Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
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ClinicalTrials.gov Identifier: NCT04516746 |
Recruitment Status : Not yet recruiting
First Posted : August 18, 2020
Last Update Posted : August 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 SARS-CoV-2 | Biological: AZD1222 Biological: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants are assigned to one of two or more groups in parallel for the duration of the study. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double Blind: two or more parties are unaware of the intervention assignment. |
Primary Purpose: | Treatment |
Official Title: | A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19 |
Estimated Study Start Date : | August 17, 2020 |
Estimated Primary Completion Date : | December 2, 2020 |
Estimated Study Completion Date : | October 5, 2022 |
Arm | Intervention/treatment |
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Experimental: AZD1222
2 IM doses of 5 × 10^10 vp (nominal, ± 1.5 × 10^10 vp) AZD1222 4 weeks apart
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Biological: AZD1222
Participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20,000) or saline placebo (the control group, n = approximately 10 000) 4 weeks apart
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Placebo Comparator: Placebo
2 IM doses of saline placebo 4 weeks apart
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Biological: Placebo
Participants will be randomized in a 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222 (n = approximately 20,000) or saline placebo (the control group, n = approximately 10 000) 4 weeks apart
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- To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age [ Time Frame: 1 year ]
A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs
≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.
- To assess the safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age [ Time Frame: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730. ]
- Incidence of adverse events.
- Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.
- To assess the reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age (Substudy only) [ Time Frame: 7 days post each dose of study intervention. ]
Incidence of local and systemic solicited adverse events.
- To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of SARS-CoV-2 asymptomatic infection [ Time Frame: 1 year ]
Proportion of participants positive for SARS-CoV-2 Nucleocapsid antibodies over time.
- To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of symptomatic COVID-19 using CDC criteria [ Time Frame: 1 year ]
The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using CDC criteria
- To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of University of Oxford defined symptomatic COVID-19 [ Time Frame: 1 year ]
The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford defined symptom criteria
- To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of severe or critical symptomatic COVID-19 [ Time Frame: 1 year ]
The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention.
- To estimate the efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19-related Emergency Department visits [ Time Frame: 1 year ]
The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention
- To assess antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or placebo (Substudy and Illness Visits only) [ Time Frame: 28 days post each dose ]
Post-treatment GMTs and GMFRs in SARS-CoV-2S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)
- To determine anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or placebo (Sub-study and Illness Visits only) [ Time Frame: 28 days post each dose ]
Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Increased risk of SARS-CoV-2 infection
- Medically stable
Exclusion Criteria:
- confirmed or suspected immunosuppressive or immunodeficient state
- significant disease, disorder, or finding
- Prior or concomitant vaccine therapy for COVID-19
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): NCT04516746
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Principal Investigator: | Ann Falsey, MD | University of Rochester | |
Principal Investigator: | Magda Sobieszczyk, MD | Columbia University |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT04516746 |
Other Study ID Numbers: | D8110C00001 |
First Posted: | August 18, 2020 Key Record Dates |
Last Update Posted: | August 18, 2020 |
Last Verified: | August 2020 |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Vaccine |