Status:
COMPLETED
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Lead Sponsor:
Altimmune, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04679909
Start Date
February 25 2021
End Date
December 21 2022
Last Update
August 14 2023
Active Locations (6)
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1
AGA Clinical Trials
Hialeah, Florida, United States, 33012
2
Optimal Research
Melbourne, Florida, United States, 32934
3
Optimal Research
Peoria, Illinois, United States, 61614
4
Optimal Research
Rockville, Maryland, United States, 20850