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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 I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1a Phase I low 2 doses | Experimental | Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo |
|
| A1b Phase I placebo low 2 doses | Placebo Comparator | Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo |
|
| A2a Phase I medium 2 doses | Experimental | Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo |
|
| A2b Phase I placebo medium 2 doses | Placebo Comparator | Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo |
|
| A3a Phase I high 2 doses | Experimental | Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation | Biological | Aerogen Solo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Reactions (AR) | The occurrence of Adverse Reactions (AR) in all groups | 0-14 days after each vaccination |
| Incidence of Serious Adverse Events (SAE) | The occurrence of Serious Adverse Events (SAE) in all groups | Within the first and final vaccination up until 12 months after the final vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events/Reactions (AE/AR) | The occurence of Adverse Events/Reactions (AE/AR) in all groups | Within 0-7 days after each vaccination |
| Incidence of Adverse Events/Reactions (AE/AR) |
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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 |
|---|---|---|---|---|---|---|
| Jiangsu Provincal Center for Disease Control and Prevention | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38543926 | Derived | Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292. doi: 10.3390/vaccines12030292. | |
| 37202147 | Derived |
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| A3b Phase I placebo high 2 doses |
| Placebo Comparator |
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo |
|
| A4a Phase I combine 2 doses | Experimental | 1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart |
|
| A4b Phase I placebo combine 2 doses | Placebo Comparator | 6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart |
|
| A5a Phase I single dose | Experimental | Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo |
|
| A5b Phase I placebo single dose | Placebo Comparator | 6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo |
|
| B1a Phase II low 2 doses | Experimental | Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo |
|
| B1b Phase II placebo low 2 doses (18-59) | Placebo Comparator | Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo |
|
| B2a Phase II medium 2 doses | Experimental | Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo |
|
| B2b Phase II placebo medium 2 doses | Placebo Comparator | Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo |
|
| B3a Phase II high 2 doses | Experimental | Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo |
|
| B3b Phase II placebo high 2 doses | Placebo Comparator | Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo |
|
| B4a Phase II combine 2 doses | Experimental | 1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart |
|
| B4b Phase II placebo combine 2 doses | Placebo Comparator | Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart |
|
| B5a Phase II intramuscular single dose | Experimental | Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection |
|
| B5b Phase II placebo intramuscular single dose | Placebo Comparator | placebo containing 0 vp, 1 dose Intramuscular Injection |
|
| B6a Phase II Aerogen Solo single dose | Experimental | Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo |
|
| B6b Phase II placebo Aerogen Solo single dose | Placebo Comparator | placebo containing 0 vp, 1 dose Aerogen Solo |
|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) | Biological | Intramuscular administration |
|
| Placebo for Inhalation | Biological | Aerogen Solo |
|
| Placebo | Biological | Intramuscular administration |
|
The occurence of Adverse Events/Reactions (AE/AR) in all groups
| Within 0-28 days after each vaccination |
| Changes in laboratory test indicators | Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups | 4 days after each vaccination |
| GMT of Covid-19 S protein RBD specific antibody | GMT of S protein RBD specific antibody by ELISA | Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose |
| Seroconversion rate of Covid-19 S protein RBD specific antibody | Seroconversion rate of S protein RBD specific antibody by ELISA | Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose |
| GMI of Covid-19 S protein RBD specific antibody | GMI of S protein RBD specific antibody by ELISA | Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose |
| GMT of SARS-CoV-2 neutralizing antibody | GMT of SARS-CoV-2 neutralizing antibody against pseudovirus | Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose |
| Seroconversion rate of SARS-CoV-2 neutralizing antibody | Seroconversion rate of SARS-CoV-2 neutralizing antibody against pseudovirus | Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose |
| GMI of SARS-CoV-2 neutralizing antibody | GMI of SARS-CoV-2 neutralizing antibody against pseudovirus | Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose |
| GMT of SARS-CoV-2 neutralizing antibody | 28 days after the final vaccination |
| Seroconversion rate of SARS-CoV-2 neutralizing antibody | 28 days after the final vaccination |
| Cellular immune response | The positive rate of IFN-γ stimulated by S protein ELISpot | Before the first dose, 14 days after the first dose |
| Cellular immune response | The positive rate of TNF-α stimulated by S protein ELISpot | Before the first dose, 14 days after the first dose |
| Cellular immune response | The positive rate of IL-5 stimulated by S protein ELISpot | Before the first dose, 14 days after the first dose |
| Cellular immune response | The positive rate of IL-4 stimulated by S protein ELISpot | Before the first dose, 14 days after the first dose |
| Cellular immune response | The positive rate of IL-13 stimulated by S protein ELISpot | Before the first dose, 14 days after the first dose |
| Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134. |
| 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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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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