Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above

This clinical trial adopts a randomized, double-blind and placebo-controlled design.

A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.

Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infections; COVID-19
• Intervention / Treatment: Biological: LIBP-Rec-Vaccine; Biological: BIBP-Rec-Vaccine; Biological: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 16000
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhab
    • Seha, Abu Dhab, United Arab Emirates, 519000
      • Recruiting
      • Sheikh Khalifa Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age range: healthy population aged ≥18;
• Judged by the investigator that the health condition is well after inquiry and physical examination;
• Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
• Be able and willing to complete all prescribed study schedules during the whole study period;
• The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.

Exclusion Criteria:

• Symptomatic and suspected COVID 19 infection positive ;
• Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
• Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
• Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
• Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
• With known immunological impairment or compromised immunological function diagnosed by the hospital;
• Received whole blood, plasma and immunoglobulin therapy within 1 month;
• Known or suspected of suffering from the following diseases: acute or chronic active respiratory diseases, severe cardiovascular diseases [cardiopulmonary failure, hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg)], acute infection, active phase of chronic disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be provided)
• Received live attenuated vaccine within one month before vaccination;
• Received inactivated vaccine within 14 days before vaccination;
• Other contraindications related to vaccination that investigators believe.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 LIBP-Rec-Vaccine Group; Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months	Biological: LIBP-Rec-Vaccine; Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Experimental: Cohort 1 BIBP-Rec-Vaccine Group; Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months	Biological: BIBP-Rec-Vaccine; Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Placebo Comparator: Cohort 1 placebo control group; Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months	Biological: placebo; Intramuscular injection of placebo in the deltoid muscle of the upper arm
Experimental: Cohort 2 LIBP-Rec-Vaccine Group; Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months	Biological: LIBP-Rec-Vaccine; Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Experimental: Cohort 2 BIBP-Rec-Vaccine Group; Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months	Biological: BIBP-Rec-Vaccine; Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.	Rates of cohort 1 subjects not infected with COVID-19	14th day after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above	Rates of cohort 1 subjects who are not asymptomatic infection with COVID-19	14th day after vaccination
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above	Rates of cohort 1 subjects who are not severe cases with COVID-19	14th day after vaccination
Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above.	Rates of cohort 1 subjects who are not related deaths with COVID-19	14th day after vaccination
GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine）	Cohort 2 Immunogenicity subgroup only	14th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	14th day、28th day after vaccination
GMI of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	14th day、28th day after vaccination
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	14th day、28th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	3th month、6th month after vaccination
GMI of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	3th month、6th month after vaccination
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	3th month、6th month after vaccination
The incidence and severity of any adverse reactions		within 30 minutes after vaccination
The incidence and severity of solicited adverse events		within 30 minutes after vaccination
The incidence and severity of solicited adverse reactions		within 0-7 days after vaccination
The incidence and severity of unsolicited adverse reactions		within 0-7 days after vaccination
The incidence and severity of solicited adverse reactions		within 8-30 days after vaccination
The incidence and severity of solicited adverse events		within 8-30 days after vaccination
The incidence of SAE observed		Within 6 months of vaccination
The incidence of AESI observed		Within 6 months of vaccination
Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants)	Immunogenicity subgroup only	14th day after vaccination

Other Outcome Measures

Outcome Measure	Time Frame
Subject's the genotypes of SARS-CoV-2 virus in endpoint cases	During the study, approximately 14 months
Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine	During the study, approximately 14 months

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): November 4, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CNBG-REC-2022006

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