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

COVID-19 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599516
• Other study ID #: CNBG-REC-2022006
• Status: Recruiting
• Phase: Phase 3
• Start date: November 4, 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: National Vaccine and Serum Institute, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

Biological:
• LIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
• BIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
• placebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm

Locations

Country	Name	City	State
United Arab Emirates	Sheikh Khalifa Medical City	Seha	Abu Dhab

Sponsors (4)

Lead Sponsor	Collaborator
National Vaccine and Serum Institute, China	Beijing Institute of Biological Products Co Ltd., China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject's the genotypes of SARS-CoV-2 virus in endpoint cases		During the study, approximately 14 months
Other	Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine		During the study, approximately 14 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	GMT of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	14th day?28th day after vaccination
Secondary	GMI of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	14th day?28th day after vaccination
Secondary	4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	14th day?28th day after vaccination
Secondary	GMT of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	3th month?6th month after vaccination
Secondary	GMI of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	3th month?6th month after vaccination
Secondary	4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody	Immunogenicity subgroup only	3th month?6th month after vaccination
Secondary	The incidence and severity of any adverse reactions		within 30 minutes after vaccination
Secondary	The incidence and severity of solicited adverse events		within 30 minutes after vaccination
Secondary	The incidence and severity of solicited adverse reactions		within 0-7 days after vaccination
Secondary	The incidence and severity of unsolicited adverse reactions		within 0-7 days after vaccination
Secondary	The incidence and severity of solicited adverse reactions		within 8-30 days after vaccination
Secondary	The incidence and severity of solicited adverse events		within 8-30 days after vaccination
Secondary	The incidence of SAE observed		Within 6 months of vaccination
Secondary	The incidence of AESI observed		Within 6 months of vaccination
Secondary	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