A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults
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ClinicalTrials.gov Identifier: NCT04552366 |
Recruitment Status : Unknown
Verified September 2020 by Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China.
Recruitment status was: Active, not recruiting
First Posted : September 17, 2020
Last Update Posted : December 7, 2020
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Sponsor:
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Collaborator:
Zhongnan Hospital
Information provided by (Responsible Party):
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Tracking Information | |||||
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First Submitted Date ICMJE | September 15, 2020 | ||||
First Posted Date ICMJE | September 17, 2020 | ||||
Last Update Posted Date | December 7, 2020 | ||||
Actual Study Start Date ICMJE | September 29, 2020 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults | ||||
Official Title ICMJE | A Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults Aged 18 Years and Older | ||||
Brief Summary | This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older. | ||||
Detailed Description | A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | COVID-19 | ||||
Intervention ICMJE | Biological: Ad5-nCoV
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
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Study Arms ICMJE |
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Publications * | Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1654-1664. doi: 10.1016/S1473-3099(21)00396-0. Epub 2021 Jul 26. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Actual Enrollment ICMJE |
149 | ||||
Original Estimated Enrollment ICMJE |
168 | ||||
Estimated Study Completion Date ICMJE | June 30, 2021 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria for the first vaccination:
Exclusion Criteria for the second vaccination:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04552366 | ||||
Other Study ID Numbers ICMJE | AMMS85-2004 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Zhongnan Hospital | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |