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

• ClinicalTrials.gov Identifier: NCT04863638
• Recruitment Status: Recruiting
• First Posted: April 28, 2021
• Last Update Posted: June 21, 2022
• Sponsor: China National Biotec Group Company Limited
• Collaborator: Beijing Institute of Biological Products Co Ltd.
• Information provided by (Responsible Party): China National Biotec Group Company Limited

Study Description

Brief Summary:

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different 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), Inactivated and in population aged 60 years old and 3-17 years old with different 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.

Study Design

• 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
• Actual Primary Completion Date: December 20, 2021
• Estimated Study Completion Date: March 31, 2024

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Yanxia Wang, Bachelor; Henan Provincial Center for Disease Control and Prevention

More Information

• Responsible Party: China National Biotec Group Company Limited
• ClinicalTrials.gov Identifier: NCT04863638
• Other Study ID Numbers: BIBP2020004CN
• First Posted: April 28, 2021
• Last Update Posted: June 21, 2022
• Last Verified: May 2022

• 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:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs