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This is a randomized, open-label, parallel-controlled study to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) after priming with an inactivated SARS-CoV-2 vaccine in adults at 18 years of age or above. 420 healthy subjects aged over or equal to 18 years whom have received two doses of inactivated SARS-CoV-2 vaccines within the last 3~9 months, will be recruited in this study. Eligible participants will be randomized at a 1:1:1 ratio to receive a booster dose of inactive SARS-CoV-2 vaccine or a low dose of aerosolized Ad5-nCoV or a high dose of aerosolized Ad5-nCoV. 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 the day 0 before and day 7, 14, 28 and month 3, 6, and 12 after the booster vaccination. Each subject will remain in this study for approximately 13 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated vaccine group | Active Comparator | Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of inactivated SARS-CoV-2 vaccine |
|
| Low dose aerosolized Ad5-nCoV group | Experimental | Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of the low dose of aerosolized Ad5-nCoV. |
|
| High dose aerosolized Ad5-nCoV group | Experimental | Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of the high dose of aerosolized Ad5-nCoV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions within 14 days after the booster dose. | Incidence of adverse reactions within 14 days after vaccination. | Within 14 days 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 adverse events within 0-28 days after the booster dose. | Incidence of adverse events (AE) within 0-28 days after the booster vaccination. | within 28 days after the booster dose. |
| Incidence of serious adverse events (SAE) till the 12 months after the booster dose. |
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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 |
|---|---|---|---|---|---|---|
| Donghai County Center for Diseases Control and Prevention | Lianyungang | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36503413 | Derived | Jin L, Tang R, Wu S, Guo X, Huang H, Hou L, Chen X, Zhu T, Gou J, Zhong J, Pan H, Cui L, Chen Y, Xia X, Feng J, Wang X, Zhao Q, Xu X, Li Z, Zhang X, Chen W, Li J, Zhu F. Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial. Emerg Microbes Infect. 2023 Dec;12(1):2155251. doi: 10.1080/22221751.2022.2155251. | |
| 35605625 |
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| Low dose aerosolized Ad5-nCoV | Biological | This vaccine is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.1 ml / dose, contains 1×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation. |
|
| High dose aerosolized Ad5-nCoV | Biological | This vaccine is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.2 ml / dose, contains 2×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation. |
|
Incidence of serious adverse events (SAE) till the 12 months after booster vaccination. |
| within 12 months after the booster dose. |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose. | GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose. | on day 7 and 28 after the boost vaccination. |
| Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster vaccination. | Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14 after the booster vaccination. | on day 14 after the last dose of vaccination. |
| GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose. | GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose. | at month 3, 6, and 12 after the boost vaccination. |
| GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD on day 7, day 14, day 28 after the booster dose. | GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 7, day 14, day 28 after the booster vaccination. | on day 7, day 14, day 28 after the booster vaccination. |
| GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD at month 3, 6, and 12 after the booster dose. | GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA at month 3, 6, and 12 after the booster vaccination. | at month 3, 6, and 12 after the booster vaccination. |
| The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination. | The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination. | on day 7 and 14 after the booster vaccination. |
| Derived |
| Li JX, Wu SP, Guo XL, Tang R, Huang BY, Chen XQ, Chen Y, Hou LH, Liu JX, Zhong J, Pan HX, Shi FJ, Xu XY, Li ZP, Zhang XY, Cui LB, Tan WJ, Chen W, Zhu FC; CanSino COVID-19 Study Group. Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial. Lancet Respir Med. 2022 Aug;10(8):739-748. doi: 10.1016/S2213-2600(22)00087-X. Epub 2022 May 20. |
| 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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