Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Sponsored by Altimmune, Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the participation requirements?
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