AZD1222 Vaccine for the Prevention of COVID-19

NCT04540393 | Withdrawn Phase 3

• 1 other identifier: D8111C00001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

COVID-19

Keywords

COVID-19 Prevention; AZD1222 vaccine for COVID-19 Prevention

Outcome Measures

Primary Outcomes (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).

  180 days

Secondary Outcomes (8)

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

  180 days

• SARS-CoV-2 antigen-specific antibody levels

  180 days

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

  180 days

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

  180 days

• Quantity of SARS-CoV-2 neutralizing antibodies

  180 days

Study Arms (1)

Arm A

EXPERIMENTAL

Single arm

Biological: AZD1222

Interventions

AZD1222 BIOLOGICAL

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

Arm A

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Iqvia Pty Ltd: collaborator
• Covance: collaborator

Study Sites (4)

Research Site

Moscow, 117321, Russia

Location

Research Site

Saint Petersburg, 196240, Russia

Location

Research Site

Saint Petersburg, 197022, Russia

Location

Research Site

Saint Petersburg, 197376, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 7, 2020
• Study Start: September 2, 2020
• Primary Completion: December 4, 2020
• Study Completion: May 11, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

RU (4)