Healthy Volunteers
Conditions
Keywords
COVID-19, SARS-CoV-2, Intranasal Vaccine
Brief summary
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Interventions
BIOLOGICALAdCOVID
Administered intranasally
OTHERPlacebo
Administered intranasally
Sponsors
Altimmune, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactogenicity | For 7 days after vaccination | Counts and percentages of subjects with local and systemic events |
| Adverse Events (AEs) | Day 1 to Day 57 | Counts and percentages of subjects with AEs |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed