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Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of 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: NCT04684446
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : September 21, 2021
Sponsor:
Collaborators:
AstraZeneca
Russian Direct Investment Fund
The Gamaleya National Center of Epidemiology & Microbiology
Information provided by (Responsible Party):
R-Pharm

Brief Summary:
The objective is to evaluate the safety and immunogenicity of AZD1222 given in combination with (either before or after) rAd26-S, for the prevention of COVID 19 in adults ≥ 18 years of age.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AZD1222 Biological: rAd26-S Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single-blinded study
Primary Purpose: Prevention
Official Title: A Phase I/II Single-Blinded Randomized Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of COVID 19
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : April 8, 2022
Estimated Study Completion Date : April 8, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Arm Intervention/treatment
Experimental: Arm 1
AZD1222 on Day 1 followed by rAd26-S on Day 29
Biological: AZD1222
Participants will receive 1 intramuscular (IM) injection of 5 ×1010 viral particles (vp) (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×1011 viral particles (vp) (nominal) on Day 29 of the study

Experimental: Arm 2
rAd26-S on Day 1 followed by AZD1222 on Day 29
Biological: rAd26-S
Participants will receive 1 IM injection of rAd26-S on Day 1 followed by AZD1222 on Day 29
Other Name: Sputnik V




Primary Outcome Measures :
  1. Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 neutralising antibodies 29 days post second vaccination. [ Time Frame: Day 29 through Day 57 ]
    Immunogenicity

  2. Incidence of local and systemic solicited AEs for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination). [ Time Frame: Day 1 through Day 7 and Day 29 through Day 35 ]
    Safety

  3. Incidence of unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination). [ Time Frame: 57 days ]
    Safety


Secondary Outcome Measures :
  1. Incidence of SAEs and AESIs after first vaccination until study end (Day 180). [ Time Frame: 180 days ]
    Safety

  2. Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 Spike protein [ Time Frame: 180 days ]
    Immunogenicity

  3. Antibody seroconversion rate (≥ 4-fold increase from baseline) against RBD antigen. [ Time Frame: 180 days ]
    Immunogenicity

  4. GMT and GMFR of immunogenicity against Spike and RBD antigens (MSD serology assay) at the day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180). [ Time Frame: 180 days ]
    Immunogenicity

  5. Antibody seroconversion rate (≥ 4-fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post first vaccination [ Time Frame: Day 1 through Day 29 ]
    Immunogenicity

  6. GMT and GMFR of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180). [ Time Frame: 180 days ]
    Immunogenicity

  7. Intracellular cytokine staining, including quantification of Th1/Th2 responses, and flow cytometry for B- and T-cell responses from day of dosing baseline to 29 days post each vaccination and until study end [ Time Frame: 180 days ]
    Safety

  8. A binary response, whereby a participant is defined as a COVID-19 case if their illness (virologically confirmed [RT-PCR positive] and symptomatic) occurs [ Time Frame: Day 29 through Day 180 ]
    Efficacy



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. Adults ≥ 18 years of age at the time of signing the informed consent
  2. Overtly healthy as determined by medical evaluation, or

    - Medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up.

    o A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment

  3. Able to understand and comply with study requirements/procedures based on the assessment of the investigator
  4. Reproduction:

Female participants

  1. Women of childbearing potential must:

    • Have a negative pregnancy test on the day of screening and on Day 1
    • Use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.

    Periodic abstinence, the rhythm method, and withdrawal are NOT acceptable methods of contraception.

  2. Women are considered of childbearing potential unless they meet either of the following criteria:

    • Surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or
    • Postmenopausal

      6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

    Exclusion Criteria:

    Medical Conditions

    1. Known past laboratory-confirmed SARS-CoV-2 infection.
    2. Positive SARS-CoV-2 RT PCR test at screening.
    3. Seropositivity to SARS-CoV-2 at screening.
    4. Significant infection or other illness, including fever > 37.8°C on the day prior to or on the day of randomization 5. Thrombocytopenia ≥ Grade 2 (i.e. < 100 000/mm^3) 6. Clinically significant neutropenia (as determined by the investigator). 7. Clinically significant anaemia (as determined by the investigator) 8. Any confirmed or suspected immunosuppressive or immunodeficient state; including human immunodeficiency virus (HIV) infection; asplenia; recurrent severe infections and use of chronic immunosuppressant medication (within the past 6 months(≥ 20 mg/day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to vaccination), except topical/inhaled steroids or short-term oral steroids ( course lasting ≤ 14 days).

    9. History of allergy to any component of the vaccine 10. Any history of anaphylaxis or angioedema. 11. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ).

    12. History of serious psychiatric condition likely to affect participation in the study.

    13. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.

    14 Suspected or known current alcohol or drug dependency. 15 History of Guillan-Barré syndrome or any other demyelinating condition. 16 Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data.

    17 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).

    18. Prior splenectomy 19. History of cerebral venous sinus thrombosis or experienced major venous and/or arterial thrombosis.

    20. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination.

    21. Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (eg, adenovirus vectored vaccines, any coronavirus vaccines).

    22. Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the vaccine candidate.

    23. Continuous use of anticoagulants, such as coumarins and related anticoagulants (ie, warfarin) or novel oral anticoagulants (ie, apixaban, rivaroxaban, dabigatran and edoxaban).

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

    25. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

    26. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

    27. Previous randomisation in the present study 28. For female subjects only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

    29. Unwilling to refrain from blood donation during the course of the study


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): NCT04684446


Locations
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Belarus
Vitebsk Regional Clinical Hospital Not yet recruiting
Vitebsk, Belarus, 210037
Contact: Sergey Pimanov    +375298996852    pimanovs@tut.by   
Russian Federation
Joint-Stock Company "Group of Companies Medsi" Not yet recruiting
Moscow, Russian Federation, 109240
Contact: Irina Shestakova    +79057692071    prof.shestakova@yandex.ru   
OJSC Clinical and Diagnostic Center Euromedservice Recruiting
Moscow, Russian Federation, 115419
Contact: Uruzmag Tomaev    +79683786656    umtomaev@mail.ru   
Research Site Not yet recruiting
Moscow, Russian Federation, 121359
LLC PiterClinica Recruiting
Saint-Petersburg, Russian Federation, 196158
Contact: Tatiana Pak    +79818518150    pte@list.ru   
Federal State Budget Institution "Scientific and Research Institute of Flu n.a. A.A. Smorodintseva" of Ministry of Health of Russian Federation Recruiting
Saint-Petersburg, Russian Federation, 197376
Contact: Dmitry Lioznov    +79219095103    dlioznov@yandex.ru   
Federal State Budgetary Educational Institution of Higher Education " First Saint Petersburg State Medical University named after Academician I. P. Pavlov" of the Ministry of Healthcare of the Russian Federation Recruiting
St. Petersburg, Russian Federation, 197022
Contact: Svetlana Nikolaenko    +79213072831    nikolaenkos@yandex.ru   
Sponsors and Collaborators
R-Pharm
AstraZeneca
Russian Direct Investment Fund
The Gamaleya National Center of Epidemiology & Microbiology
Investigators
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Study Director: Mikhail Samsonov R-Pharm
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Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT04684446    
Other Study ID Numbers: D8111C00003
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 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 Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 R-Pharm:
COVID-19 Prevention
AZD1222 vaccine
rAd26-S
Sputnik V
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