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

A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09); Biological: Inactivated COVID-19 vaccine (Vero cells)

• Study Type: Interventional
• Enrollment (Anticipated): 516
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhab
    • Seha, Abu Dhab, United Arab Emirates, 519000
      • Recruiting
      • Sheikh Khalifa Medical City
      • Contact: Yunkai Yang, Prof.; Phone Number: （+86）13601126881; Email: yangyunkai@sinopharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age	before booster vaccination and 28 days after a single dose of the booster vaccine
GMI 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
GMTs of anti-omicron neutralizing antibody	3 months, 6 months, 9 months and 12 months after sequential immunization
IgG antibody of anti-omicron neutralizing antibody	3 months, 6 months, 9 months and 12 months after sequential immunization
the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64	3 months, 6 months, 9 months and 12 months after sequential immunization

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CNBG-REC-2022002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No