Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This is a single-center, open-label phase I clinical trial of booster vaccination in healthy 18 to 60 years of age, inclusive, who has been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of booted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenovirus Type-5 Vectored COVID-19 Vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenovirus Type-5 Vectored COVID-19 Vaccine | Biological | Low dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse reactions within 14 days after booster vaccination | Occurrence of adverse reactions within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 0-14 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events within 14 days after booster vaccination | Occurrence of adverse events within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 0-14 days post-vaccination |
| Occurrence of adverse events within 28 days after booster vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A rehabilitation centre in Wuhan | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38038866 | Derived | Jia S, Zhang J, Wang X, Zhang Z, Wang B, Zhang J, Jiang H, Guo G, Wang Y, Wan J, Wang W, Hou L, Zhu F. Safety and Immunogenicity of Homologous Recombinant Adenovirus Type 5-Vectored COVID-19 Vaccine Booster Dose in Healthy Adults Aged 18-60 Years: a Single-Center, Open-Label Trial. Infect Dis Ther. 2023 Dec;12(12):2757-2769. doi: 10.1007/s40121-023-00892-0. Epub 2023 Dec 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Occurrence of adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine |
| 0-28 days post-vaccination |
| Occurrence of serious adverse events within 28 days after booster vaccination | Occurrence of serious adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 0-28 days post-vaccination |
| Occurrence of serious adverse events within 6 months after booster vaccination | Occurrence of serious adverse events within 6 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 6 months post-vaccination |
| Occurrence of serious adverse events within 12 months after booster vaccination | Occurrence of serious adverse events within 12 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 12 months post-vaccination |
| Changes in laboratory test indicators before and 1 day after vaccination | Changes in laboratory test indicators (including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, ALT, AST, total bilirubin, fasting blood glucose, creatinine) before and 1 day after vaccination | 1 day post-vaccination |
| Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination | Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 14 days, 28 days, 6 months and 12 months post-vaccination |
| Cellular immunity at day 14 after booster vaccination | Cellular immunity at day 14 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine | 14 days post-vaccination |