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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 is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 4-6 months, 7-9 months and >9 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject last vaccination time is within 4-6 months(sequential clinical trial group) | Experimental | Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 4-6 months |
|
| Subject last vaccination time is within 7-9 months(sequential clinical trial group) | Experimental | Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days 7-9 months |
|
| Subject last vaccination time more than 9 months(sequential clinical trial group) | Experimental | Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 9 months |
|
| Safety Observation Group | Experimental | Subject have been vaccinated with three doses of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) on 0,30,60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) | Biological | Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and serverity of any adverse reactions | within 30 minutes after vaccination | |
| The incidence and serverity of solicited adverse events | within 30 minutes after vaccination | |
| The incidence and serverity 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 serverity of solicited adverse reactions | within 8-30 days after vaccination | |
| The incidence and serverity of solicited adverse events | within 8-30 days after vaccination | |
| The incidence of SAE observed | after vaccination and up to 6 months after full course of immunization. | |
| The incidence of AESI observed | after vaccination and up to 6 months after full course of immunization | |
| GMT of subject's anti- SARS-CoV-2 neutralizing antibody | 15th day after vaccination | |
| GMT of subject's anti- SARS-CoV-2 neutralizing antibody | 30th day after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody | before vaccination | |
| Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody | 30th day after the full course of vaccination | |
| Measure | Description | Time Frame |
|---|---|---|
| The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths | 14th day after vaccination | |
| Anti-SARS-CoV-2 neutralizing antibody | 3th month, 6th month, 9th month and 12th month after full course of immunization |
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35760812 | Derived | Kaabi NA, Yang YK, Du LF, Xu K, Shao S, Liang Y, Kang Y, Su JG, Zhang J, Yang T, Hussein S, ElDein MS, Yang SS, Lei W, Gao XJ, Jiang Z, Cong X, Tan Y, Wang H, Li M, Mekki HM, Zaher W, Mahmoud S, Zhang X, Qu C, Liu DY, Zhang J, Yang M, Eltantawy I, Hou JW, Lei ZH, Xiao P, Wang ZN, Yin JL, Mao XY, Zhang J, Qu L, Zhang YT, Yang XM, Wu G, Li QM. Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial. Nat Commun. 2022 Jun 27;13(1):3654. doi: 10.1038/s41467-022-31379-0. |
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| Inactivated COVID-19 vaccine (Vero cells) | Biological | Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm |
|
| 3 doses Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) | Biological | Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm on 0,30,60 days |
|
| Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody | 15th day after vaccination |
| Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody | 30th day after vaccination |
| Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody |
| before vaccination |
| Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody | 30th day after the full course of vaccination |
| GMI of subject's anti-SARS-CoV-2 IgG antibody | before vaccination |
| GMI of subject's anti-SARS-CoV-2 IgG antibody | 30th day after the full course of vaccination |
| Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | before vaccination |
| Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | 30th day after the full course of vaccination |
| Rate of Anti-SAR-CoR-2 neutralizing antibody | only sequential clinical trial group | the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination |
| Rate of GMT of IgG antibody | only sequential clinical trial group | the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination |
| Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | only sequential clinical trial group | the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination |
| Rate of Anti-SAR-CoR-2 neutralizing antibody | only Safety Observation Group | the 6th month, 12th month after the full course of vaccination |
| Rate of GMT of IgG antibody | only Safety Observation Group | the 6th month, 12th month after the full course of vaccination |
| Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | only Safety Observation Group | the 6th month, 12th month after the full course of vaccination |
| Anti-SARS-CoV-2 GMT of IgG antibody | 3th month, 6th month, 9th month and 12th month after full course of immunization |
| Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | 3th month, 6th month, 9th month and 12th month after full course of immunization |
| The vaccine efficacy of recombinant COVID-19 vaccine (CHO cells,NVSI-06-08) against COVID-19, severe cases and deaths aged 18 years and above | 15th day after full course of immunization |
| To evaluate the vaccine efficacy of recombinant COVID-19 vaccine (CHO cells,NVSI-06-08) against different variants after sequential vaccination at different schedules | only sequential clinical trial group | 15th day after full course of immunization |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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