Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
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. [14th day after vaccination]
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 [14th day after vaccination]
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 [14th day after vaccination]
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. [14th day after vaccination]
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） [14th day after vaccination]
Cohort 2 Immunogenicity subgroup only
- GMT of subject's anti- SARS-CoV-2 neutralizing antibody [14th day、28th day after vaccination]
Immunogenicity subgroup only
- GMI of subject's anti- SARS-CoV-2 neutralizing antibody [14th day、28th day after vaccination]
Immunogenicity subgroup only
- 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody [14th day、28th day after vaccination]
Immunogenicity subgroup only
- GMT of subject's anti- SARS-CoV-2 neutralizing antibody [3th month、6th month after vaccination]
Immunogenicity subgroup only
- GMI of subject's anti- SARS-CoV-2 neutralizing antibody [3th month、6th month after vaccination]
Immunogenicity subgroup only
- 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody [3th month、6th month after vaccination]
Immunogenicity subgroup only
- The incidence and severity of any adverse reactions [within 30 minutes after vaccination]
- The incidence and severity of solicited adverse events [within 30 minutes after vaccination]
- The incidence and severity of solicited adverse reactions [within 0-7 days after vaccination]
- The incidence and severity of unsolicited adverse reactions [within 0-7 days after vaccination]
- The incidence and severity of solicited adverse reactions [within 8-30 days after vaccination]
- The incidence and severity of solicited adverse events [within 8-30 days after vaccination]
- The incidence of SAE observed [Within 6 months of vaccination]
- The incidence of AESI observed [Within 6 months of vaccination]
- Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants) [14th day after vaccination]
Immunogenicity subgroup only
Other Outcome Measures
- Subject's the genotypes of SARS-CoV-2 virus in endpoint cases [During the study, approximately 14 months]
- Explore the occurrence of ADE/VED following immunization with LIBP-Rec-Vaccine and BIBP-Rec-Vaccine [During the study, approximately 14 months]
Eligibility Criteria
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;
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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;
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheikh Khalifa Medical City | Seha | Abu Dhab | United Arab Emirates | 519000 |
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.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNBG-REC-2022006