ClinicalTrials.gov

History of Changes for Study: NCT04400838
Investigating a Vaccine Against COVID-19
Latest version (submitted July 31, 2023) 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
13 October 14, 2021 Study Status and Outcome Measures
14 January 20, 2022 Study Status
15 July 31, 2023 Study Status
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04400838
May 22, 2020 (v1) -- January 20, 2022 (v14)

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

Open or close this module 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:
Open or close this module Study Status
Record Verification: May 2020 January 2022
Overall Status: Not yet recruitingActive, not recruiting
Study Start: May 2020 May 28, 2020
Primary Completion: August 2021 [Anticipated] March 31, 2023 [Anticipated]
Study Completion: August 2021 [Anticipated] March 31, 2023 [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:
May 22, 2020 January 20, 2022
Last Update Posted: May 26, 2020 [Actual] January 21, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oxford University of Oxford
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: NoNo
U.S. FDA-regulated Device: NoNo
Data Monitoring: Yes 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. 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 4 study groups and it is anticipated that a total of 10,260 volunteers will be enrolled. Groups 1 and 2 are adults over the age of 56 and will participate in the study for 6 months with the option to come for an additional follow up visit at day 364. Group 3 is children aged 5-12 years will participate in the study for 6 months with the option to come for an additional follow up visit at day 364. Group 4 is adults over the age of 18 and will participate in the study for 3 months with the option to come for an additional follow up visit at day 182.

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

Open or close this module Conditions
Conditions: Coronavirus Coronavirus
Keywords: Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Open or close this module 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: 1429
Masking: Single (Participant)Single (Participant)
Allocation: RandomizedRandomized
Enrollment: 10260 [Anticipated] 12390 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1 a1 aE
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
Biological: ChAdOx1 nCoV- 19 19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV- 19 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)
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 one dose of MenACWY at week 0 and one dose of MenACWY at week 4 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)
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: MenACWY vaccine + boost
Two standard doses of MenACWY vaccine 4 weeks apart
Other Names:
  • Menveo
  • Nimenrix
Experimental: Group 2 a1
Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
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 bE
Volunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 4 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
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 + boost
Two doses of 5x10^10vp of ChAdOx1 nCoV-19 4 weeks apart
Experimental: Group 2aE 4 a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp (Abs 260)
Biological: ChAdOx1 nCoV- 19 19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV- 19 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
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 2bE 4 c1
Volunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 4 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, 5x10^10vp (Abs260) prime and 2.2x10^10vp (qPCR) boost*, at least 4 weeks apart
Biological: ChAdOx1 nCoV-19 + 0.5mL prime plus boost
Two doses of 5x10^10vp of ChAdOx1 nCoV-19 4 weeks apart Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)
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
Experimental: Group 4E 5 a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp, (Abs 260)
Biological: ChAdOx1 nCoV- 19 19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV- 19 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)
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)
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260
Active Comparator: Group 2bA Experimental: Group 5 d1
Volunteers will receive one dose of MenACWY at week 0 and one dose of MenACWY at week 4 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)* 4-6 weeks apart
Biological: MenACWY vaccine + boost
Two standard doses of MenACWY vaccine 4 weeks apart
Other Names:
  • Menveo
  • Nimenrix
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 3E 5 e1
Volunteers will receive a single dose of 2.5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart
Biological: ChAdox1 n-CoV vaccine low dose Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.5mL
A single dose of 2.5x10^10vp of ChAdOx1 nCoV-19 Two dose ChAdOx1 nCoV-19 0.5mL (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks apart
Experimental: Group 5 f1
Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Biological: Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL
Two dose ChAdOx1 nCoV-19 (Covishield 0.9 x 10^11 vp/mL), 0.25mL prime and 0.5mL boost 4-6 weeks apart
Experimental: Group 6 a1
Volunteers will receive a single dose ofChAdOx1 nCoV19 vaccine, 5x1010vp (qPCR)
Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR
Active Comparator: Group 4A 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)* boost* at least 4 weeks apart
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
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 7 a1
Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)
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, 5x10^10vp (qPCR)* 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)
Experimental: Group 5E 8 a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the MenACWY comparator. Volunteers will receive a single dose ChAdOx1nCOV19 vaccine, 5x10^10vp (qPCR)
Biological: ChAdOx1 nCoV-19
A single dose of 5x10^10vp of ChAdOx1 nCoV-19
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)* 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: Group 5A Experimental: Group 9 a1
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 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)* 4-6 weeks apart
Biological: MenACWY vaccine
Standard single dose of MenACWY vaccine
Other Names:
  • Menveo
  • Nimenrix
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 10 a1
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)
Experimental: Group 11
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)
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, 4 a2, 5 a2, 5 b2, 5 c2, 6 a2, 7 a2 & 8 a2 will receive a standard single dose of MenACWY vaccine
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, 5 d2, 7 b2, 8 b2, 9 a2 & 10 a2 will receive two doses of MenACWY 4-6 weeks apart
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 weeks
Groups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will receive two doses of MenACWY at least 4 weeks apart
Biological: Two dose MenACWY vaccine min. 4 weeks apart
Two standard doses of MenACWY vaccine minimum 4 weeks apart
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 ]

Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
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) ]

Number of virologically confirmed (PCR or NAAT 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 ]

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

Occurrence of disease enhancement episodes
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
[ Time Frame: 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 ]

Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions
[ Time Frame: 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
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
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
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)
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
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 and 3 only)
[ Time Frame: 6 months ]

Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 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 and 2 only): local reactogenicity
[ Time Frame: 7 days post vaccination ]

Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster 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, 2, 7 and 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
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
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)
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)
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
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
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
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
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
4 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
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 or NAAT
[ Time Frame: 6 months ]

Number of PCR or NAAT 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
[ 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 or NAAT positive individuals
[ Time Frame: 6 months ]

Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 PCR or NAAT 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 including immune responses to a further dose administered via the NHS national roll out
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
21. To assess immunological correlates of protection in relation to occurrence of COVID-19 disease in ChAdOx1 nCoV-19 recipients
[ Time Frame: Throughout the study, average of 18 months] ]

Immunological endpoints (antibody & cellular responses to SARS-COV2 spike protein) and COVID-19 disease endpoints (SARS-COV2 PCR positivity plus symptoms) in ChAdOx1 nCoV-19 recipients
Open or close this module Eligibility
Minimum Age: 5 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: YesYes
Criteria:

Inclusion Criteria:

  • Adults aged 56 or older (groups 1 and 2)
  • Adults aged 18 or older (group 4)
  • Children aged 5-12 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:

  • Current or planned participation in other clinical trial of an investigational medicinal product
  • Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrolment
  • Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
  • Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed).
  • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
  • Any history of hereditary angioedema or idiopathic 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.
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
  • History of laboratory confirmed COVID-19.
  • New onset of fever or a cough or shortness of breath since February 2020
  • Those who have been at high risk of exposure before enrolment, including but not limited to: close contacts of confirmed COVID-19 cases, anyone who had to self-isolate as a result of a symptomatic household member, frontline healthcare professionals working in A&E, ICU and other higher risk areas and significant exposure associated with travel abroad to high incidence areas since January 2020.
  • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) Additional Exclusion criteria to Groups 1 and 2
  • Chronic respiratory disease, including asthma
  • Severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild well controlled comorbidities are allowed)
  • Seriously overweight (BMI≥40 Kg/m2)
  • History of auto-immune disease

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)
  • 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.

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 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.
  • 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
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
Andrew Pollard, Prof
Principal Investigator
University of Oxford
Locations: United KingdomUnited Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Contact:Contact: Christopher Green, PhD
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
North Bristol NHS Trust
Bristol, United Kingdom
Contact:Contact: Rajeka Lazarus, DPhil
North Bristol NHS Trust
Bristol, United Kingdom
NIHR Cambridge Clinical Research Facility
Cambridge, United Kingdom, CB2 0QQ
Contact:Contact: Estee Torok, PhD
Contact:Contact: Mark Toshner, PhD
NIHR Cambridge Clinical Research Facility
Cambridge, United Kingdom, CB2 0QQ
Public Health Wales
Cardiff, United Kingdom, CF10 4BQ
Contact:Contact: James Adamson, DPH
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Contact:Contact: Patrick Lillie, PhD
NHS Lothian, Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Contact:Contact: Rebecca Sutherland, MBChB
NHS Lothian, Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
Glasgow, United Kingdom, G31 2ER
Glasgow University and NHS Greater Glasgow & Clyde, New Lister Building, Glasgow Royal Infirmary & Queen Elizabeth University Hospital
Glasgow, United Kingdom, G31 2ER
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
LIverpool, United Kingdom, L7 8XZ
Liverpool School of Tropical Medicine (LSTM), Accelerator Research Clinic. Clinical Sciences Accelerator
LIverpool, United Kingdom, L7 8XZ
London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
London, United Kingdom, HA1 3UJ
Contact:Contact: Alistair McGregor, DTM&H
London North West University Healthcare Trust (LNWUH), Northwick Park Hospital
London, United Kingdom, HA1 3UJ
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
London, United Kingdom, SE1 7EH
Contact:Contact: Anna Goodman, DPhil
Guy's and St Thomas' NHS Foundation Trust, Department of Infection, St Thomas Hospital
London, United Kingdom, SE1 7EH
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Public Health Wales
Newport, United Kingdom, NP18 3XQ
University of Nottingham Health Service, Cripps Health Centre, University Park
Nottingham, United Kingdom, NG7 2QW
University of Nottingham Health Service, Cripps Health Centre, University Park
Nottingham, United Kingdom, NG7 2QW
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Contact:Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2RX
Contact:Contact: Thomas Darton, PhD
Sheffield Teaching Hospitals, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2RX
United Kingdom, HampshireUnited Kingdom, Hampshire
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact:Contact: Study Coodinator UHS.RecruitmentCRF@nhs.net
Contact:Principal Investigator: Saul Faust, PhD
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
United Kingdom, Hull
Castle Hill Hospital
Cottingham, Hull, United Kingdom, HU16 5JQ
United Kingdom, TootingUnited Kingdom, Tooting
St Georges University Hospital NHS Foundation Trust
London, Tooting, United Kingdom, SW17 0QT
St Georges University Hospital NHS Foundation Trust
London, Tooting, United Kingdom, SW17 0QT
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