Official Title
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.

Active, not recruiting
Healthy Volunteers

Biological: AdCOVID

Administered intranasally

Other: Placebo

Administered intranasally

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
United States
Locations

AGA Clinical Trials
Hialeah, Florida, United States

Optimal Research
Melbourne, Florida, United States

Optimal Research
Peoria, Illinois, United States

Optimal Research
Rockville, Maryland, United States

Optimal Research
Austin, Texas, United States

Clinical Trials of Texas
San Antonio, Texas, United States

Altimmune, Inc.
NCT Number
Keywords
Covid-19
SARS-CoV-2
Intranasal Vaccine