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

National Vaccine and Serum Institute, China16,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

16,000

Conditions

COVID-19 Coronavirus Infections

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 14th day after vaccination

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 14th day after vaccination

GMT of subject's anti- SARS-CoV-2 neutralizing antibody

Immunogenicity subgroup only

Time frame: 14th day、28th day after vaccination

GMI of subject's anti- SARS-CoV-2 neutralizing antibody

Immunogenicity subgroup only

Time frame: 14th day、28th day after vaccination

4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody

Immunogenicity subgroup only

Time frame: 14th day、28th day after vaccination

GMT of subject's anti- SARS-CoV-2 neutralizing antibody

Immunogenicity subgroup only

Time frame: 3th month、6th month after vaccination

GMI of subject's anti- SARS-CoV-2 neutralizing antibody

Immunogenicity subgroup only

Time frame: 3th month、6th month after vaccination

4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody

Immunogenicity subgroup only

Time frame: 3th month、6th month after vaccination

The incidence and severity of any adverse reactions

Time frame: within 30 minutes after vaccination

The incidence and severity of solicited adverse events

Time frame: within 30 minutes after vaccination

The incidence and severity of solicited adverse reactions

Time frame: within 0-7 days after vaccination

The incidence and severity of unsolicited adverse reactions

Time frame: within 0-7 days after vaccination

The incidence and severity of solicited adverse reactions

Time frame: within 8-30 days after vaccination

The incidence and severity of solicited adverse events

Time frame: within 8-30 days after vaccination

The incidence of SAE observed

Time frame: Within 6 months of vaccination

The incidence of AESI observed

Time frame: 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

Time frame: 14th day after vaccination

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes