Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04679909 |
Recruitment Status :
Active, not recruiting
First Posted : December 22, 2020
Last Update Posted : February 8, 2022
|
Sponsor:
Altimmune, Inc.
Information provided by (Responsible Party):
Altimmune, Inc.
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | December 21, 2020 | ||||
First Posted Date ICMJE | December 22, 2020 | ||||
Last Update Posted Date | February 8, 2022 | ||||
Actual Study Start Date ICMJE | February 25, 2021 | ||||
Estimated Primary Completion Date | February 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
|
||||
Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study) | ||||
Official Title ICMJE | A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses | ||||
Brief Summary | A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
||||
Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
92 | ||||
Original Estimated Enrollment ICMJE |
180 | ||||
Estimated Study Completion Date ICMJE | February 2022 | ||||
Estimated Primary Completion Date | February 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04679909 | ||||
Other Study ID Numbers ICMJE | ALT-501-101 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Altimmune, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Altimmune, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Altimmune, Inc. | ||||
Verification Date | February 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |