Study of AZD1222 for the Prevention of COVID-19 in Japan

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-23

Study Completion Date

2021-11-22

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part I

Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years.

Group Type ACTIVE_COMPARATOR

AZD1222

Intervention Type DRUG

For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2

Part II

Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years.

Group Type PLACEBO_COMPARATOR

0.9% (w/v) saline

Intervention Type DRUG

For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.

Interventions

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AZD1222

For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2

Intervention Type DRUG

0.9% (w/v) saline

For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.

Intervention Type DRUG

Eligibility Criteria

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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

1. Known past laboratory-confirmed SARS-CoV-2 infection
2. Positive SARS-CoV-2 RT PCR test at screening
3. Seropositivity to SARS-CoV-2 at screening.
4. Significant infection or other illness, including fever \> 37.8°C on the day prior to or day randomization
5. History of Guillain-Barré syndrome
6. 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)
7. History of allergy to any component of the vaccine
8. Any history of angioedema
9. Any history of anaphylaxis
10. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ)
11. History of serious psychiatric condition likely to affect participation in the study
12. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
13. Suspected or known current alcohol or drug dependency
14. 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
15. 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes