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

Primary Purpose

COVID-19, Coronavirus Infections

Status
Recruiting
Phase
Phase 3
Locations
United Arab Emirates
Study Type
Interventional
Intervention
LIBP-Rec-Vaccine
BIBP-Rec-Vaccine
placebo
Sponsored by
National Vaccine and Serum Institute, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sheikh Khalifa Medical CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Cohort 1 LIBP-Rec-Vaccine Group

Cohort 1 BIBP-Rec-Vaccine Group

Cohort 1 placebo control group

Cohort 2 LIBP-Rec-Vaccine Group

Cohort 2 BIBP-Rec-Vaccine Group

Arm Description

Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months

Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months

Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months

Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months

Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Immunogenicity subgroup only
The incidence and severity of any adverse reactions
The incidence and severity of solicited adverse events
The incidence and severity of solicited adverse reactions
The incidence and severity of unsolicited adverse reactions
The incidence and severity of solicited adverse reactions
The incidence and severity of solicited adverse events
The incidence of SAE observed
The incidence of AESI observed
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

Full Information

First Posted
October 27, 2022
Last Updated
November 7, 2022
Sponsor
National Vaccine and Serum Institute, China
Collaborators
China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05599516
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Vaccine and Serum Institute, China
Collaborators
China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus Infections
Keywords
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 LIBP-Rec-Vaccine Group
Arm Type
Experimental
Arm Description
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
Arm Title
Cohort 1 BIBP-Rec-Vaccine Group
Arm Type
Experimental
Arm Description
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
Arm Title
Cohort 1 placebo control group
Arm Type
Placebo Comparator
Arm Description
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
Arm Title
Cohort 2 LIBP-Rec-Vaccine Group
Arm Type
Experimental
Arm Description
Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months
Arm Title
Cohort 2 BIBP-Rec-Vaccine Group
Arm Type
Experimental
Arm Description
Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months
Intervention Type
Biological
Intervention Name(s)
LIBP-Rec-Vaccine
Intervention Description
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Intervention Type
Biological
Intervention Name(s)
BIBP-Rec-Vaccine
Intervention Description
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Primary Outcome Measure Information:
Title
Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.
Description
Rates of cohort 1 subjects not infected with COVID-19
Time Frame
14th day after vaccination
Secondary Outcome Measure Information:
Title
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above
Description
Rates of cohort 1 subjects who are not asymptomatic infection with COVID-19
Time Frame
14th day after vaccination
Title
Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above
Description
Rates of cohort 1 subjects who are not severe cases with COVID-19
Time Frame
14th day after vaccination
Title
Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above.
Description
Rates of cohort 1 subjects who are not related deaths with COVID-19
Time Frame
14th day after vaccination
Title
GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1( LIBP-Rec-Vaccine / BIBP-Rec-Vaccine)
Description
Cohort 2 Immunogenicity subgroup only
Time Frame
14th day after vaccination
Title
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Description
Immunogenicity subgroup only
Time Frame
14th day、28th day after vaccination
Title
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Description
Immunogenicity subgroup only
Time Frame
14th day、28th day after vaccination
Title
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Description
Immunogenicity subgroup only
Time Frame
14th day、28th day after vaccination
Title
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Description
Immunogenicity subgroup only
Time Frame
3th month、6th month after vaccination
Title
GMI of subject's anti- SARS-CoV-2 neutralizing antibody
Description
Immunogenicity subgroup only
Time Frame
3th month、6th month after vaccination
Title
4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody
Description
Immunogenicity subgroup only
Time Frame
3th month、6th month after vaccination
Title
The incidence and severity of any adverse reactions
Time Frame
within 30 minutes after vaccination
Title
The incidence and severity of solicited adverse events
Time Frame
within 30 minutes after vaccination
Title
The incidence and severity of solicited adverse reactions
Time Frame
within 0-7 days after vaccination
Title
The incidence and severity of unsolicited adverse reactions
Time Frame
within 0-7 days after vaccination
Title
The incidence and severity of solicited adverse reactions
Time Frame
within 8-30 days after vaccination
Title
The incidence and severity of solicited adverse events
Time Frame
within 8-30 days after vaccination
Title
The incidence of SAE observed
Time Frame
Within 6 months of vaccination
Title
The incidence of AESI observed
Time Frame
Within 6 months of vaccination
Title
Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants)
Description
Immunogenicity subgroup only
Time Frame
14th day after vaccination
Other Pre-specified Outcome Measures:
Title
Subject's the genotypes of SARS-CoV-2 virus in endpoint cases
Time Frame
During the study, approximately 14 months
Title
Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine
Time Frame
During the study, approximately 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Sheikh Khalifa Medical City
City
Seha
State/Province
Abu Dhab
ZIP/Postal Code
519000
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunkai Yang, Prof.
Phone
+8613601126881
Email
yangyunkai@sinopharm.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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