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

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ClinicalTrials.gov Identifier: NCT04568031
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE August 21, 2020
First Posted Date  ICMJE September 29, 2020
Last Update Posted Date November 30, 2021
Actual Study Start Date  ICMJE August 23, 2020
Actual Primary Completion Date November 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • Proportion of participants who have a post treatment seroresponse to the spike antigens of AZD1222 [ Time Frame: Day 57 ]
    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 [ Time Frame: Day 1 to 8 ]
    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 [ Time Frame: Day 29 to 36 ]
    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) [ Time Frame: Day 1 through Day 57 ]
    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 [ Time Frame: Day 8, Day 29, Day 36, and Day 57 ]
    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 [ Time Frame: Day 8, Day 29, Day 36, and Day 57 ]
    The change from baseline for hematology measures (Hb in g/dL, Leukocyte in /uL, Leukocyte differential count in /uL and Platelet count in /uL)
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • Proportion of participants who have a post treatment seroresponse [ Time Frame: Day 29 or Day 57 ]
    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 29 (Part I) or Day 57 (Part II), and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (A, B, C, and D) and also Subcohorts B1, B2, D1, and D2 separately.
  • The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination [ Time Frame: Day 1 to 8 ]
    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 [ Time Frame: Day 29 to 36 ]
    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) [ Time Frame: Day 1 through Day 57 ]
    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 [ Time Frame: Day 8, Day 29, Day 36, and Day 57 ]
    The change from baseline for blood chemistry measures (Creatinine, Bilirubin, ALP, AST, ALT, Albumin, Potassium, Calcium, Sodium and Creatine kinase)
  • Haematology; change from baseline for hematology/hemostasis measures [ Time Frame: Day 8, Day 29, Day 36, and Day 57 ]
    The change from baseline for hematology measures (Hb, Leukocyte, Leukocyte differential count and Platelet count)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • Proportion of participants who have a post treatment [ 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 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 [ Time Frame: Day 57 ]
    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 [ Time Frame: Day 57 ]
    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 [ Time Frame: Day 1 through Day 365 ]
    The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 365.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
Geometric mean titres [ Time Frame: Day 29 or Day 57 ]
Geometric mean titres (GMT) of immunogenicity to Spike antigen of AZD1222 (MSD serology assay) with its 95% CI will be computed at each time point in each treatment arm in each cohort (A, B, C, and D) and also in Subcohorts B1, B2, D1, and D2 separately.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AZD1222 for the Prevention of COVID-19 in Japan
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: AZD1222
    For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2
  • 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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: AZD1222
  • Placebo Comparator: 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.
    Intervention: Drug: 0.9% (w/v) saline
Publications * 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. 2021 Oct 21. pii: S1201-9712(21)00818-3. doi: 10.1016/j.ijid.2021.10.030. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2020)
256
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
12
Actual Study Completion Date  ICMJE November 22, 2021
Actual Primary Completion Date November 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04568031
Other Study ID Numbers  ICMJE D8111C00002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
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
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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Iqvia Pty Ltd
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP