Phase 3 N=32,450 Randomized Quadruple-blind Treatment

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

COVID-19 · SARS-CoV-2

Bottom Line

View on ClinicalTrials.gov: NCT04516746 ↗

Enrolled (actual)

32,450

Serious AEs

4.7%

Results posted

Apr 2022

Primary outcome: Primary: Number of Participants With Binary Response — 73; 130 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AZD1222 (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Binary Response	73; 130	<0.001 sig
PRIMARY Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention	5736; 1926; 5074; 1797; 8771; 3201	—
PRIMARY Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Prior to Non-study COVID-19 Vaccination	621; 136; 4750; 1256; 2516; 591	—
PRIMARY Number of Participants With Local and Systemic Solicited AEs in the Substudy Only	1250; 173; 977; 120; 1440; 239	—
SECONDARY Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study Intervention	156; 202	<0.001 sig
SECONDARY Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention	95; 145	<0.001 sig
SECONDARY Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention	86; 136	<0.001 sig
SECONDARY Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention	76; 135	<0.001 sig
SECONDARY Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention	0; 8	<0.001 sig
SECONDARY Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention	5; 16	<0.001 sig
SECONDARY Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention	1; 9	0.005 sig
SECONDARY Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay	53.18; 54.68; 1820.10; 53.47; 5782.09; 53.64	—
SECONDARY Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay	34.28; 0.97; 108.35; 0.92; 455.38; 1.08	—
SECONDARY Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay	89.8; 1.1; 97.1; 1.6; 99.4; 2.5	—
SECONDARY GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay	20.6; 21.4; 41.7; 21.7; 65.9; 23.0	—
SECONDARY GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay	2.03; 1.01; 3.24; 1.07; 10.91; 1.05	—
SECONDARY Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay	24.8; 0.3; 41.1; 1.8; 84.4; 1.9	—
SECONDARY Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention	287; 303	—

Summary

The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04516746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.