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| Name | Class |
|---|---|
| Anhui Provincial Center for Disease Control and Prevention | OTHER_GOV |
| Shandong Province Centers for Disease Control and Prevention | OTHER |
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
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This is a multicenter, open-label, partially radomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV-IH) after two-dose priming with an inactivated SARS-CoV-2 vaccine (ICV) in adults aged 18 years and above. 10420 healthy subjects aged over or equal to 18 years whom have received two doses of ICV before 6 months or more, will be recruited from six provinces in China in this study.Of them, 10000 eligible participants in an open cohort will receive a booster dose of Ad5-nCoV-IH to evaluate the safety profile. Another 420 participants were involved in immunogenicity cohort and randomized in a ratio of 1:1 to receive a boost of Ad5-nCoV-IH or ICV. The ICV homologous to the priming series will be supplied as the booster. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants in immunogenicity cohort on the day 0 before and 14, 28 and month 3 and 6 after the booster vaccination. Each subject will remain in this study for approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects in safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV |
|
| Group B | Experimental | Subjects in immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV |
|
| Group C | Experimental | Subjects in immunogenicity cohort will receive one homologous booster dose of ICV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosolized Ad5-nCoV | Biological | Aerosolized Ad5-nCoV 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions within 28 days after the booster dose. | Incidence of adverse reactions within 28 days after the booster dose. | Within 28 days the booster dose |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort. | GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort. | On day 28 after the booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions within 30 minutes after the booster dose. | Incidence of adverse reactions within 30 minutes after the booster dose. | Within 30 minutes after the booster dose |
| Incidence of adverse reactions within 14 days after the booster dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, Prof | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37352880 | Derived | Li JX, Hou LH, Gou JB, Yin ZD, Wu SP, Wang FZ, Zhang Z, Peng ZH, Zhu T, Shen HB, Chen W, Zhu FC; Six-Province COVID-19 Vaccine Study Group. Safety, immunogenicity and protection of heterologous boost with an aerosolised Ad5-nCoV after two-dose inactivated COVID-19 vaccines in adults: a multicentre, open-label phase 3 trial. Lancet Infect Dis. 2023 Oct;23(10):1143-1152. doi: 10.1016/S1473-3099(23)00350-X. Epub 2023 Jun 20. |
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| Yunnan Center for Disease Control and Prevention | OTHER |
| Chongqing Center for Disease Control and Prevention | OTHER |
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|
| Inactivated SARS-CoV-2 vaccine | Biological | Inactivated SARS-CoV-2 vaccine is homologous to the priming series which have been administered to the subjects, produced by SinoVac Biotech Co,. Ltd, Beijing Institute of Biological Products Co,. Ltd, Wuhan Institute of Biological Products Co,. Ltd, or Biokangtai. |
|
Incidence of adverse reactions within 14 days after the booster dose. |
| Within 14 days after the booster dose |
| Incidence of adverse events within 28 days after the booster dose. | Incidence of adverse events within 28 days after the booster dose. | 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 |
| Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose. | Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort. | On day 28 after the boost vaccination |
| GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose. | GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus as compared to baseline on day 14, month 3 and 6 after the booster dose. | On day 14, month 3 and 6 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. | 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. |
| Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose. | Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose. | On day 14, day 28 and month 3 and 6 after the booster dose |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline. | GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline. | On day 28 after the booster dose |
| GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose. | GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose. | On day 28 after the booster dose |
| The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination. | The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination. | On day 14 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 |
|---|---|
| C000706269 | SARS-CoV-2 inactivated vaccines |
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