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| Name | Class |
|---|---|
| Beijing Institute of Biotechnology | OTHER |
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
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This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above.
The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine .
The immunization schedule is two doses intramuscular injections (deltoid).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MID A | Experimental | 20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration |
|
| MID B | Placebo Comparator | 10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration |
|
| MIN A | Experimental | 100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration |
|
| MIN B | Placebo Comparator | 50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration |
|
| OLD A | Experimental | 100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) | Biological | Intramuscular other name:Ad5-nCoV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety indexes of adverse reactions | Occurrence of adverse reactions post vaccination | within 14 days post each vaccination |
| Immunogencity indexes of GMT | Evaluate the Geometric mean titer (GMT) of IgG antibody | Day 28 post the second vaccination |
| Immunogencity indexes of neutralizing antibody | Evaluate the Geometric mean titer (GMT) of neutralizing antibody | Day 28 post the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety indexes of adverse events | Occurrence of adverse reactions post-vaccination | Day 0-7,0-14,0-28 post each vaccination |
| Safety indexes of Hematological examination measures(Hemoglobin, WBC) |
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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 |
|---|---|---|---|---|---|---|
| Taixing City center for Disease Control and Prevention | Taizhou | Jiangsu | 210000 | 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. | |
| 34551104 | Derived |
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| OLD B | Experimental | 100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration |
|
| OLD C | Placebo Comparator | 50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration |
|
| EBOV A | Experimental | 34 participants, Ad5-nCoV , two doses, Intramuscular administration |
|
| EBOV B | Placebo Comparator | 17 participants, Ad5-nCoV , two doses, Intramuscular administration |
|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo | Biological | Intramuscular other name:Ad5-nCoV |
|
Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
| pre-vaccination, day 4 post each vaccination |
| Safety indexes of Blood routine measures(ALT, AST) | Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group) | pre-vaccination, day 4 post each vaccination |
| Safety indexes of SAE | Occurrence of serious adverse events post-vaccination | Within 6 months post the second vaccination |
| Immunogencity indexes of GMT | Evaluate the Geometric mean titer of IgG antibody | Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination |
| Immunogencity indexes of neutralizing antibody | Evaluate the Geometric mean titer (GMT) of neutralizing antibody | Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination |
| Immunogencity indexes of cellular immune | Number of cell-mediated immune response against SARS-CoV-2(IL-2) | Day 28 post the first vaccination, pre and day 28 post the second vaccination |
| Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, Hou L, Li J, Wang X, Wu S, Wang Y, Gou J, Huang H, Wu H, Wang X, Chen W. Safety and Immunogenicity of a Recombinant Adenovirus Type-5-Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged >/=6 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial. Clin Infect Dis. 2022 Aug 24;75(1):e783-e791. doi: 10.1093/cid/ciab845. |
| 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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