Phase 2
N=256
Study of AZD1222 for the Prevention of COVID-19 in Japan
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04568031 ↗Enrolled (actual)
256
Serious AEs
2.3%
Results posted
Mar 2024
Primary outcome: Primary: Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay — 100.0; 0.0; 100.0; 0.0 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD1222 (Drug); 0.9% (w/v) saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay |
100.0; 0.0; 100.0; 0.0 | < 0.001 sig |
| PRIMARY Number of Participants With Local Solicited Adverse Events (AE) |
70; 4; 46; 2; 37; 3 | — |
| PRIMARY Number of Participants With Systemic Solicited AEs |
65; 6; 41; 3; 30; 7 | — |
| PRIMARY Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination |
28; 4; 22; 9; 0; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay |
100.0; 0.0; 100.0; 0.0 | < 0.001 sig |
| SECONDARY Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay |
62.18; 46.00; 39.06; 39.87; 2520.37; 43.70 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay |
40.54; 0.95; 25.59; 0.98; 128.20; 0.93 | — |
| SECONDARY Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay |
67.5; 0.0; 57.0; 0.0 | < 0.001 sig |
| SECONDARY GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay |
20.84; 20.00; 20.00; 20.82; 67.26; 20.00 | — |
| SECONDARY GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay |
3.21; 1.00; 2.31; 1.01; 5.14; 1.00 | — |
| SECONDARY Number of Participants With SAEs and AESIs Occurring Throughout the Study |
0; 2; 3; 1; 0; 1 | — |
Summary
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
Eligibility Criteria
Inclusion Criteria
- Participants aged 18 to 55 years (Cohort A and C), aged 56 to 69 years (Subcohorts B1 and D1), or aged ≥ 70 years (Subcohorts B2 and D2)
Exclusion Criteria
- 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 day randomization
- History of Guillain-Barré syndrome
- Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)
- History of allergy to any component of the vaccine
- Any history of angioedema
- Any history of anaphylaxis
- Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ)
- History of serious psychiatric condition likely to affect participation in the study
- Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- Suspected or known current alcohol or drug dependency
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT04568031). 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.