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COVID-19Phase 3NCT04540393

AZD1222 Vaccine for the Prevention of COVID-19

A Phase 3 study testing AZD1222 in people with COVID-19, run by AstraZeneca at 4 sites in Russia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesRussia
Study dates
2 Sep 2020to 11 May 2022
Phase
Phase 3
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

  • Participant must be ≥ 18 years of age at the time of signing the informed consent.
  • Medically stable such that, according to the judgment of the investigator, hospitalization 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.
  • A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization 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.
  • Male and/or female
  • Female participants
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  • 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 intervention. 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 ophorectomy, or hysterectomy), or
  • Postmenopausal
  • For women aged < 50 years, postmenopausal is defined as having both:
  • A history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and
  • A follicle-stimulating hormone level in the post-menopausal range Until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential
  • For women aged ≥ 50 years, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol

Who cannot join

  • History of allergic disease or reactions likely to be exacerbated by any component of AZD1222.
  • Active infection with SARS-CoV-2 as confirmed by RT-PCR.
  • Known past laboratory-confirmed SARS-CoV-2 infection. Note: Participant's baseline serostatus determined as part of the study will not be used as a basis for exclusion from the study.
  • Significant infection or other acute illness, including fever > 37.8°C on the day prior to or day of first dosing.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg/kg/day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention), except topical/inhaled steroids or short-term oral steroids (course lasting
  • ≤ 14 days).
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  • Note: HIV-positive participants with CD4 counts > 500 for ≥ 12 months and on a stable HIV antiretroviral regimen may be enrolled
  • Note: Topical tacrolimus is allowed if not used within 14 days prior to the day of erolment.
  • History of primary malignancy except for:
  • Malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated uterine cervical carcinoma in situ without evidence of disease
  • Localised prostate cancer
  • Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed).
  • History of Guillain-Barré syndrome, or other neuroimmunological disease.
  • Any other significant disease, disorder, or finding that may significantly increase the risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
  • Receipt of, or planned receipt of investigational products indicated for the treatment or prevention of SARS-CoV-2 or COVID-19. Note: For participants in the study who become hospitalised with COVID-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted.
  • Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention.
  • Receipt of any influenza vaccine (licensed or investigational) within 7 days prior to and after administration of study intervention.
  • Receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up.
  • Involvement in the planning and/or conduct of the study (applies to both Sponsor staff and/or staff at the study site).
  • For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding
  • 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.
  • Previous enrolment in the present study. 5.3 Lifestyle Considerations 1) Participants must follow the contraception requirements 2) Restrictions relating to concomitant medications

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • Research Site

    Moscow, 117321

  • Research Site

    Saint Petersburg, 196240

  • Research Site

    Saint Petersburg, 197022

  • Research Site

    Saint Petersburg, 197376

Other trials in Russia

About this study

Official title: A Phase III Open-label Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

The purpose of this study is to evaluate safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation

Read the detailed description

This is a prospective, multicentre, open-label, non-comparative clinical study, designed to provide data on the use of AZD1222 in the Russian Federation. The protocol is part of the international AstraZeneca program of AZD1222 development with several studies being conducted in the UK, US, Japan, and other countries. This study is intended for registration purposes of AZD1222 in Russia. The study data will complement the data from other pivotal controlled studies conducted in other countries with the Russian participants' data, which is considered the most expedited way to make the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccine available to the Russian Federation for contribution to controlling the current public health crisis.

Conditions
COVID-19
Being tested
AZD1222
Keywords
COVID-19 Prevention, AZD1222 vaccine for COVID-19 Prevention
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 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. Unit dose strength(s) > 0.7 × 1011 vp/mL. Dosage level(s) 5 ×1010 vp (nominal). Route of administration Intramuscular injection

Study groups in NCT04540393
Study groupRoleWhat they receive
Arm AExperimentalSingle arm
Receives: Biological: AZD1222

What is being measured

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

  1. Incidence of SAEs following the first vaccination and throughout the study duration (Day 180) [Safety and Tolerability].

    Occurrence of SAEs following the first vaccination and throughout the study duration (Day 180).

    Measured: 180 days

Secondary outcomes (8)

  1. Incidence of Solicited AEs for 7 following each vaccination [Safety and Tolerability].

    Local and systemic solicited AEs for 7 days following each vaccination. Unsolicited AEs for 28 days following each vaccination.

    Occurrence of AESIs following the first vaccination and throughout the study duration (Day 180).

    Measured: 180 days

  2. SARS-CoV-2 antigen-specific antibody levels

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

  3. The rate of participants seroconverting from negative to positive SARS-CoV-2 S antigen

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

  4. The rate of participants seroconverting from negative to positive SARS-CoV-2 N

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

  5. Quantity of SARS-CoV-2 neutralizing antibodies

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

  6. Count of peripheral blood mononuclear cells (PBMCs)

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

  7. Quantity of seasonal coronavirus antigens

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

  8. Quantity of antibodies to the ChAdOx1vector and the persistence of these antibodies over time

    immunogenicity / serologic responses to AZD1222

    Measured: 180 days

Timeline

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

  1. First posted7 Sep 2020
  2. Study start2 Sep 2020
  3. Primary completion4 Dec 2020 (estimated)
  4. Study completion11 May 2022 (estimated)

Why it stopped: The study was put on hold in September 2020 due to a safety concern in another trial but never restarted. In the meantime our clinical development program now includes a similar study with a different design, which we prefer to complete now.

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 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04540393
Sponsor's protocol ID
D8111C00001
Status last verified
Sep 2021
First submitted
26 Aug 2020
Last updated
1 Oct 2021
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD1222 in people with COVID-19, run by AstraZeneca 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 17 inclusion and 25 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: withdrawn, as of the sponsor's last update on 1 Oct 2021. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence of SAEs following the first vaccination and throughout the study duration (Day 180) [Safety and Tolerability]. (time frame: 180 days). 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 NCT04540393.

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 1 Oct 2021.

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