Back to resultsA Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults (VICTORIA)
Primary Purpose
COVID-19, SARS-CoV-2
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
AZD1222
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19, SARS-CoV-2 focused on measuring COVID-19 Vaccine
Eligibility Criteria
Inclusion Criteria:
- Adult, ≥ 18 years at the time of signing the informed consent.
- Cohort specific inclusion criteria:
Solid organ transplant
- Participants with heart, lung, kidney, or liver transplant, and are stable on immunosuppressants (defined as no change in dose in the previous 4 weeks).
Hematopoietic stem cell transplant
- Participants with autologous (up to 6 months after transplantation) or allogeneic stem cell transplant who are immunosuppressed, with no evidence of active graft-versushost disease, at least one month after the procedure.
Cancer patients on chemotherapy
- Participants with solid tumors (except breast cancer), histologically diagnosed, who were undergoing intravenous cytotoxic chemotherapy within the last 6 months, who received at least 1 cycle prior to cytotoxic chemotherapy, and have a life expectancy of longer than 3 months.
Chronic inflammatory conditions
- Participants with chronic inflammatory conditions, including those on immunosuppressant medications, can be recruited. The following conditions are specifically excluded: multiple sclerosis and peripheral demyelinating disease.
Primary immune deficiency
- Examples include combined granulomatous disorder, SCID, common variable immunodeficiency.
Immunocompetent:
- No confirmed or suspected immunosuppressive or immunodeficient state.
- No use of immunosuppressant medication within the past 1 month (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of AZD1222). The following exceptions are permitted: topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days).
- No receipt of immunoglobulins and/or any blood products within 3 months prior to administration of AZD1222 or expected receipt during the period of study follow up.
- No severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the Investigator.
Exclusion Criteria:
- History of allergic disease or reactions likely to be exacerbated by any component of AZD1222.
- Active infection with SARS-CoV-2 as confirmed locally by nucleic acid amplification test (e.g. RT-PCR).
- Known current or past laboratory-confirmed SARS-CoV-2 infection.
- Significant infection or other acute illness, including fever (temperature > 37.8°C) on the day prior to or day of first dosing.
- Thrombocytopenia with platelet count ≤ 75,000 x 109/microliter based on complete blood count test at screening visit.
- HIV-positive participants based on a positive ELISA test performed at screening visit.
- History of cerebral venous sinus thrombosis (CVST).
- Receipt of any vaccine (licensed or investigational) within 30 days prior to and after administration of AZD1222.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
Cohort 1 - immunocompromised participants with solid organ transplant
Cohort 2 - immunocompromised participants with hematopoietic stem cell transplant
Cohort 3 - immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy
Cohort 4 - immunocompromised participants with chronic inflammatory disorders
Cohort 5 - immunocompromised participants with primary immunodeficiency
Cohort 6 - immunocompetent participants
Arm Description
Previously unvaccinated immunocompromised participants with solid organ transplant will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Previously unvaccinated immunocompromised participants with hematopoietic stem cell transplant will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Previously unvaccinated immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Previously unvaccinated immunocompromised participants with chronic inflammatory disorders will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Previously unvaccinated immunocompromised participants with primary immunodeficiency will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Previously unvaccinated immunocompetent participants will receive a primary vaccination series with 2 IM doses of AZD1222 separated by 4 weeks, followed by a booster dose of AZD1222 administered 6 months after the first dose. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1. Participants will receive a third dose booster 6 months after dose 1 and will continue to be followed to the end of the study.
Outcomes
Primary Outcome Measures
SARS-CoV-2 specific titres in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years
Characterization of immunogenicity of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years
Characterization of immunogenicity of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval
Secondary Outcome Measures
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants with any immunocompromised condition compared to immunocompetent participants
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants with any immunocompromised condition compared to immunocompetent participants
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222, with a difference of ≥ 4-fold rise in titres from baseline
Incidence of local and systemic solicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Incidence of unsolicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Incidence of SAEs, MAAEs and AESIs in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Absolute and change from baseline for safety laboratory measures in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants in the comparator cohort as compared with immunocompetent participants
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222
Comparator cohorts:
solid organ transplant/hematopoietic stem cell transplant/solid organ cancer patients receiving cytotoxic chemotherapy/chronic inflammatory disorders/primary immunodeficiency
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants in the comparator cohort as compared with immunocompetent participants
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222, with a difference of ≥ 4-fold rise in titres from baseline
Comparator cohorts:
solid organ transplant/hematopoietic stem cell transplant/solid organ cancer patients receiving cytotoxic chemotherapy/chronic inflammatory disorders/primary immunodeficiency
SARS-CoV-2 specific titres in immunocompromised adults ≥ 18 years
Characterization of immunogenicity after a 3rd-dose in a 3 dose primary vaccination series with AZD1222
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in immunocompromised adults ≥ 18 years
Characterization of immunogenicity after a 3rd-dose in a 3 dose primary vaccination series with AZD1222
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised participants compared to immunocompetent participants after a 2-dose primary vaccination
Description of immunogenicity after the 3rd dose in a 3-dose primary vaccination with AZD1222
Comparator cohort:
Each of 5 immunocompromised cohorts and pooled immunocompromised cohorts
Reference cohort:
Immunocompetent
Difference in seroresponse rate of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised participants compared to immunocompetent participants after a 2-dose primary vaccination
Description of immunogenicity after the 3rd dose in a 3-dose primary vaccination with AZD1222 with a difference of ≥ 4-fold rise in titres from baseline
Comparator cohort:
Each of 5 immunocompromised cohorts and pooled immunocompromised cohorts
Reference cohort:
Immunocompetent
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised and immunocompetent participants
Description of immunogenicity of the AZD1222 vaccination between 28 days post second dose compared to 28 days post third dose
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised and immunocompetent participants
Description of immunogenicity of the AZD1222 vaccination between 28 days post second dose compared to 28 days post third dose with a difference of ≥ 4 fold increase in titres from 28 days post dose 2 to 28 days post dose 3
SARS-CoV-2 specific titres in immunocompetent adults ≥ 18 years
Characterization of the immunogenicity after a third-dose booster vaccination of AZD1222, administered 6 months after dose 1 of a 2-dose primary vaccination with AZD1222
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in immunocompetent adults ≥ 18 years
Characterization of the immunogenicity after a third-dose booster vaccination of AZD1222, administered 6 months after dose 1 of a 2-dose primary vaccination with AZD1222
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05057897
Brief Title
A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults
Acronym
VICTORIA
Official Title
A Phase IV Open-Label, Non-Randomized, Multi-Cohort, Multicenter Study in Previously Unvaccinated Immunocompromised Adults to Determine the Immunogenicity and Safety of AZD1222 Vaccine for the Prevention of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Removal of the commitment for Immune compromised study (D81111C00010) due to recruitment challenges.
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
April 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the immunogenicity and safety of AZD1222 for prevention of COVID-19 in immunocompromised adults.
Detailed Description
The purpose of this study is to demonstrate the immunogenicity and safety of AZD1222, AstraZeneca's approved ChAdOx1 vector vaccine against SARS-CoV-2, in SARS-CoV-2 seronegative immunocompromised individuals who are unvaccinated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
COVID-19 Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Previously unvaccinated immunocompromised adults will be enrolled in 5 disease cohorts of approximately 60 participants each:
Solid organ transplant
Hematopoietic stem cell transplant
Solid organ cancer patients receiving cytotoxic chemotherapy
Chronic inflammatory disorders
Primary immunodeficiency A sixth cohort of immunocompetent individuals will also be recruited. Participants will be allocated to the immunocompromised cohorts according to the underlying aetiology of their immunocompromised status.
Immunocompromised participants will receive a third dose (primary vaccination series) 4 weeks or more after dose 2 with AZD1222 and will continue to be followed to the end of the study. Immunocompetent participants will be eligible to receive a third dose booster 6 months after dose 1 and will continue to be followed to the end of the study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 - immunocompromised participants with solid organ transplant
Arm Type
Other
Arm Description
Previously unvaccinated immunocompromised participants with solid organ transplant will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Arm Title
Cohort 2 - immunocompromised participants with hematopoietic stem cell transplant
Arm Type
Other
Arm Description
Previously unvaccinated immunocompromised participants with hematopoietic stem cell transplant will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Arm Title
Cohort 3 - immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy
Arm Type
Other
Arm Description
Previously unvaccinated immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Arm Title
Cohort 4 - immunocompromised participants with chronic inflammatory disorders
Arm Type
Other
Arm Description
Previously unvaccinated immunocompromised participants with chronic inflammatory disorders will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Arm Title
Cohort 5 - immunocompromised participants with primary immunodeficiency
Arm Type
Other
Arm Description
Previously unvaccinated immunocompromised participants with primary immunodeficiency will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2.
Arm Title
Cohort 6 - immunocompetent participants
Arm Type
Other
Arm Description
Previously unvaccinated immunocompetent participants will receive a primary vaccination series with 2 IM doses of AZD1222 separated by 4 weeks, followed by a booster dose of AZD1222 administered 6 months after the first dose. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1. Participants will receive a third dose booster 6 months after dose 1 and will continue to be followed to the end of the study.
Intervention Type
Biological
Intervention Name(s)
AZD1222
Intervention Description
10 mM histidine, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6
Primary Outcome Measure Information:
Title
SARS-CoV-2 specific titres in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years
Description
Characterization of immunogenicity of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval
Time Frame
28 days after dosing
Title
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years
Description
Characterization of immunogenicity of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval
Time Frame
28 days after dosing
Secondary Outcome Measure Information:
Title
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants with any immunocompromised condition compared to immunocompetent participants
Description
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222
Time Frame
28 days after Dose 2
Title
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants with any immunocompromised condition compared to immunocompetent participants
Description
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222, with a difference of ≥ 4-fold rise in titres from baseline
Time Frame
28 days after Dose 2
Title
Incidence of local and systemic solicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Description
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Time Frame
For 7 days after each dose of AZD1222
Title
Incidence of unsolicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Description
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Time Frame
For 28 days post dose after each vaccination (i.e., until Day 29 following the first vaccination and Day 57 following the second vaccination) and Day 85 following the 3rd vaccination
Title
Incidence of SAEs, MAAEs and AESIs in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Description
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Time Frame
From Day 1 post treatment to the last study visit
Title
Absolute and change from baseline for safety laboratory measures in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Description
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Time Frame
Through 28 days after 3rd dose
Title
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants in the comparator cohort as compared with immunocompetent participants
Description
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222
Comparator cohorts:
solid organ transplant/hematopoietic stem cell transplant/solid organ cancer patients receiving cytotoxic chemotherapy/chronic inflammatory disorders/primary immunodeficiency
Time Frame
28 days after Dose 2
Title
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years with a 4-week dosing interval between SARS-CoV-2 naïve participants in the comparator cohort as compared with immunocompetent participants
Description
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222, with a difference of ≥ 4-fold rise in titres from baseline
Comparator cohorts:
solid organ transplant/hematopoietic stem cell transplant/solid organ cancer patients receiving cytotoxic chemotherapy/chronic inflammatory disorders/primary immunodeficiency
Time Frame
28 days after Dose 2
Title
SARS-CoV-2 specific titres in immunocompromised adults ≥ 18 years
Description
Characterization of immunogenicity after a 3rd-dose in a 3 dose primary vaccination series with AZD1222
Time Frame
28 days after Dose 3
Title
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in immunocompromised adults ≥ 18 years
Description
Characterization of immunogenicity after a 3rd-dose in a 3 dose primary vaccination series with AZD1222
Time Frame
28 days after Dose 3
Title
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised participants compared to immunocompetent participants after a 2-dose primary vaccination
Description
Description of immunogenicity after the 3rd dose in a 3-dose primary vaccination with AZD1222
Comparator cohort:
Each of 5 immunocompromised cohorts and pooled immunocompromised cohorts
Reference cohort:
Immunocompetent
Time Frame
28 days after Dose 3 (28 Days after Dose 2 for reference cohort)
Title
Difference in seroresponse rate of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised participants compared to immunocompetent participants after a 2-dose primary vaccination
Description
Description of immunogenicity after the 3rd dose in a 3-dose primary vaccination with AZD1222 with a difference of ≥ 4-fold rise in titres from baseline
Comparator cohort:
Each of 5 immunocompromised cohorts and pooled immunocompromised cohorts
Reference cohort:
Immunocompetent
Time Frame
28 days after Dose 3 (28 Days after Dose 2 for reference cohort)
Title
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised and immunocompetent participants
Description
Description of immunogenicity of the AZD1222 vaccination between 28 days post second dose compared to 28 days post third dose
Time Frame
28 Days after Dose 2 and 28 Days after Dose 3
Title
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised and immunocompetent participants
Description
Description of immunogenicity of the AZD1222 vaccination between 28 days post second dose compared to 28 days post third dose with a difference of ≥ 4 fold increase in titres from 28 days post dose 2 to 28 days post dose 3
Time Frame
28 Days after Dose 2 and 28 Days after Dose 3
Title
SARS-CoV-2 specific titres in immunocompetent adults ≥ 18 years
Description
Characterization of the immunogenicity after a third-dose booster vaccination of AZD1222, administered 6 months after dose 1 of a 2-dose primary vaccination with AZD1222
Time Frame
28 days after Dose 3
Title
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in immunocompetent adults ≥ 18 years
Description
Characterization of the immunogenicity after a third-dose booster vaccination of AZD1222, administered 6 months after dose 1 of a 2-dose primary vaccination with AZD1222
Time Frame
28 days after Dose 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult, ≥ 18 years at the time of signing the informed consent.
Cohort specific inclusion criteria:
Solid organ transplant
Participants with heart, lung, kidney, or liver transplant, and are stable on immunosuppressants (defined as no change in dose in the previous 4 weeks).
Hematopoietic stem cell transplant
Participants with autologous (up to 6 months after transplantation) or allogeneic stem cell transplant who are immunosuppressed, with no evidence of active graft-versushost disease, at least one month after the procedure.
Cancer patients on chemotherapy
Participants with solid tumors (except breast cancer), histologically diagnosed, who were undergoing intravenous cytotoxic chemotherapy within the last 6 months, who received at least 1 cycle prior to cytotoxic chemotherapy, and have a life expectancy of longer than 3 months.
Chronic inflammatory conditions
Participants with chronic inflammatory conditions, including those on immunosuppressant medications, can be recruited. The following conditions are specifically excluded: multiple sclerosis and peripheral demyelinating disease.
Primary immune deficiency
Examples include combined granulomatous disorder, SCID, common variable immunodeficiency.
Immunocompetent:
No confirmed or suspected immunosuppressive or immunodeficient state.
No use of immunosuppressant medication within the past 1 month (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of AZD1222). The following exceptions are permitted: topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days).
No receipt of immunoglobulins and/or any blood products within 3 months prior to administration of AZD1222 or expected receipt during the period of study follow up.
No severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the Investigator.
Exclusion Criteria:
History of allergic disease or reactions likely to be exacerbated by any component of AZD1222.
Active infection with SARS-CoV-2 as confirmed locally by nucleic acid amplification test (e.g. RT-PCR).
Known current or past laboratory-confirmed SARS-CoV-2 infection.
Significant infection or other acute illness, including fever (temperature > 37.8°C) on the day prior to or day of first dosing.
Thrombocytopenia with platelet count ≤ 75,000 x 109/microliter based on complete blood count test at screening visit.
HIV-positive participants based on a positive ELISA test performed at screening visit.
History of cerebral venous sinus thrombosis (CVST).
Receipt of any vaccine (licensed or investigational) within 30 days prior to and after administration of AZD1222.
Facility Information:
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61052
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults
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