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| Name | Class |
|---|---|
| CanSino Biologics Inc. | INDUSTRY |
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This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant SARS-CoV-2 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 18-59 years after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 18-59 years will be recruited in this study. Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other 100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on day 0 before the boosting with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody levels, cellular immune responses and the subgroups or germlines of the specific B cells will be analyzed. Each subject will remain in this study for approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| heterologous boost arm with Ad5 vectored vaccine | Experimental | Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months. |
|
| homogeneous boost arm with inactive vaccine | Active Comparator | Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3~6 months. |
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| heterologous regimen with Ad5 vectored vaccine | Experimental | Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months. |
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| homogeneous regimen arm with inactive vaccine | Active Comparator | Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1~3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant SARS-CoV-2 Ad5 vectored vaccine | Biological | This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions within 28 days after the booster dose. | Incidence of adverse reactions within 28 days after vaccination. | Within 28 days after the booster dose |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose. | GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination. | On day 14 after the booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited AE within 14 days after the booster dose | Incidence of solicited adverse events (AE) within 14 days after the booster vaccination. | within 14 days after the booster dose |
| Incidence of unsolicited AE within 28 days after the booster dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination. | Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination. | on day 14, day 28 and month 6 after the booster vaccination |
| GMT of neutralizing antibodies against P.1 virants on day 28 after the booster vaccination. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing-Xin Li, PhD | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35087233 | Derived | Li J, Hou L, Guo X, Jin P, Wu S, Zhu J, Pan H, Wang X, Song Z, Wan J, Cui L, Li J, Chen Y, Wang X, Jin L, Liu J, Shi F, Xu X, Zhu T, Chen W, Zhu F. Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial. Nat Med. 2022 Feb;28(2):401-409. doi: 10.1038/s41591-021-01677-z. Epub 2022 Jan 27. |
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Subjects who have been primed with one dose or two doses of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine
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Unblinded staff will responsible for the vaccine administration and management, and other investigators will be kept blinded.
|
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| Inactive SARS-CoV-2 vaccine (Vero cell) | Biological | This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle. |
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Incidence of unsolicited adverse events (AE) within 28 days after vaccination. |
| within 28 days after the booster dose |
| Incidence of serious adverse events (SAE) till the 6 months after the booster dose. | Incidence of serious adverse events (SAE) till the 6 months after booster vaccination. | within 6 months after the booster dose |
| GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose. | GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6 after the booster vaccination. | on day 14, day 28 and month 6 after the booster vaccination |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose. | GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose. | on day 28 and month 6 after the last dose of vaccination |
| Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination. | Fold increase of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination. | on day 14, day 28 and month 6 after the booster vaccination |
| Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination. | Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination. | on day 14, day 28 and month 6 after the last dose of vaccination |
| Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination. | Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination. | on day 14, day 28 and month 6 after the booster vaccination |
| Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination. | Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination. | on day 14, day 28 and month 6 after the booster vaccination |
| Specific T cell responses on day 14 after the booster vaccination. | Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT. | on day 14 after the booster vaccination |
GMT of neutralizing antibodies against P.1 virants on day 28 after the booster vaccination. |
| on day 28 after the booster vaccination |
| GMT of neutralizing antibodies against 501Y.V2 virants on day 28 after the booster vaccination. | GMT of neutralizing antibodies against 501Y.V2 virants on day 28 after the booster vaccination. | on day 28 after the booster vaccination |
| 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 |
|---|---|
| C000706167 | Ad5-nCoV vaccine |
| C000722216 | sinovac COVID-19 vaccine |
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