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| Name | Class |
|---|---|
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
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The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50L Scale (Age 18-59) | Experimental | Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. |
|
| 500L Scale (Age 18-59) | Experimental | Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. |
|
| 800L Scale (Age 18-59) | Experimental | Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. |
|
| 800L Scale Lot 1 (Age 13-17) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
|
| 800L Scale Lot 2 (Age 13-17) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
|
| 800L Scale Lot 3 (Age 13-17) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml | Biological | Containing 0.5E10vp |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT of anti SARS-CoV-2 specific neutralizing antibody | GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test). | 28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of SARS-CoV-2 neutralizing antibody | Seroconversion rate of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test). | 28 days after vaccination |
| GMI of SARS-CoV-2 neutralizing antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, MSD | Jiangsu Provincal Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Funing Center for Disease Control and Prevention | Yancheng | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37432025 | Derived | Wu YF, Wei MW, Wang RJ, Guo XL, Pan HX, Gao YC, Li XL, Wang X, Ma XM, Wan P, Zhou L, Zhu YW, Li JX, Zhu FC. Immunogenicity consistency and safety with different production scales of recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults: a randomized, double-blinded, immunobridging trial. Expert Rev Vaccines. 2023 Jan-Dec;22(1):662-670. doi: 10.1080/14760584.2023.2234997. |
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| Experimental |
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
|
| 800L Scale Lot 1 (Age 6-12) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
|
| 800L Scale Lot 2 (Age 6-12) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
|
| 800L Scale Lot 3 (Age 6-12) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml | Biological | Containing 0.3E10vp |
|
GMI of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
| 28 days after vaccination |
| GMT of SARS-CoV-2 S protein RBD antibody | GMT of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups | 28 days after vaccination |
| Seroconversion rate of SARS-CoV-2 S protein RBD antibody | Seroconversion rate of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups. | 28 days after vaccination |
| GMI of SARS-CoV-2 S protein RBD antibody | GMI of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups. | 28 days after vaccination |
| GMT of Ad5 vector neutralizing antibody | GMT of anti Ad5 vector neutralizing antibody responses post vaccination in all groups | 28 days after vaccination |
| GMI of Ad5 vector neutralizing antibody | GMI of Ad5 vector neutralizing antibody responses post vaccination in all groups | 28 days after vaccination |
| Stratified analysis on Ad5 vector neutralizing antibody | Stratified analysis based on the GMT of Ad5 vector neutralizing antibody responses post vaccination. | 28 days after vaccination |
| Incidence of Adverse Reactions/Events (AE/AR) | The occurance of Adverse Reactions/Events within 30 minutes post vaccination | Within 30 minutes after vaccination |
| Incidence of Adverse Reactions/Events (AE/AR) | The occurance of Adverse Reactions/Events (AE/AR) within 7 days post vaccination. | Within 0-7 days after vaccination |
| Incidence of Adverse Reactions/Events (AE/AR) | The occurance of Adverse Reactions/Events (AE/AR) within 28 days post vaccination. | Within 0-28 days after vaccination |
| Incidence of Serious Adverse Events (SAE) | Occurance of Serious Adverse Events (SAE) post vaccination. | Within 12 months after vaccination |
| Incidence of Adverse Events of Special Interest (AESI) | Occurance of Adverse Events of Special Interest (AESI) post vaccination. | Within 12 months after vaccination |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| C566578 | Alzheimer Disease 5 |
| 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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