Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Key facts
- Study ID
- NCT04679909
- Run by
- Altimmune, Inc.
- People needed
- 92
- Starts
- 2021-02-25
- Expected to finish
- 2022-12-21
- Last updated by the study team
- 2023-08-14
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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