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AstraZeneca Vax - Sputnik V Combination Study

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 : Not yet recruiting
First Posted : December 24, 2020
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
R-Pharm
Russian Direct Investment Fund
The Gamaleya National Center of Epidemiology & Microbiology
Information provided by (Responsible Party):
AstraZeneca

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: None (Open Label)
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
Estimated Study Start Date : March 30, 2021
Estimated Primary Completion Date : October 12, 2021
Estimated Study Completion Date : October 12, 2021

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 Spike protein 29 days post second vaccination. [ Time Frame: 29 days ]
    Immunogenicity


Secondary Outcome Measures :
  1. 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: 35 days ]
    Safety

  2. 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

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

  4. Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 Spike protein 29 days post first vaccination. [ Time Frame: 29 days ]
    Immunogenicity

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

  6. 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

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

  8. 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



Information from the National Library of Medicine

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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. Healthy or medically stable
  3. Reproduction:

Female participants of childbearing potential should use appropriate contraception through 60 days following administration of the second dose

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 day of randomisation
  5. Any confirmed or suspected immunosuppressive or immunodeficient state; 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).
  6. History of allergy to any component of the vaccine
  7. Any history of anaphylaxis or angioedema.
  8. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ).
  9. History of serious psychiatric condition likely to affect participation in the study.
  10. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  11. Suspected or known current alcohol or drug dependency.
  12. History of Guillan-Barré syndrome or any other demyelinating condition.
  13. 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.
  14. 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).

    Prior/Concomitant Therapy

  15. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination.
  16. 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).
  17. Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the vaccine candidate.
  18. Continuous use of anticoagulants, such as coumarins and related anticoagulants (ie, warfarin) or novel oral anticoagulants (ie, apixaban, rivaroxaban, dabigatran and edoxaban).

    Prior/Concurrent Clinical Study Experience

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

    Other Exclusions

  20. For female subjects only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

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


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

Locations
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Belarus
Research Site
Vitebsk, Belarus, 210037
Russian Federation
Research Site
Moscow, Russian Federation, 109240
Research Site
Moscow, Russian Federation, 115419
Research Site
Moscow, Russian Federation, 121359
Research Site
Saint-Petersburg, Russian Federation, 196158
Research Site
Saint-Petersburg, Russian Federation, 197376
Research Site
St. Petersburg, Russian Federation, 197022
Sponsors and Collaborators
AstraZeneca
R-Pharm
Russian Direct Investment Fund
The Gamaleya National Center of Epidemiology & Microbiology
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04684446    
Other Study ID Numbers: D8111C00003
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 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 AstraZeneca:
COVID-19 Prevention
AZD1222 vaccine
rAd26-S
Sputnik V