Clinical trial NCT04568031: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: COVID-19 Vaccine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2020-09-29
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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:

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)

Primary outcomes:
measure: Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay
timeFrame: Baseline (Day 1) and Day 57
measure: Number of Participants With Local Solicited Adverse Events (AE)
timeFrame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
measure: Number of Participants With Systemic Solicited AEs
timeFrame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
measure: Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination
timeFrame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
measure: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
timeFrame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
Secondary outcomes:
measure: Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay
timeFrame: Baseline (Day 1) and Day 57
measure: Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
timeFrame: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
measure: Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
timeFrame: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
measure: Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay
timeFrame: Baseline (Day 1) and Day 57
measure: GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
timeFrame: Baseline (Day 1) and Days 29, 57, 183, and 365
measure: GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
timeFrame: Baseline (Day 1) and Days 29, 57, 183, and 365
measure: Number of Participants With SAEs and AESIs Occurring Throughout the Study
timeFrame: From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Hachioji-shi
country: Japan
facility: Research Site
city: Minato-ku
country: Japan
facility: Research Site
city: Sumida-ku
country: Japan
facility: Research Site
city: Toshima-ku
country: Japan
facility: Research Site
Study officials:
References:
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.