against COVID-19
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Recruiting
Study Start: May 28, 2020
Primary Completion: August 2021 [Anticipated]
Study Completion: August 2021 [Anticipated]
First Submitted: May 12, 2020
First Submitted that
Met QC Criteria:
May 22, 2020
First Posted: May 26, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 21, 2020 October 12, 2020
Last Update Posted: August 24 October 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oxford
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:

There will be 11 12 study groups and it is anticipated that a total of 12,330 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; group 3 is children aged 5-12 years inclusive; groups 4, 5 , 6 & 11 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

Open or close this module Conditions
Conditions: Coronavirus
Keywords: Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Sequential Assignment
Number of Arms: 24 28
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 12330 12390 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1 a1
Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) delivered intramuscularly
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 1 a3
Volunteers 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
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
Experimental: Group 1 b1
Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost (4-6 weeks apart) , delivered intramuscularly
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
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
Experimental: Group 2 a1
Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 2 a3
Volunteers 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
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
Experimental: Group 2 b1
.Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost ( 4-6 weeks apart ), delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
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
Experimental: Group 3 E
Volunteers will receive a single low dose of 2.5x10^10vp ChAdOx1 nCoV-19 (qPCR) delivered intramuscularly.
Biological: ChAdox1 n-CoV-19 (Abs 260) vaccine low dose
A single dose of 2.5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 4 a1
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp (Abs 260) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 4 b1
Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost ( 4-6 weeks apart ), delivered intramuscularly
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
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
Experimental: Group 4 c1
Volunteers will receive two doses of ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs260) prime and 2.2x10^10vp (qPCR) boost* ( , at least 4 6 weeks apart ), delivered intramuscularly
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
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
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
Experimental: Group 5 a1
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (Abs 260) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 5 a3
Volunteers 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
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
Experimental: Group 5 b1
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x1010vp, (qPCR) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 5 c1
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (qPCR) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 5 d1
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260 , corrected for PS80 )* , ( 4-6 weeks apart ) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 6 a1
Volunteers will receive a single dose ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 6 b1
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 5x1010vp (Abs260) prime and 0.5mL (3.5 - 6.5 × 1010 vp, Abs 260 , corrected for PS80 )* boost* ( at least 4 12 weeks apart , +2 weeks) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 7 a1
Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x 1010 10^10vp (qPCR) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 7 b1
Volunteers will receive two doses of ChAdOx1nCOV19 vaccine, 5x 1010 10^10vp (qPCR)* ( 4-6 weeks apart ) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 8 a1
Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x 1010 10^10vp (qPCR) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 8 b1
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260 , corrected for PS80 )* , ( 4-6 weeks apart ) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 9 a1
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260 , corrected for PS80 )* , ( 4-6 weeks apart ) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 10 a1
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260 , corrected for PS80 )* , ( 4-6 weeks apart ) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 11
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260 , corrected for PS80 )* , ( 4-6 weeks apart ) delivered intramuscularly.
Biological: ChAdOx1 nCoV-19 0.5mL prime plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260 , corrected for PS80 )
Experimental: Group 12
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
Active Comparator: Single dose MenACWY
Groups 1 a2, 2 a2, 3 a, 4 a2, 5 a2, 5 b2, 5 c2, 6 a2, 7 a2 & 8 a2 will receive a standard single dose of MenACWY vaccine delivered intramuscularly
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Active Comparator: Two dose MenACWY 4 - 6 weeks
Groups 1 b2, 2 b2, 4 b2, 4 c2, 5 d2, 7 b2, 8 b2, 9 a2 & 10 a2 will receive two doses of MenACWY 4-6 weeks apart delivered intramuscularly
Biological: Two dose MenACWY vaccine
Two standard doses of MenACWY vaccine 4-6 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Active Comparator: Two dose MenACWY minimum 4 12 weeks
Groups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will receive two doses of MenACWY ( at least 4 12 weeks apart , +2 weeks), delivered intramuscularly
Biological: Two dose MenACWY vaccine min. 4 12 weeks apart
Two standard doses of MenACWY vaccine minimum 4 12 weeks apart , + 2 weeks
Other Names:
  • Menveo
  • Nimenrix
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
[ Time Frame: 6 months Study duration (12 months from last vaccination) ]

Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children
[ Time Frame: 6 months Study duration (12 months from last vaccination) ]

Occurrence of serious adverse events (SAEs) throughout the study duration.
Secondary Outcome Measures:
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
[ Time Frame: 7 days post vaccination ]

Occurrence of solicited local reactogenicity signs and symptoms for 7 days following 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
[ Time Frame: 7 days post vaccination ]

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following 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
[ Time Frame: 28 days post vaccination ]

Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination (except groups 4 & 6)
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)
[ Time Frame: 6 months ]

Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4 and , 6, 9 & 10)
5. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
[ Time Frame: 6 months Study duration (12 months from last vaccination) ]

Occurrence of disease enhancement episodes
6. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions
[ Time Frame: 6 months Study duration (12 months from last vaccination) ]

Number of hospital admissions associated with COVID-19
7. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
[ Time Frame: 6 months ]

Number of intensive care unit (ICU) admissions associated with COVID-19
8. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths
[ Time Frame: 6 months ]

Number of deaths associated with COVID-19
9. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates
[ Time Frame: 6 months ]

Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
10. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19
[ Time Frame: Study duration (12 months from last vaccination) ]

Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)
10 11. Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification
[ Time Frame: 28 days post vaccination ]

Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
11 12. Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
[ Time Frame: 28 days post vaccination ]

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
12 13. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 3, 7 and 3 8 only)
[ Time Frame: 6 months ]

Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
13 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 2 8 only): local reactogenicity
[ Time Frame: 7 days post vaccination ]

Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
14 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
[ Time Frame: 7 days post vaccination ]

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
15 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)
[ Time Frame: 28 days post vaccination ]

Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
16 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)
[ Time Frame: 6 months ]

Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
17 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
[ Time Frame: 56 days post vaccination ]

Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
18 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)
[ Time Frame: 56 days post vaccination ]

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Other Outcome Measures:
1. Exploratory Immunology by virus neutralising antibody assays
[ Time Frame: 6 months ]

Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
2. Exploratory Immunology by flow cytometry
[ Time Frame: 6 months ]

Cell analysis by flow cytometry assays
3. Exploratory Immunology by functional antibody assays
[ Time Frame: 6 months ]

Functional antibody assays
4. Exploratory Immunology: anti-vector immunity
[ Time Frame: 6 months ]

Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19
5. Measure exposure to COVID-19
[ Time Frame: 6 months ]

Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures
6. Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection by PCR
[ Time Frame: 6 months ]

Number of PCR positive cases of COVID-19 infection
7. Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
[ Time Frame: 6 months ]

Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections
8. Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
[ Time Frame: 6 months ]

Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
9. Compare safety, reactogenicity and immunogenicity between different methods for measuring doses (Abs260, Abs260 corrected for PS80, and qPCR) of ChAdOx1 nCoV-19
[ Time Frame: 6 months ]

Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B / , C and D respectively (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
10. Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
[ Time Frame: 6 months ]

Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
11. Compare viral shedding on stool samples of SARS-CoV-2 PCR positive individuals
[ Time Frame: 6 months ]

Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 positivity
12. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: differences in antibody titres
[ Time Frame: 6 months ]

Differences in antibody titres (ELISA and Neutralising antibodies) in participants who received 1 or 2 doses of ChAdOx1 nCoV-19 (groups 1, 2, 7 and 8)
13. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: longevity of immune responses
[ Time Frame: 6 months ]

Longevity of immune responses in participants who received 1 or 2 doses of ChAdOx1 nCoV-19
14. Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines on safety and immune responses to ChAdOx1 nCoV-19
[ Time Frame: 6 months ]

Differences reactogenicity profile, antibody titres and T-cell responses between groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.
15. Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults
[ Time Frame: 6 months ]

Cell-mediated and humoral responses against SARS-Cov-2 These will be measured by the following:

  1. Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike protein measured by ELISA.
  2. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
  3. Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike protein responses
  4. Further exploratory immunology
16. Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: CD4 count-vaccine immune responses
[ Time Frame: 6 months ]

Relationship between nadir CD4 count vs vaccine immune responses
17. Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: age vs vaccine immune responses
[ Time Frame: 6 months ]

Relationship between age at enrolment and vaccine immune response
18. Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults
[ Time Frame: 6 months ]

Immune responses to ChAdOx1 nCoV-19 (assessed as described above)
19. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults
[ Time Frame: Study duration (12 months from last vaccination) ]

Measured by the following:

  1. Occurrence of serious adverse events (SAEs) throughout the study duration
  2. Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
  3. Occurrence of solicited systemic signs and symptoms for 7 days following each vaccination
  4. Occurrence of unsolicited AEs for 28 days following each vaccination
20. To assess Impact of vaccination on HIV reservoirs
[ Time Frame: Study duration (12 months from last vaccination) ]

Change in Total HIV DNA copies per million CD4 T cells
Open or close this module Eligibility
Minimum Age: 5 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • 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)
  • Children aged 5-12 years inclusive (group 3)
  • 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.
  • Parent/Guardian provides informed consent

Additional Inclusion criteria to Group 12 (HIV sub-study):

  • HIV positive
  • Receiving antiretroviral therapy
  • Undetectable HIV viral load
  • CD4>350 cells/mL

Exclusion Criteria:

• 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. Participants will be encouraged to receive this vaccination 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.
  • 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 o Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 9, 10 and 11).
    • Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 9, 10 and 11)
    • NB: volunteers with previous PCR 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

o Note: Caution should be taken when recommending paracetamol to adults who already take paracetamol chronically

Additional Exclusion Criteria to Group 3

  • Chronic medical conditions such as chronic lung disease, chronic liver disease, chronic renal failure, chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21)
  • Fulfil any of the contraindications to vaccination as specified in The Green Book

Re-vaccination exclusion criteria (two-dose groups only)

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy
  • Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results
Open or close this module Contacts/Locations
Central Contact Person: Volunteer Recruitment Coordinator
Telephone: 01865 611424
Email: vaccinetrials@ndm.ox.ac.uk
Study Officials: Andrew Pollard, Prof
Principal Investigator
University of Oxford
Locations: United Kingdom
University Hospitals Birmingham NHS Foundation Trust
[Recruiting]
Birmingham, United Kingdom
Contact:Principal Investigator: Christopher Green, PhD
University Hospitals Bristol and Weston NHS Foundation Trust
[Recruiting]
Bristol, United Kingdom, BS1 3NU
Contact:Contact: Adam Finn, Prof
North Bristol NHS Trust
[Recruiting]
Bristol, United Kingdom
Contact:Principal Investigator: Rajeka Lazarus, DPhil
NIHR Cambridge Clinical Research Facility
[Recruiting]
Cambridge, United Kingdom, CB2 0QQ
Contact:Principal Investigator: Mark Toshner, PhD
NHS Lothian, Western General Hospital
[Recruiting]
Edinburgh, United Kingdom, EH4 2XU
Contact:Principal Investigator: Rebecca Sutherland, MBChB
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
[Recruiting]
Glasgow, United Kingdom, G31 2ER
Contact:Principal Investigator: Emma Thompson, Prof
Contact:Principal Investigator: Andrew Smith, Prof
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
[Recruiting]
LIverpool, United Kingdom, L7 8XZ
Contact:Principal Investigator: Andrea Collins, PhD
London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
[Recruiting]
London, United Kingdom, HA1 3UJ
Contact:Principal Investigator: Alistair McGregor, DTM&H
University College London Hospitals NHS Foundation Trust
[Recruiting]
London, United Kingdom, NW1 2PG
Contact:Principal Investigator: Vincenzo Libri, FRCP
Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
[Recruiting]
London, United Kingdom, SE1 7EH
Contact:Principal Investigator: Anna Goodman, DPhil
Imperial College Healthcare NHS Trust
[Recruiting]
London, United Kingdom, W12 0HS
Contact:Principal Investigator: Katrina Pollock, DPhil
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
[Recruiting]
Newcastle upon Tyne, United Kingdom, NE1 4LP
Contact:Principal Investigator: Christopher Duncan, DPhil
Public Health Wales
[Recruiting]
Newport, United Kingdom, NP18 3XQ
Contact:Principal Investigator: Chris Williams, FFPH
University of Nottingham Health Service, Cripps Health Centre, University Park
[Recruiting]
Nottingham, United Kingdom, NG7 2QW
Contact:Principal Investigator: David Turner, PhD
CCVTM, University of Oxford, Churchill Hospital
[Recruiting]
Oxford, United Kingdom, OX3 7LE
Contact:Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk
Contact:Principal Investigator: Andrew Pollard, Prof
John Radcliffe Hospital
[Not yet recruiting]
Oxford, United Kingdom, OX3 9DU
Contact:Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
[Recruiting]
Sheffield, United Kingdom, S10 2RX
Contact:Principal Investigator: Thomas Darton, PhD
United Kingdom, Hampshire
University Hospital Southampton NHS Foundation Trust
[Recruiting]
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact:Contact: Study Coodinator UHS.RecruitmentCRF@nhs.net
Contact:Principal Investigator: Saul Faust, PhD
United Kingdom, Hull
Castle Hill Hospital
[Recruiting]
Cottingham, Hull, United Kingdom, HU16 5JQ
Contact:Principal Investigator: Patrick Lillie, PhD
United Kingdom, Tooting
St Georges University Hospital NHS Foundation Trust
[Recruiting]
London, Tooting, United Kingdom, SW17 0QT
Contact:Contact: Paul Heath, Prof
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