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COVID-19Phase 1/2NCT04684446

Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19

A Phase 1/2 study testing AZD1222 and rAd26-S in people with COVID-19, run by R-Pharm at 4 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 130 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
AZD1222 and rAd26-S
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesRussia
Study dates
15 Sep 2021to 29 Mar 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults ≥ 18 years of age at the time of signing the informed consent
  • 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
  • Able to understand and comply with study requirements/procedures based on the assessment of the investigator
  • Reproduction:
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  • Female participants
  • 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.
  • 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.

Who cannot join

  • Medical Conditions
  • Known past laboratory-confirmed SARS-CoV-2 infection.
  • Positive SARS-CoV-2 RT PCR test at screening.
  • Seropositivity to SARS-CoV-2 at screening.
  • 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).
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  • 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

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • OJSC Clinical and Diagnostic Center Euromedservice

    Moscow, 115419

  • LLC PiterClinica

    Saint Petersburg, 196158

  • 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

    Saint Petersburg, 197022

  • Federal State Budget Institution "Scientific and Research Institute of Flu n.a. A.A. Smorodintseva" of Ministry of Health of Russian Federation

    Saint Petersburg, 197376

Other trials in Russia

About this study

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

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.

Conditions
COVID-19
Being tested
AZD1222, rAd26-S
Keywords
COVID-19 Prevention, AZD1222 vaccine, rAd26-S, Sputnik V
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1222Biological

    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

  • rAd26-SBiological

    Also called Sputnik V

    Participants will receive 1 IM injection of rAd26-S on Day 1 followed by AZD1222 on Day 29

Study groups in NCT04684446
Study groupRoleWhat they receive
Arm 1ExperimentalAZD1222 on Day 1 followed by rAd26-S on Day 29
Receives: Biological: AZD1222
Arm 2ExperimentalrAd26-S on Day 1 followed by AZD1222 on Day 29
Receives: Biological: rAd26-S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 neutralising antibodies 29 days post second vaccination.

    Immunogenicity

    Measured: Day 29 through Day 57

  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).

    Safety

    Measured: Day 1 through Day 7 and Day 29 through Day 35

  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).

    Safety

    Measured: 57 days

Secondary outcomes (8)

  1. Incidence of SAEs and AESIs after first vaccination until study end (Day 180).

    Safety

    Measured: 180 days

  2. Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 Spike protein

    Immunogenicity

    Measured: 180 days

  3. Antibody seroconversion rate (≥ 4-fold increase from baseline) against RBD antigen.

    Immunogenicity

    Measured: 180 days

  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).

    Immunogenicity

    Measured: 180 days

  5. Antibody seroconversion rate (≥ 4-fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post first vaccination

    Immunogenicity

    Measured: Day 1 through Day 29

  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).

    Immunogenicity

    Measured: 180 days

  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

    Safety

    Measured: 180 days

  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

    Efficacy

    Measured: Day 29 through Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start15 Sep 2021
  3. Primary completion26 Nov 2021
  4. Study completion29 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04684446
Sponsor's protocol ID
D8111C00003
Status last verified
Jun 2022
First submitted
23 Dec 2020
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD1222 and rAd26-S in people with COVID-19, run by R-Pharm at 4 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04684446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.

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