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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

AZD1222

0.9% (w/v) saline

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Part I

Part II

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of participants who have a post treatment seroresponse to the spike antigens of AZD1222

The primary immunogenicity endpoint is the proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to the Spike antigens of AZD1222 (MSD serology assay) at Day 57 , and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 1 to 8).

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 29 to 36).

The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs)

The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 57.

Biochemistry; change from baseline for blood chemistry measures

The change from baseline for blood chemistry measures (Creatinine in U/L ,Bilirubin in mg/dL, ALP in U/L, AST in U/L, ALT in U/L, Albumin in g/dL, Potassium in mEq/L, Calcium in mg/dL Sodium mEq/L, Creatine Kinase in U/L)

Haematology; change from baseline for hematology/hemostasis measures

The change from baseline for hematology measures (Hb in g/dL, Leukocyte in /uL, Leukocyte differential count in /uL and Platelet count in /uL)

Secondary Outcome Measures

Proportion of participants who have a post treatment

The proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to RBD antigens of AZD1222 (MSD serology assay) at Day 57, and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

Genometric mean titres and genometric mean fold rise

Geometric mean titres and geometric mean fold rise [Time Frame: Day 57 ] Geometric mean titres (GMT) and geometric mean fold rise (GMFR) of immunogenicity to Spike and RBD antigen of AZD1222 (MSD serology assay) with its 95% CI will be computed at each time point in each treatment arm in each cohort (C, and D) and also in Subcohorts D1, and D2 separately.

Proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs

The proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs [Time Frame: Day 57 ] The proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to AZD1222 as measured by SARS-CoV02 nAbs (wild-type assay or pseudoneutralisation assay) at Day 57, and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

The incidence of serious adverse events (SAEs) and adverse events of specisl interest (AESIs) collected from Day1 through Day365

The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 365.

Full Information

NCT ID

NCT04568031

First Posted

August 21, 2020

Last Updated

November 29, 2021

Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04568031

Brief Title

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

Official Title

A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 23, 2020 (Actual)

Primary Completion Date

November 22, 2021 (Actual)

Study Completion Date

November 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19 Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part I

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Part II

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

AZD1222

Intervention Description

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

Intervention Name(s)

0.9% (w/v) saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of participants who have a post treatment seroresponse to the spike antigens of AZD1222

Description

The primary immunogenicity endpoint is the proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to the Spike antigens of AZD1222 (MSD serology assay) at Day 57 , and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

Time Frame

Day 57

Title

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination

Description

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 1 to 8).

Time Frame

Day 1 to 8

Title

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination

Description

The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 29 to 36).

Time Frame

Day 29 to 36

Title

The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs)

Description

The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 57.

Time Frame

Day 1 through Day 57

Title

Biochemistry; change from baseline for blood chemistry measures

Description

The change from baseline for blood chemistry measures (Creatinine in U/L ,Bilirubin in mg/dL, ALP in U/L, AST in U/L, ALT in U/L, Albumin in g/dL, Potassium in mEq/L, Calcium in mg/dL Sodium mEq/L, Creatine Kinase in U/L)

Time Frame

Day 8, Day 29, Day 36, and Day 57

Title

Haematology; change from baseline for hematology/hemostasis measures

Description

The change from baseline for hematology measures (Hb in g/dL, Leukocyte in /uL, Leukocyte differential count in /uL and Platelet count in /uL)

Time Frame

Day 8, Day 29, Day 36, and Day 57

Secondary Outcome Measure Information:

Title

Proportion of participants who have a post treatment

Description

The proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to RBD antigens of AZD1222 (MSD serology assay) at Day 57, and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

Time Frame

Day 57

Title

Genometric mean titres and genometric mean fold rise

Description

Geometric mean titres and geometric mean fold rise [Time Frame: Day 57 ] Geometric mean titres (GMT) and geometric mean fold rise (GMFR) of immunogenicity to Spike and RBD antigen of AZD1222 (MSD serology assay) with its 95% CI will be computed at each time point in each treatment arm in each cohort (C, and D) and also in Subcohorts D1, and D2 separately.

Time Frame

Day 57

Title

Proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs

Description

The proportion of participants who have a post treatment seroresponse to AZD1222 as measured by SARS-CoV-2 nAbs [Time Frame: Day 57 ] The proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to AZD1222 as measured by SARS-CoV02 nAbs (wild-type assay or pseudoneutralisation assay) at Day 57, and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (C, and D) and also Subcohorts D1, and D2 separately.

Time Frame

Day 57

Title

The incidence of serious adverse events (SAEs) and adverse events of specisl interest (AESIs) collected from Day1 through Day365

Description

The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 365.

Time Frame

Day 1 through Day 365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

810-0021

Country

Japan

Facility Name

Research Site

City

Hachioji-shi

ZIP/Postal Code

192-0046

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

108-0075

Country

Japan

Facility Name

Research Site

City

Sumida-ku

ZIP/Postal Code

130-0004

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

171-0021

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing 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

IPD Sharing 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

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

34688944

Citation

Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, Matsui A, Kelly EJ, Shoemaker K, Olsson U, Vekemans J. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 2021 Oct 22.

Results Reference

derived

COVID-19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial