Clinical trial NCT05599516: Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Coronavirus Infections
Keywords: COVID-19
Lead sponsor: National Vaccine and Serum Institute, China
Sponsor class: INDUSTRY
Collaborators: name: China National Biotec Group Company Limited
name: Lanzhou Institute of Biological Products Co., Ltd
name: Beijing Institute of Biological Products Co Ltd.
First posted: 2022-10-31
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.
timeFrame: 14th day after vaccination
Secondary outcomes:
measure: Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above
timeFrame: 14th day after vaccination
measure: Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above
timeFrame: 14th day after vaccination
measure: Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above.
timeFrame: 14th day after vaccination
measure: GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine）
timeFrame: 14th day after vaccination
measure: GMT of subject's anti- SARS-CoV-2 neutralizing antibody
timeFrame: 14th day、28th day after vaccination
measure: GMI of subject's anti- SARS-CoV-2 neutralizing antibody
timeFrame: 14th day、28th day after vaccination
measure: 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
timeFrame: 14th day、28th day after vaccination
measure: GMT of subject's anti- SARS-CoV-2 neutralizing antibody
timeFrame: 3th month、6th month after vaccination
measure: GMI of subject's anti- SARS-CoV-2 neutralizing antibody
timeFrame: 3th month、6th month after vaccination
measure: 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
timeFrame: 3th month、6th month after vaccination
measure: The incidence and severity of any adverse reactions
timeFrame: within 30 minutes after vaccination
measure: The incidence and severity of solicited adverse events
timeFrame: within 30 minutes after vaccination
measure: The incidence and severity of solicited adverse reactions
timeFrame: within 0-7 days after vaccination
measure: The incidence and severity of unsolicited adverse reactions
timeFrame: within 0-7 days after vaccination
measure: The incidence and severity of solicited adverse reactions
timeFrame: within 8-30 days after vaccination
measure: The incidence and severity of solicited adverse events
timeFrame: within 8-30 days after vaccination
measure: The incidence of SAE observed
timeFrame: Within 6 months of vaccination
measure: The incidence of AESI observed
timeFrame: Within 6 months of vaccination
measure: Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants)
timeFrame: 14th day after vaccination
Other outcomes:
measure: Subject's the genotypes of SARS-CoV-2 virus in endpoint cases
timeFrame: During the study, approximately 14 months
measure: Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine
timeFrame: During the study, approximately 14 months
Locations:
city: Seha
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
state: Abu Dhab
Study officials:
References: