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Trial record 12 of 41 for:    vaccine | covid-19 | Child

Investigating a Vaccine Against COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400838
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Coronavirus Biological: ChAdOx1 nCoV-19 (Abs 260) Biological: MenACWY vaccine Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Biological: Two dose MenACWY vaccine Biological: ChAdox1 n-CoV-19 (Abs 260) vaccine low dose Biological: ChAdOx1 nCoV-19 (qPCR) Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost Biological: Two dose MenACWY vaccine min. 4 weeks apart Phase 2 Phase 3

Detailed Description:

There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. Groups 1, 7 & 9 are adults aged 56-69 years; groups 2, 8 & 10 are adults 70 years and over; group 3 is children aged 5-12 years inclusive; 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12390 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 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 1 a3
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks from prime
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)

Experimental: Group 1 b1
Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost (4-6 weeks apart)
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later

Experimental: Group 2 a1
Volunteers will receive a single dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260)
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260

Experimental: Group 2 a3
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine: 5x10^10vp (Abs 260) prime and 0.5mL (3.5 - 6.5 × 10^10 vp, Abs 260) boost, minimum 4 weeks apart
Biological: ChAdOx1 nCoV-19 0.5mL prime plus boost
Two dose ChAdOx1 nCoV-19 0.5mL (3.5 - 6.5 × 10^10 vp Abs 260)

Experimental: Group 2 b1
.Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later

Experimental: Group 3
Volunteers will receive a single low dose of 2.5x10^10vp ChAdOx1 nCoV-19 (qPCR)
Biological: ChAdox1 n-CoV-19 (Abs 260) vaccine low dose
A single dose of 2.5x10^10vp of ChAdOx1 nCoV-19 measured by qPCR

Experimental: Group 4 a1
Volunteers will receive a single dose ChAdOx1 nCoV19 vaccine, 5x10^10vp (Abs 260)
Biological: ChAdOx1 nCoV-19 (Abs 260)
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260

Experimental: Group 4 b1
Volunteers will receive two dose ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs 260) prime and 2.2x10^10vp (qPCR) boost 4-6 weeks apart
Biological: ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost
A single dose of 5x10^10vp of ChAdOx1 nCoV-19 measured by spectrophotometry at Abs260 and 2.2x10^10vp ChAdOx1 nCoV-19 boost measured by qPCR 4-6 weeks later

Experimental: Group 4 c1
Volunteers will receive two doses of ChAdOx1 nCOV19 vaccine, 5x10^10vp (Abs260) prime and 2.2x10^10vp (qPCR) boost*, at least 4 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 5 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 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

Experimental: Group 5 d1
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 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

Experimental: Group 6 b1
Volunteers will receive two doses of ChAdOx1 nCoV19 vaccine, 5x1010vp (Abs260) prime and 0.5mL (3.5 - 6.5 × 1010 vp, Abs 260)* boost* at least 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 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 8 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 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)

Experimental: Group 9 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 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, 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
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




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: Study duration (12 months from last vaccination) ]
    Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19

  2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children [ Time Frame: Study duration (12 months from last vaccination) ]
    Occurrence of serious adverse events (SAEs) throughout the study duration.


Secondary Outcome Measures :
  1. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following [ Time Frame: 7 days post vaccination ]
    Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination

  2. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following [ Time Frame: 7 days post vaccination ]
    Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination

  3. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination [ Time Frame: 28 days post vaccination ]
    Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

  4. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests) [ Time Frame: 6 months ]
    Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 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: 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: Study duration (12 months from last vaccination) ]
    Number of hospital admissions associated with COVID-19

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

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

  9. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]
    Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study

  10. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19 [ Time Frame: Study duration (12 months from last vaccination) ]
    Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)

  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)

  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

  13. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 3, 7 and 8 only) [ Time Frame: 6 months ]
    Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

  14. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity [ Time Frame: 7 days post vaccination ]
    Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination

  15. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity [ Time Frame: 7 days post vaccination ]
    Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster 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) [ Time Frame: 28 days post vaccination ]
    Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination

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

  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)

  19. Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) [ Time Frame: 56 days post vaccination ]
    Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination


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

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

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

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

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

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

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

  8. Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002 [ Time Frame: 6 months ]
    Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).

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

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

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

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

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

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

  15. Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults [ Time Frame: 6 months ]

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

    1. Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike protein measured by ELISA.
    2. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
    3. Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike protein responses
    4. Further exploratory immunology

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

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

  18. Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults [ Time Frame: 6 months ]
    Immune responses to ChAdOx1 nCoV-19 (assessed as described above)

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

    Measured by the following:

    1. Occurrence of serious adverse events (SAEs) throughout the study duration
    2. Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
    3. Occurrence of solicited systemic signs and symptoms for 7 days following each vaccination
    4. Occurrence of unsolicited AEs for 28 days following each vaccination

  20. To assess Impact of vaccination on HIV reservoirs [ Time Frame: Study duration (12 months from last vaccination) ]
    Change in Total HIV DNA copies per million CD4 T cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 18 - 55 years (groups 4, 5, 6 and 11)
  • Adults aged 56-69 years (groups 1, 7, and 9)
  • Adults aged 70 years and older (groups 2, 8, and 10)
  • Children aged 5-12 years inclusive (group 3)
  • Able and willing (in the Investigator's opinion) to comply with all study requirements.
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
  • For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.
  • Agreement to refrain from blood donation during the course of the study.
  • Provide written informed consent.
  • Parent/Guardian provides informed consent

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

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

Exclusion Criteria:

• Participation in COVID-19 prophylactic drug trials for the duration of the study.

Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible.

• Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.

Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys

  • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the exception of the licensed seasonal influenza vaccination. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine.
  • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days)
  • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
  • Any history of angioedema.
  • Any history of anaphylaxis.
  • Pregnancy, lactation or willingness/intention to become pregnant during the study.
  • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of serious psychiatric condition likely to affect participation in the study.
  • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
  • Suspected or known current alcohol or drug dependency.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
  • History of laboratory confirmed COVID-19 (except groups 5d, 9, 10 and 11).

    • Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 9, 10 and 11)
    • NB: volunteers with previous PCR positive results are also allowed in groups 9, 10 and 11

Additional Exclusion criteria to Groups 4, 6, 9 and 10 • History of allergic disease or reactions likely to be exacerbated by Paracetamol

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

Additional Exclusion Criteria to Group 3

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

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

  • Anaphylactic reaction following administration of vaccine
  • Pregnancy
  • Any AE that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400838


Contacts
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Contact: Volunteer Recruitment Coordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk

Locations
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Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Andrew Pollard, Prof University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04400838    
Other Study ID Numbers: COV002
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Covid-19
ChAdOx1 nCov19
sars-cov-2
vaccine
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs