A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults (VICTORIA)

May 19, 2023 updated by: AstraZeneca

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

The aim of this study is to assess the immunogenicity and safety of AZD1222 for prevention of COVID-19 in immunocompromised adults.

Study Overview

Status

Terminated

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangkok, Thailand, 10700
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Kharkiv, Ukraine, 61052
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adult, ≥ 18 years at the time of signing the informed consent.
  2. 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:

  1. History of allergic disease or reactions likely to be exacerbated by any component of AZD1222.
  2. Active infection with SARS-CoV-2 as confirmed locally by nucleic acid amplification test (e.g. RT-PCR).
  3. Known current or past laboratory-confirmed SARS-CoV-2 infection.
  4. Significant infection or other acute illness, including fever (temperature > 37.8°C) on the day prior to or day of first dosing.
  5. Thrombocytopenia with platelet count ≤ 75,000 x 109/microliter based on complete blood count test at screening visit.
  6. HIV-positive participants based on a positive ELISA test performed at screening visit.
  7. History of cerebral venous sinus thrombosis (CVST).
  8. Receipt of any vaccine (licensed or investigational) within 30 days prior to and after administration of AZD1222.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort 1 - immunocompromised participants with solid organ transplant
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.
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
Other: Cohort 2 - immunocompromised participants with hematopoietic stem cell transplant
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.
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
Other: Cohort 3 - immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy
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.
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
Other: Cohort 4 - immunocompromised participants with chronic inflammatory disorders
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.
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
Other: Cohort 5 - immunocompromised participants with primary immunodeficiency
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.
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
Other: Cohort 6 - immunocompetent participants
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 specific titres in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years
Time Frame: 28 days after dosing
Characterization of immunogenicity of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval
28 days after dosing
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
Time Frame: 28 days after dosing
Characterization of immunogenicity of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval
28 days after dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 28 days after Dose 2
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222
28 days after Dose 2
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
Time Frame: 28 days after Dose 2
Description of the immunogenicity of a 2-dose primary vaccination with AZD1222, with a difference of ≥ 4-fold rise in titres from baseline
28 days after Dose 2
Incidence of local and systemic solicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Time Frame: For 7 days after each dose of AZD1222
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
For 7 days after each dose of AZD1222
Incidence of unsolicited AEs after dosing in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
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
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
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
Incidence of SAEs, MAAEs and AESIs in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Time Frame: From Day 1 post treatment to the last study visit
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
From Day 1 post treatment to the last study visit
Absolute and change from baseline for safety laboratory measures in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years
Time Frame: Through 28 days after 3rd dose
Characterization of the reactogenicity and safety of a 3-dose primary vaccination series with AZD1222 with a 4-week dosing interval
Through 28 days after 3rd dose
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
Time Frame: 28 days after Dose 2

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

28 days after Dose 2
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
Time Frame: 28 days after Dose 2

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

28 days after Dose 2
SARS-CoV-2 specific titres in immunocompromised adults ≥ 18 years
Time Frame: 28 days after Dose 3
Characterization of immunogenicity after a 3rd-dose in a 3 dose primary vaccination series with AZD1222
28 days after Dose 3
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in immunocompromised adults ≥ 18 years
Time Frame: 28 days after Dose 3
Characterization of immunogenicity after a 3rd-dose in a 3 dose primary vaccination series with AZD1222
28 days after Dose 3
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
Time Frame: 28 days after Dose 3 (28 Days after Dose 2 for reference cohort)

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

28 days after Dose 3 (28 Days after Dose 2 for reference cohort)
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
Time Frame: 28 days after Dose 3 (28 Days after Dose 2 for reference cohort)

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

28 days after Dose 3 (28 Days after Dose 2 for reference cohort)
Ratio of SARS-CoV-2 specific GMT titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised and immunocompetent participants
Time Frame: 28 Days after Dose 2 and 28 Days after Dose 3
Description of immunogenicity of the AZD1222 vaccination between 28 days post second dose compared to 28 days post third dose
28 Days after Dose 2 and 28 Days after Dose 3
Difference in seroresponse rates of SARS-CoV-2 specific titres in adults ≥ 18 years between SARS-CoV-2 naïve immunocompromised and immunocompetent participants
Time Frame: 28 Days after Dose 2 and 28 Days after Dose 3
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
28 Days after Dose 2 and 28 Days after Dose 3
SARS-CoV-2 specific titres in immunocompetent adults ≥ 18 years
Time Frame: 28 days after Dose 3
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
28 days after Dose 3
Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in immunocompetent adults ≥ 18 years
Time Frame: 28 days after Dose 3
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
28 days after Dose 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

April 19, 2023

Study Completion (Actual)

April 19, 2023

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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