Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CanSino Biologics Inc. | INDUSTRY |
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
| Hubei Provincial Center for Disease Control and Prevention | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | 1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 |
|
| Arm 2 | Active Comparator | 5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 |
|
| Arm 3 | Placebo Comparator | Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse reactions | 0-14 days post vaccination | |
| Anti SARS-CoV-2 S IgG antibody response(ELISA) | 28 days post vaccination | |
| Neutralizing antibody response to SARS-CoV-2 | 28 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | 0-28 days post vaccination | |
| Occurrence of serious adverse reaction | 0-6 months post vaccination | |
| Anti SARS-CoV-2 S IgG antibody response(ELISA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, MD | Jiangsu Province Centers of Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei Provincial Center for Disease Control and Prevention | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37428653 | Derived | Feng JL, Wang WJ, Jin PF, Zheng H, Jin LR, Xia X, Zhang XY, Li ZP, Li JX, Zhu FC. Comparison of antibody persistency through one year between one-dose and two-dose regimens of Ad5-nCoV vaccine for COVID-19. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230760. doi: 10.1080/21645515.2023.2230760. | |
| 32702299 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706167 | Ad5-nCoV vaccine |
Not provided
Not provided
Not provided
| Zhongnan Hospital |
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Intramuscular injection |
|
|
| 0, 14 days and 6 months post vaccination |
| Neutralizing antibody response to SARS-CoV-2 | 0 and 6 months post vaccination |
| Neutralizing antibody response to Ad5-vector | 0, 28 days and 6 months post vaccination |
| IFN-γ ELISpot responses to SARS-CoV-2 spike protein | 0 and 28 days post vaccination |
| Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |