ClinicalTrials.gov

History of Changes for Study: NCT04400838
Investigating a Vaccine Against COVID-19
Latest version (submitted December 8, 2020) 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
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04400838
July 9, 2020 (v3) -- August 11, 2020 (v4)

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

Study Identification
Unique Protocol ID: COV002 COV002
Brief Title: Investigating a Vaccine Against COVID-19 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 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:
Study Status
Record Verification: May 2020 May 2020
Overall Status: Recruiting Recruiting
Study Start: May 28, 2020 May 28, 2020
Primary Completion: August 2021 [Anticipated ] August 2021 [Anticipated ]
Study Completion: August 2021 [Anticipated ] August 2021 [Anticipated ]
First Submitted: May 12, 2020 May 12, 2020
First Submitted that
Met QC Criteria:
May 22, 2020 May 22, 2020
First Posted: May 26, 2020 [Actual ] May 26, 2020 [Actual ]
Last Update Submitted that
Met QC Criteria:
July 9, 2020 August 11, 2020
Last Update Posted: July 13, 2020 [Actual ] August 14, 2020 [Actual ]
Sponsor/Collaborators
Sponsor: University of Oxford University of Oxford
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: No No
U.S. FDA-regulated Device: No No
Data Monitoring: Yes Yes
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. 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 8 study groups and it is anticipated that a total of 10,560 volunteers will be enrolled. Groups 1 & 7 are adults aged 56-69 years; groups 2 & 8 are adults 70 years and over; group 3 is children aged 5-12 years; groups 4 and 6 are adults over the age of 18; group 5 is adults aged 18-55 years.

All subjects will undergo follow-up for a total of 1 year post enrolment. 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

There will be 11 study groups and it is anticipated that a total of 12,330 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 are adults aged 18-55 years.

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
Conditions: Coronavirus Coronavirus
Keywords: Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Study Design
Study Type: InterventionalInterventional
Primary Purpose: PreventionPrevention
Study Phase: Phase 2/Phase 3Phase 2/Phase 3
Interventional Study Model: Sequential Assignment Sequential Assignment
Number of Arms: 3024
Masking: Single (Participant)Single (Participant)
Allocation: RandomizedRandomized
Enrollment: 10260 [Anticipated ] 12330 [Anticipated ]
Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1 aE a1
Volunteers will receive a single dose of ChAdOx1 nCOV19 vaccine, 5x10^10vp ChAdOx1 nCoV-19 (Abs 260) delivered intramuscularly . Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Active Comparator: Group 1aA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Active Comparator: Group 1bA Experimental: Group 1 b1
Volunteers will receive two doses of MenACWY 4-6 weeks apart delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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
Biological: Two dose MenACWY vaccine
Two standard doses of MenACWY vaccine 4-6 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 2 aE a1
Volunteers will receive a single dose of ChAdOx1 nCOV19 vaccine, 5x10^10vp ChAdOx1 nCoV-19 (Abs 260) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 2 b1 bE
Volunteers will receive one two dose of ChAdOx1 nCOV19 vaccine, 5x10^10vp ChAdOx1 nCoV-19 (Abs 260) at week 0 prime and one dose of 2.2x10^10vp ChAdOx1 nCoV-19 (qPCR) at week boost (4-6 weeks apart), delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
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
Active Comparator: Group 2aA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 3E
Volunteers will receive a single low dose of 2.5x10^10vp ChAdOx1 nCoV-19 (qPCR) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdox1 n-CoV-19 (Abs 260) vaccine low dose
A single dose of 2.5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Active Comparator: Group 3A
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Active Comparator: Group 4bA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: Two dose MenACWY vaccine
Two standard doses of MenACWY vaccine 4-6 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 5aE 4 a1
Volunteers will receive a single dose of ChAdOx1 nCoV19 vaccine, 5x10^10vp ChAdOx1 nCoV-19 (Abs 260) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 2bE 4 b1
Volunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 (Abs260) at week 0 and one dose of 2.2x10^10vp ChAdOx1 nCoV-19 (qPCR) at week 4-6 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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 bE c1
Volunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 (Abs260) at week 0 and one dose of 2.2x10^10vp ChAdOx1 nCoV-19 (qPCR) at week 4-6 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs260) 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 4aE 5 a1
Volunteers will receive a single dose of ChAdOx1 nCoV19 vaccine, 5x10^10vp ChAdOx1 nCoV-19 , (Abs 260) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Experimental: Group 7aE 5 b1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV19 vaccine, 5x1010vp, (qPCR) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Active Comparator: Group 7aA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 8aE 5 c1
Volunteers will receive a single dose of ChAdOx1 nCoV19 vaccine, 5x10^10vp ChAdOx1 nCoV-19 , (qPCR) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
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
Active Comparator: Group 2bA Experimental: Group 5 d1
Volunteers will receive two doses of MenACWY 4-6 weeks apart delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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: Two dose MenACWY vaccine
Two standard doses of MenACWY vaccine 4-6 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Biological: ChAdOx1 nCoV-19 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 E a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Active Comparator: Group 4aA Experimental: Group 6 b1
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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* (4-12 weeks apart, +2 weeks) delivered intramuscularly.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Biological: ChAdOx1 nCoV-19 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 5cE 7 a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1nCOV19 vaccine, 5x1010vp (qPCR) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Experimental: Group 7 bE b1
Volunteers will receive two doses of 5x10^10vp ChAdOx1nCOV19 vaccine, 5x1010vp (qPCR)* (4-6 weeks apart) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR)
Two doses of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR 4-6 weeks apart Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260, corrected for PS80)
Experimental: Group 5bE 8 a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1nCOV19 vaccine, 5x1010vp (qPCR) delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Active Comparator: Group 5bA Experimental: Group 8 b1
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Biological: ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260, corrected for PS80)
Active Comparator: Group 5aA Experimental: Group 9 a1
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Biological: ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260, corrected for PS80)
Active Comparator: Group 5cA Experimental: Group 10 a1
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Biological: ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR)
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260, corrected for PS80)
Active Comparator: Group 8aA
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator.
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 8bE 11
Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 (qPCR) 4-6 weeks delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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 plus 5x10^10vp boost (qPCR)
Two doses of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR 4-6 weeks apart Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260, corrected for PS80)
Active Comparator: Group 6A Single dose MenACWY
Volunteers will receive a standard single dose of MenACWY vaccine delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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: Group 8bA Two dose MenACWY
Volunteers will receive two doses of MenACWY 4-6 weeks apart delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. 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: Group 7bA Active Comparator: Two dose MenACWY 4-12 weeks
Volunteers will receive two doses of MenACWY 4-6 weeks apart delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Group 6b2 will receive two doses of MenACWY (4-12 weeks apart, +2 weeks), delivered intramuscularly
Biological: Two dose MenACWY vaccine
Two standard doses of MenACWY vaccine 4-6 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Biological: Two dose MenACWY vaccine 4-12 weeks
Two standard doses of MenACWY vaccine 4-12 weeks apart, + 2 weeks
Other Names:
  • Menveo
  • Nimenrix
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.
Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19

[Time Frame: 6 months ]
Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19

[Time Frame: 6 months ]
2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children
Occurrence of serious adverse events (SAEs) throughout the study duration.

[Time Frame: 6 months ]
Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children
Occurrence of serious adverse events (SAEs) throughout the study duration.

[Time Frame: 6 months ]
Secondary Outcome Measures:
3. 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

[Time Frame: 7 days post vaccination ]
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

[Time Frame: 7 days post vaccination ]
4. 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

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

[Time Frame: 7 days post vaccination ]
5. 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 (except groups 4 & 6)

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

[Time Frame: 28 days post vaccination ]
6. 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 and 6)

[Time Frame: 6 months ]
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 and 6)

[Time Frame: 6 months ]
7. 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

[Time Frame: 6 months ]
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

[Time Frame: 6 months ]
8. 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

[Time Frame: 6 months ]
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

[Time Frame: 6 months ]
9. 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

[Time Frame: 6 months ]
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

[Time Frame: 6 months ]
10. 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

[Time Frame: 6 months ]
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

[Time Frame: 6 months ]
11. 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

[Time Frame: 6 months ]
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

[Time Frame: 6 months ]
12. Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

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

[Time Frame: 28 days post vaccination ]
13. Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination

[Time Frame: 28 days post vaccination ]
Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination

[Time Frame: 28 days post vaccination ]
14. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2 and 3 only)
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

[Time Frame: 6 months ]
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2 and 3 only)
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

[Time Frame: 6 months ]
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): local reactogenicity
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination

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

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

[Time Frame: 7 days post vaccination ]
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

[Time Frame: 7 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)
Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination

[Time Frame: 28 days post vaccination ]
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

[Time Frame: 28 days post vaccination ]
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) 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)

[Time Frame: 6 months ]
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)

[Time Frame: 6 months ]
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) via seroconversion
Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)

[Time Frame: 56 days post vaccination ]
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)

[Time Frame: 56 days post vaccination ]
20. 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

[Time Frame: 56 days post vaccination ]
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

[Time Frame: 56 days post vaccination ]
Other Pre-specified Outcome Measures:
21. Exploratory Immunology by virus neutralising antibody assays
Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus

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

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

[Time Frame: 6 months ]
Exploratory Immunology by flow cytometry
Cell analysis by flow cytometry assays

[Time Frame: 6 months ]
23. Exploratory Immunology by functional antibody assays
Functional antibody assays

[Time Frame: 6 months ]
Exploratory Immunology by functional antibody assays
Functional antibody assays

[Time Frame: 6 months ]
24. Exploratory Immunology: anti-vector immunity
Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19

[Time Frame: 6 months ]
25. Measure exposure to COVID-19
Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures

[Time Frame: 6 months ]
Measure exposure to COVID-19
Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures

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

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

[Time Frame: 6 months ]
27. Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections

[Time Frame: 6 months ]
Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections

[Time Frame: 6 months ]
28. Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
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).

[Time Frame: 6 months ]
Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
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).

[Time Frame: 6 months ]
29. Compare safety, reactogenicity and immunogenicity between different methods for measuring doses (Abs260 and qPCR) of ChAdOx1 nCoV-19
Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B/C (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).

[Time Frame: 6 months ]
Compare safety, reactogenicity and immunogenicity between different methods for measuring doses (Abs260, Abs260 corrected for PS80, and qPCR) of ChAdOx1 nCoV-19
Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B/C (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).

[Time Frame: 6 months ]
30. Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
Nasal mucosa IgA levels at D0 and D28 in a subset of individuals

[Time Frame: 6 months ]
Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
Nasal mucosa IgA levels at D0 and D28 in a subset of individuals

[Time Frame: 6 months ]
31. Compare viral shedding on stool samples of SARS-CoV-2 PCR positive individuals
Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 positivity

[Time Frame: 6 months ]
Compare viral shedding on stool samples of SARS-CoV-2 PCR positive individuals
Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 positivity

[Time Frame: 6 months ]
32. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: differences in antibody titres
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)

[Time Frame: 6 months ]
33. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: longevity of immune responses
Longevity of immune responses in participants who received 1 or 2 doses of ChAdOx1 nCoV-19

[Time Frame: 6 months ]
34. Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines on safety and immune responses to ChAdOx1 nCoV-19
Differences reactogenicity profile, antibody titres and T-cell responses between groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.

[Time Frame: 6 months ]
Eligibility
Minimum Age: 5 Years 5 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: YesYes
Criteria:

Inclusion Criteria:

  • Adults aged 18 years or older (groups 4 and 6); aged 18-55 years (group 5)
  • Adults aged 56-69 years (groups 1 and 7)
  • Adults aged 70 years and older (groups 2 and 8)
  • 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

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.
  • 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).
  • 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; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral • 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.
  • Seropositivity to SARS-CoV-2 before enrolment

Additional Exclusion criteria to Groups 4 and 6 • 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

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

Exclusion Criteria:

  • 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)

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

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