A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)

NCT ID: NCT05293548

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2023-08-31

Brief Summary

A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

NVSI-06-09 Sequential Immunization Group

the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months

Group Type: EXPERIMENTAL

Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09)

Intervention Type: BIOLOGICAL

Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) in the deltoid muscle of the upper arm

Inactivated Vaccine Sequential Immunization Group

the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months

Group Type: ACTIVE_COMPARATOR

Inactivated COVID-19 vaccine (Vero cells)

Intervention Type: BIOLOGICAL

Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Interventions

Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09)

Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) in the deltoid muscle of the upper arm

Intervention Type: BIOLOGICAL

Inactivated COVID-19 vaccine (Vero cells)

Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age: population aged 18 years and above;
• Judged by the investigator that the health condition is well after inquiry and physical examination;
• Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
• Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
• Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;

Exclusion Criteria

• COVID-19 infection positive patients (including suspected or asymptomatic cases);
• Have a history of SARS and MERS infection;
• Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
• Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
• Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
• History of thrombocytopenia or other coagulation disorders;
• Patients with known immunological impairment or immunocompromised.
• Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment
• Have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (HIV) infection (test report available);
• Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic blood pressure 95 mmHg).
• Received live attenuated vaccines within 1 month before study enrollment;
• Received inactivated vaccines within 14 days before study enrollment;
• Received other investigational drugs within 6 months before study enrollment;
• Other vaccination-related contraindications considered by investigators.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: collaborator

Lanzhou Institute of Biological Products Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Institute of Biological Products Co Ltd.

INDUSTRY

Sponsor Role: collaborator

National Vaccine and Serum Institute, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheikh Khalifa Medical City

SEHA, Abu Dhab, United Arab Emirates

Countries

United Arab Emirates

Other Identifiers

CNBG-REC-2022002

Identifier Type: -

Identifier Source: org_study_id