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| Name | Class |
|---|---|
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
| Wuhan Institute of Biological Products Co., Ltd | INDUSTRY |
| The University of Hong Kong | OTHER |
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This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: BIBP Inactivated COVID-19 vaccine (Omicron) | Experimental | subjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine |
|
| 2: WIBP Inactivated COVID-19 vaccine (Omicron) | Experimental | subjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine |
|
| 3:BIBP Inactivated COVID-19 vaccine (Omicron) | Experimental | subjects will be blinded and receive two doses of BIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine |
|
| 4: WIBP Inactivated COVID-19 vaccine (Omicron) | Experimental | subjects will be blinded and receive two doses of WIBP Inactivated COVID-19 vaccine (Omicron) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine |
|
| 5:Inactivated COVID-19 Vaccine (prototype) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) | Biological | intramuscular injection in the deltoid muscle |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) of anti-omicron neutralizing antibody | 28 days after sequential vaccination of 2 doses | |
| The 4-fold rise rate of anti-omicron neutralizing antibody | 28 days after sequential vaccination of 2 doses |
| Measure | Description | Time Frame |
|---|---|---|
| The GMT of anti-omicron neutralizing antibody | 14 days after sequential vaccination of 2 doses | |
| The 4-fold rise rate of anti-omicron neutralizing antibody | 14 days after sequential vaccination of 2 doses |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19 | From 14 day after vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Hung, Clinical Professor | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
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| Active Comparator |
subjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of inactivated COVID-19 vaccine |
|
| 6:Inactivated COVID-19 Vaccine (prototype) | Active Comparator | subjects will be blinded and receive two doses of Inactivated COVID-19 Vaccine (prototype) with 28 days apart more than 3 months after 2 or 3 doses of COVID-19 mRNA vaccine |
|
| WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell) | Biological | intramuscular injection in the deltoid muscle |
|
| COVID-19 Vaccine (Vero Cell), Inactivated | Biological | intramuscular injection in the deltoid muscle |
|
| Specific cellular immune response | within 28 days after vaccination |
| The GMT of anti-omicron Immunoglobulin G (IgG) antibody | 28 days after sequential vaccination of 2 doses |
| The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | 28 days after sequential vaccination of 2 doses |
| The proportion of subjects with neutralizing antibody GMT ≥1:16,≥1:32 and ≥1:64 | on 3rd month, 6th month, 9th month, and 12th month after vaccination |
| The incidence of any adverse reactions/events | 28 days after each immunization |
| The incidence of serious adverse events (SAE) and adverse events special interest (AESI) | from 1st booster dose and up to 6 months following 2nd booster dose |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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