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A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated (COVID-19)

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ClinicalTrials.gov Identifier: NCT04863638
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Beijing Institute of Biological Products Co Ltd.
Information provided by (Responsible Party):
China National Biotec Group Company Limited

Brief Summary:
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivatedand in population aged 60 years old and 3-17 years old with different 3-dose schedules compared to that in population aged 18-59 years old with 2-dose schedule. And subjects in the same age are randomly assigned to different immunization schedule groups.

Condition or disease Intervention/treatment Phase
Covid19 Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated Biological: 2 doses of vaccine Phase 4

Detailed Description:
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivatedand in population aged 60 years old and 3-17 years old with different 3-dose schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Immunobridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated in Population Aged ≥ 60 Years Old and 3-17 Years Old Compared With That in Population Aged 18-59 Years Old
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2024

Arm Intervention/treatment
Experimental: A1 aged ≥ 71
300 subjects age ≥ 71 (A1)receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42

Experimental: A2 aged ≥ 71
200 subjects age ≥ 71 (A2)receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111

Experimental: A3 aged ≥ 71
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171

Experimental: B1 aged 60-70
300 subjects age 60-70 (B1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42

Experimental: B2 aged 60-70
200 subjects age 60-70 (B2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111

Experimental: B3 aged 60-70
200 subjects age 60-70 (B3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171

Experimental: C1 aged 18-59
300 subjects age 18-59 (C1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42

Experimental: C2 aged 18-59
200 subjects age 18-59 (C2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111

Experimental: C3 aged 18-59
200 subjects age 18-59 (C3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171

Experimental: C4 aged 18-59
300 subjects age 18-59 (C4) receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21

Experimental: D1 aged 9-17
300 subjects age 9-17 (D1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42

Experimental: D2 aged 9-17
200 subjects age 9-17 (D2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111

Experimental: D3 aged 9-17
200 subjects age 9-17 (D3)receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171

Experimental: D4 aged 9-17
300 subjects age 9-17 (D4)receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21

Experimental: E1 aged 3-8
300 subjects age 3-8 (E1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 42

Experimental: E2 aged 3-8
200 subjects age 3-8 (E2)receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 111

Experimental: E3 aged 3-8
200 subjects age 3-8 (E3)receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
the schedule of Day 0, 21, 171

Experimental: E4 aged 3-8
300 subjects age 3-8 (E4)receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21




Primary Outcome Measures :
  1. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after the full course immunization ]
    Neutralizing antibody assay will be performed using the Microcytopathic assay

  2. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after the full course immunization ]
    ≥4 fold increase from baseline


Secondary Outcome Measures :
  1. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after the second dose in schedule of Day 0,21,42 ]
    Neutralizing antibody assay will be performed using the Microcytopathic assay

  2. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after the second dose in schedule of Day 0,21,42 ]
    ≥4 fold increase from baseline

  3. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171 ]
    Neutralizing antibody assay will be performed using the Microcytopathic assay

  4. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171 ]
    ≥4 fold increase from baseline

  5. Immune Persistence [ Time Frame: 3 months, 6 months, 12 months after the full course immunization ]
    Neutralizing antibody assay will be performed using the Microcytopathic assay

  6. Safety index-Incidence of adverse reactions [ Time Frame: From the beginning of the vaccination to 28 days after the full course immunization ]
    collect the all the adverse events using dairy card and contact card

  7. Safety index-Incidence of serious adverse events [ Time Frame: From the beginning of the vaccination to 6 months after the full course immunization ]
    All SAEs will be collected


Other Outcome Measures:
  1. Immune Persistence [ Time Frame: 18 months and 24 months after the full immunization ]
    Neutralizing antibody assay will be performed using the Microcytopathic assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 3 years and above (after enrolled, subjects will be allocated according to age).
  • By asking for medical history and physical examination, the health condition judged by the investigators is well.
  • Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
  • No vaccination history of COVID-19 vaccine before enrollment.
  • Be able and willing to complete the whole prescribed study plan.
  • With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

Exclusion Criteria:

  • Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
  • Has a history of SARS, MERS infection (self-report, on-site inquiry).
  • >14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
  • Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
  • With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
  • Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
  • Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  • With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
  • Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
  • Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  • Received blood products within 3 months before enrolment.
  • Received other research drugs within 6 months before enrolment.
  • Other circumstances judged by investigators are not suitable for this clinical trial.

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): NCT04863638


Contacts
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Contact: Yunkai Yang, Prof. +8613601126881 yangyunkai@sinopharm.com

Locations
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China, Henan
Yanjin County Center for Disease Control and Prevention Recruiting
Xinxiang, Henan, China, 453200
Contact: Guangjie Zhu    +8618637367986    zgj-jk2009@163.com   
Sponsors and Collaborators
China National Biotec Group Company Limited
Beijing Institute of Biological Products Co Ltd.
Investigators
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Principal Investigator: Yanxia Wang, Bachelor Henan Provincial Center for Disease Control and Prevention
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Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT04863638    
Other Study ID Numbers: BIBP2020004CN
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: April 2021

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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 China National Biotec Group Company Limited:
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs