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Trial record 3 of 34 for:    AZD1222

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

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: NCT05057897
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
COVID-19, SARS-CoV-2 Biological: AZD1222 Phase 4

Detailed Description:
The purpose of this study is to demonstrate the safety and characterize the immunogenicity of AZD1222; AstraZeneca's candidate ChAdOx1 vector vaccine against SARS-CoV-2 (nCoV-19) in previously unvaccinated immunocompromised adults.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Previously unvaccinated immunocompromised adults will be enrolled in 5 disease cohorts of approximately 60 participants each:

  1. Solid organ transplant
  2. Hematopoietic stem cell transplant
  3. Solid organ cancer patients receiving cytotoxic chemotherapy
  4. Chronic inflammatory disorders
  5. 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.

Participants will receive 2 intramuscular doses of AZD1222 separated by 4 weeks and will be followed for 1 year after dose 1.

Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : January 14, 2022
Estimated Primary Completion Date : September 29, 2022
Estimated Study Completion Date : August 22, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Arm Intervention/treatment
2 doses of AZD1222, 4 weeks apart
Previously unvaccinated. First dose administered on Day 1 and second dose on Day 29.
Biological: AZD1222
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 Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


  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


  3. 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

  4. 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

  5. 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 2-dose primary vaccination with AZD1222 with a 4-week dosing interval

  6. 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) ]
    Characterization of the reactogenicity and safety of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval

  7. Incidence of SAEs, MAAEs and AESIs in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years [ Time Frame: From Day 1 post treatment to Day 365 ]
    Characterization of the reactogenicity and safety of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval

  8. Absolute and change from baseline for safety laboratory measures in SARS-CoV-2 naïve immunocompromised adults ≥ 18 years [ Time Frame: During the study ]
    Characterization of the reactogenicity and safety of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval



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:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 RT-PCR.
  3. Known 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.

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): NCT05057897


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Colombia
Research Site
Barranquilla, Colombia, 80001
Research Site
Bucaramanga, Colombia
Research Site
Floridablanca, Colombia, 680006
Egypt
Research Site
Cairo, Egypt, 11566
Research Site
New Cairo, Egypt, 11566
India
Research Site
Ajmer, India, 305001
Research Site
Bangalore, India, 560068
Research Site
Bhubaneswar, India, 751003
Research Site
Faridabad, India, 121012
Research Site
Kolkata, India, 700054
Research Site
New Delhi, India, 110060
Research Site
Pune, India, 411 018
Research Site
Surat, India, 395009
Thailand
Research Site
Bangkok, Thailand, 10330
Research Site
Bangkok, Thailand, 10700
Research Site
Khon Kaen, Thailand, 40002
Research Site
Muang, Thailand, 50200
Turkey
Research Site
Diyarbakir, Turkey, 21280
Research Site
Kayseri, Turkey, 38080
Ukraine
Research Site
Ivano-Frankivsk, Ukraine, 76007
Research Site
Kharkiv, Ukraine, 61052
Research Site
Kyiv, Ukraine, 3126
Research Site
M. Lviv, Ukraine, 79011
Vietnam
Research Site
Hanoi, Vietnam, 100000
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05057897    
Other Study ID Numbers: D8111C00010
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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
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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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 AstraZeneca:
COVID-19 Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases