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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
| Lanzhou Institute of Biological Products Co., Ltd | INDUSTRY |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 LIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months |
|
| Cohort 1 BIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months |
|
| Cohort 1 placebo control group | Placebo Comparator | Subject vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months |
|
| Cohort 2 LIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months |
|
| Cohort 2 BIBP-Rec-Vaccine Group | Experimental | Subject vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIBP-Rec-Vaccine | Biological | Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14th day after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14th day after vaccination |
| Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Khalifa Medical City | Recruiting | SEHA | Abu Dhab | 519000 | United Arab Emirates |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| BIBP-Rec-Vaccine | Biological | Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm |
|
| placebo | Biological | Intramuscular injection of placebo in the deltoid muscle of the upper arm |
|
Rates of cohort 1 subjects who are not severe cases with COVID-19 |
| 14th day after vaccination |
| 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 | 14th day after vaccination |
| 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 | 14th day after vaccination |
| GMT of subject's anti- SARS-CoV-2 neutralizing antibody | Immunogenicity subgroup only | 14th day、28th day after vaccination |
| GMI of subject's anti- SARS-CoV-2 neutralizing antibody | Immunogenicity subgroup only | 14th day、28th day after vaccination |
| 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody | Immunogenicity subgroup only | 14th day、28th day after vaccination |
| GMT of subject's anti- SARS-CoV-2 neutralizing antibody | Immunogenicity subgroup only | 3th month、6th month after vaccination |
| GMI of subject's anti- SARS-CoV-2 neutralizing antibody | Immunogenicity subgroup only | 3th month、6th month after vaccination |
| 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody | Immunogenicity subgroup only | 3th month、6th month after vaccination |
| 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) | Immunogenicity subgroup only | 14th day after vaccination |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |