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Trial record 3 of 13 for:    AZD1222 | covid

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

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ClinicalTrials.gov Identifier: NCT04568031
Recruitment Status : Active, not recruiting
First Posted : September 29, 2020
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: AZD1222 Drug: 0.9% (w/v) saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : August 23, 2020
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Arm Intervention/treatment
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.
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

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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)


  6. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568031


Locations
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Japan
Research Site
Fukuoka-shi, Japan, 810-0021
Research Site
Hachioji-shi, Japan, 192-0046
Research Site
Minato-ku, Japan, 108-0075
Research Site
Sumida-ku, Japan, 130-0004
Research Site
Toshima-ku, Japan, 171-0021
Sponsors and Collaborators
AstraZeneca
Iqvia Pty Ltd
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04568031    
Other Study ID Numbers: D8111C00002
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
COVID-19 Vaccine