Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
NCT ID: NCT05599516
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
16000 participants
INTERVENTIONAL
2022-11-04
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Cohort 1 LIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
LIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Cohort 1 BIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
BIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Cohort 1 placebo control group
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
placebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Cohort 2 LIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months
LIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Cohort 2 BIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months
BIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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China National Biotec Group Company Limited
INDUSTRY
Lanzhou Institute of Biological Products Co., Ltd
INDUSTRY
Beijing Institute of Biological Products Co Ltd.
INDUSTRY
National Vaccine and Serum Institute, China
INDUSTRY
Responsible Party
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Locations
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Sheikh Khalifa Medical City
SEHA, Abu Dhab, United Arab Emirates
Countries
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Facility Contacts
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Other Identifiers
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CNBG-REC-2022006
Identifier Type: -
Identifier Source: org_study_id
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