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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05599516
Recruitment Status : Recruiting
First Posted : October 31, 2022
Last Update Posted : November 10, 2022
Sponsor:
Collaborators:
China National Biotec Group Company Limited
Lanzhou Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co Ltd.
Information provided by (Responsible Party):
National Vaccine and Serum Institute, China

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Infections Biological: LIBP-Rec-Vaccine Biological: BIBP-Rec-Vaccine Biological: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : November 4, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 LIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
 Biological: LIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Experimental: Cohort 1 BIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
 Biological: BIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Placebo Comparator: Cohort 1 placebo control group
Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months
 Biological: placebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Experimental: Cohort 2 LIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months
 Biological: LIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
Experimental: Cohort 2 BIBP-Rec-Vaccine Group
Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months
 Biological: BIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above. [ Time Frame: 14th day after vaccination ]
    Rates of cohort 1 subjects not infected with COVID-19


Secondary Outcome Measures :
  1. Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above [ Time Frame: 14th day after vaccination ]
    Rates of cohort 1 subjects who are not asymptomatic infection with COVID-19

  2. Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above [ Time Frame: 14th day after vaccination ]
    Rates of cohort 1 subjects who are not severe cases with COVID-19

  3. Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above. [ Time Frame: 14th day after vaccination ]
    Rates of cohort 1 subjects who are not related deaths with COVID-19

  4. GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine） [ Time Frame: 14th day after vaccination ]
    Cohort 2 Immunogenicity subgroup only

  5. GMT of subject's anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 14th day、28th day after vaccination ]
    Immunogenicity subgroup only

  6. GMI of subject's anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 14th day、28th day after vaccination ]
    Immunogenicity subgroup only

  7. 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 14th day、28th day after vaccination ]
    Immunogenicity subgroup only

  8. GMT of subject's anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 3th month、6th month after vaccination ]
    Immunogenicity subgroup only

  9. GMI of subject's anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 3th month、6th month after vaccination ]
    Immunogenicity subgroup only

  10. 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 3th month、6th month after vaccination ]
    Immunogenicity subgroup only

  11. The incidence and severity of any adverse reactions [ Time Frame: within 30 minutes after vaccination ]
  12. The incidence and severity of solicited adverse events [ Time Frame: within 30 minutes after vaccination ]
  13. The incidence and severity of solicited adverse reactions [ Time Frame: within 0-7 days after vaccination ]
  14. The incidence and severity of unsolicited adverse reactions [ Time Frame: within 0-7 days after vaccination ]
  15. The incidence and severity of solicited adverse reactions [ Time Frame: within 8-30 days after vaccination ]
  16. The incidence and severity of solicited adverse events [ Time Frame: within 8-30 days after vaccination ]
  17. The incidence of SAE observed [ Time Frame: Within 6 months of vaccination ]
  18. The incidence of AESI observed [ Time Frame: Within 6 months of vaccination ]
  19. Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants) [ Time Frame: 14th day after vaccination ]
    Immunogenicity subgroup only


Other Outcome Measures:
  1. Subject's the genotypes of SARS-CoV-2 virus in endpoint cases [ Time Frame: During the study, approximately 14 months ]
  2. Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine [ Time Frame: During the study, approximately 14 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05599516


Locations
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United Arab Emirates
Sheikh Khalifa Medical City Recruiting
Seha, Abu Dhab, United Arab Emirates, 519000
Contact: Yunkai Yang, Prof.    +8613601126881    yangyunkai@sinopharm.com   
Sponsors and Collaborators
National Vaccine and Serum Institute, China
China National Biotec Group Company Limited
Lanzhou Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co Ltd.
More Information
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Responsible Party: National Vaccine and Serum Institute, China
ClinicalTrials.gov Identifier: NCT05599516    
Other Study ID Numbers: CNBG-REC-2022006
First Posted: October 31, 2022    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Vaccine and Serum Institute, China:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs