Coronavirus Infections, COVID-19
Conditions
Keywords
COVID-19
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.
Interventions
BIOLOGICALLIBP-Rec-Vaccine
Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
BIOLOGICALBIBP-Rec-Vaccine
Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
BIOLOGICALplacebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Sponsors
China National Biotec Group Company Limited
Lanzhou Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co Ltd.
National Vaccine and Serum Institute, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 of SAE observed | Within 6 months of vaccination | — |
Other
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Arab Emirates
Outcome results
None listed