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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

ALT-501-101

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.

What are the participation requirements?

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

No

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

Locations

Location

Status