Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Purpose
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Condition
- Healthy Volunteers
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
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Experimental Single Low Dose AdCOVID |
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Experimental Single Medium Dose AdCOVID |
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Experimental Single High Dose AdCOVID |
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Experimental Two Low Doses AdCOVID |
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Experimental Two Medium Doses AdCOVID |
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Experimental Two High Doses AdCOVID |
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Placebo Comparator Single Dose Placebo |
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Placebo Comparator Two Dose Placebo |
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Recruiting Locations
More Details
- NCT ID
- NCT04679909
- Status
- Completed
- Sponsor
- Altimmune, Inc.