Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
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
1 other identifier
interventional
92
1 country
6
Brief Summary
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Feb 2021
Longer than P75 for phase_1 healthy-volunteers
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2020
CompletedFirst Posted
Study publicly available on registry
December 22, 2020
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2022
CompletedAugust 14, 2023
August 1, 2023
9 months
December 21, 2020
August 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reactogenicity
Counts and percentages of subjects with local and systemic events
For 7 days after vaccination
Adverse Events (AEs)
Counts and percentages of subjects with AEs
Day 1 to Day 57
Secondary Outcomes (2)
Anti-SARS-CoV-2 spike IgG antibody levels
Day 1 to Day 366
Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus
Day 1 to Day 366
Other Outcomes (2)
Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)
Day 1 to Day 366
Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers)
Day 1 to Day 366
Study Arms (8)
Single Low Dose AdCOVID
EXPERIMENTALSingle Medium Dose AdCOVID
EXPERIMENTALSingle High Dose AdCOVID
EXPERIMENTALTwo Low Doses AdCOVID
EXPERIMENTALTwo Medium Doses AdCOVID
EXPERIMENTALTwo High Doses AdCOVID
EXPERIMENTALSingle Dose Placebo
PLACEBO COMPARATORTwo Dose Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Men and women ages 18 to 55 years, inclusive
- Good general health status
- Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not clinically significant by the investigator.
- For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
- Willingness to practice a highly effective method of contraception
- Ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period
You may not qualify if:
- Subjects at increased risk of exposure to SARS-CoV-2, including healthcare workers, emergency response personnel, and those with known contact with COVID-19 patients
- Pregnant or lactating women or planning to conceive a child during the next 3 months
- Body mass index (BMI) \> 30.0 kg/m2
- Acute COVID-19, a positive test result for SARS-CoV2 infection, a positive SARS-CoV-2 serology for prior SARS-CoV-2 infection at screening, or exposure within 14 days to an individual with acute COVID-19
- An acute respiratory illness
- Positive result for HIV, hepatitis B virus, or hepatitis C virus at screening
- Chronic or current cigarette smoking
- Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altimmune, Inc.lead
Study Sites (6)
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Optimal Research
Melbourne, Florida, 32934, United States
Optimal Research
Peoria, Illinois, 61614, United States
Optimal Research
Rockville, Maryland, 20850, United States
Optimal Research
Austin, Texas, 78705, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2020
First Posted
December 22, 2020
Study Start
February 25, 2021
Primary Completion
December 1, 2021
Study Completion
December 21, 2022
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share