Print

Purpose

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

Condition

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

ArmDescriptionAssigned Intervention
Experimental
Single Low Dose AdCOVID
  • Biological: AdCOVID
    Administered intranasally
Experimental
Single Medium Dose AdCOVID
  • Biological: AdCOVID
    Administered intranasally
Experimental
Single High Dose AdCOVID
  • Biological: AdCOVID
    Administered intranasally
Experimental
Two Low Doses AdCOVID
  • Biological: AdCOVID
    Administered intranasally
Experimental
Two Medium Doses AdCOVID
  • Biological: AdCOVID
    Administered intranasally
Experimental
Two High Doses AdCOVID
  • Biological: AdCOVID
    Administered intranasally
Placebo Comparator
Single Dose Placebo
  • Other: Placebo
    Administered intranasally
Placebo Comparator
Two Dose Placebo
  • Other: Placebo
    Administered intranasally

Recruiting Locations

More Details

NCT ID
NCT04679909
Status
Completed
Sponsor
Altimmune, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.