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

NCT05293548 | Unknown Phase 2

• 1 other identifier: CNBG-REC-2022002
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19

Outcome Measures

Primary Outcomes (10)

• GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age

  14 days after sequential immunization of one booster dose

• the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age

  14 days after a single dose of the booster vaccine

• The incidence rate of any adverse reactions/events

  within 30 minutes after vaccination

• The incidence severity of any adverse reactions/events

  within 30 minutes after vaccination

• The incidence rate of solicited adverse reactions/events

  within 0-7 days after vaccination

• The incidence severity of solicited adverse reactions/events

  within 0-7 days after vaccination

• The incidence rate of solicited adverse reactions/events

  within 8-30 days after vaccination

• The incidence severity of solicited adverse reactions/events

  within 8-30 days after immunization

• The incidence of SAE observed

  up to 12 months after full course of immunization

• The incidence of AESI observed

  up to 12 months after full course of immunization

Secondary Outcomes (10)

• 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age

  28 days after sequential immunization of one booster dose

• GMT of anti-omicron neutralizing antibody in adults ≥18 years of age

  28 days after sequential immunization of one booster dose

• 4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age

  28 days after sequential immunization of one booster dose

• GMT of anti-omicron IgG antibody in adults ≥18 years of age

  before booster vaccination and 28 days after a single dose of the booster vaccine

• 4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age

  before booster vaccination and 28 days after a single dose of the booster vaccine

Other Outcomes (3)

• The efficacy of recombinant COVID-19 vaccine (CHO cell, NVSI-06-09) against COVID-19, severe cases and deaths after 14 days following sequential immunization in adults ≥18 years of age

  During the study，an average of one and a half years

• Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age

  14 days after a single dose of the booster vaccine

• Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age

  28 days after a single dose of the booster vaccine

Study Arms (2)

NVSI-06-09 Sequential Immunization Group

EXPERIMENTAL

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

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

Inactivated Vaccine Sequential Immunization Group

ACTIVE COMPARATOR

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

Biological: Inactivated COVID-19 vaccine (Vero cells)

Interventions

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

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

NVSI-06-09 Sequential Immunization Group

Inactivated COVID-19 vaccine (Vero cells) 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

Inactivated Vaccine Sequential Immunization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Vaccine and Serum Institute, China: lead
• China National Biotec Group Company Limited: collaborator
• Lanzhou Institute of Biological Products Co., Ltd: collaborator
• Beijing Institute of Biological Products Co Ltd.: collaborator

Study Sites (1)

Sheikh Khalifa Medical City

SEHA, Abu Dhab, 519000, United Arab Emirates

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 24, 2022
• Study Start: May 25, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)