AstraZeneca Vax – Sputnik V Combination Study

Recruitment Status:
Not yet recruiting

Sponsor:
AstraZeneca

Collaborator:
R-Pharm
The Russian Direct Investment Fund (RDIF)
The Gamaleya National Center of Epidemiology & Microbiology

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04684446

Verification:
Verified 01 June 2021   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

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.

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
Study Type:Interventional
Overall Recruitment Status:Not yet recruiting
Study Start Date:31 August 2021
Study Start Date Type:Anticipated
Primary Completion Date:08 April 2022
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
ConditionInterventionPhase
COVID-19
Biological/Vaccine: AZD1222
Biological/Vaccine: rAd26-S
Phase 1/Phase 2
Ages Eligible for Study: 18 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
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.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    [email protected]  

Sponsors and Collaborators

AstraZeneca
R-Pharm
The Russian Direct Investment Fund (RDIF)
The Gamaleya National Center of Epidemiology & Microbiology


Locations

CountryLocationFacilityContactStatus
Russian FederationResearch Site Moscow, Russian Federation, 115419Not Yet Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 109240Not Yet Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 121359Not Yet Recruiting
Russian FederationResearch Site Saint-Petersburg, Russian Federation, 197376Not Yet Recruiting
Russian FederationResearch Site Saint-Petersburg, Russian Federation, 196158Not Yet Recruiting
Russian FederationResearch Site St. Petersburg, Russian Federation, 197022Not Yet Recruiting
BelarusResearch Site Vitebsk, Belarus, 210037Not Yet Recruiting

No attachments posted.

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Purpose

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.

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
Study Type:Interventional
Overall Recruitment Status:Not yet recruiting
Study Start Date:31 August 2021
Study Start Date Type:Anticipated
Primary Completion Date:08 April 2022
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
ConditionInterventionPhase
COVID-19
Biological/Vaccine: AZD1222
Biological/Vaccine: rAd26-S
Phase 1/Phase 2
Ages Eligible for Study: 18 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
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.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    [email protected]  

Sponsors and Collaborators

AstraZeneca
R-Pharm
The Russian Direct Investment Fund (RDIF)
The Gamaleya National Center of Epidemiology & Microbiology


Locations

CountryLocationFacilityContactStatus
Russian FederationResearch Site Moscow, Russian Federation, 115419Not Yet Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 109240Not Yet Recruiting
Russian FederationResearch Site Moscow, Russian Federation, 121359Not Yet Recruiting
Russian FederationResearch Site Saint-Petersburg, Russian Federation, 197376Not Yet Recruiting
Russian FederationResearch Site Saint-Petersburg, Russian Federation, 196158Not Yet Recruiting
Russian FederationResearch Site St. Petersburg, Russian Federation, 197022Not Yet Recruiting
BelarusResearch Site Vitebsk, Belarus, 210037Not Yet Recruiting

Oversight


Is FDA regulated intervention: No 
Is IND/IDE protocol: No 
U.S. FDA-regulated Drug: No 
U.S. FDA-regulated Device: No 

More Information


No publications provided

Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04684446
Other Study ID Numbers:D8111C00003

Keywords provided by AstraZeneca
COVID-19 Prevention
AZD1222 vaccine
rAd26-S
Sputnik V

Additional Relevant MeSH terms:
COVID-19

Primary Outcome Measures:

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

Secondary Outcome Measures:

  • 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 ] [ Designated as safety issue:  ]
    Safety

  • 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 ] [ Designated as safety issue:  ]
    Safety

  • Incidence of SAEs and AESIs after first vaccination until study end (Day 180). [ Time Frame: 180 days ] [ Designated as safety issue:  ]
    Safety

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

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

  • 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 ] [ Designated as safety issue:  ]
    Immunogenicity

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

  • 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 ] [ Designated as safety issue:  ]
    Immunogenicity

Other Pre-specified Outcome Measures:

  • [ Time Frame:  ] [ Designated as safety issue:  ]

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