Clinical trial NCT04679909: Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: COVID-19
SARS-CoV-2
Intranasal Vaccine
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Reactogenicity
timeFrame: For 7 days after vaccination
measure: Adverse Events (AEs)
timeFrame: Day 1 to Day 57
Secondary outcomes:
measure: Anti-SARS-CoV-2 spike IgG antibody levels
timeFrame: Day 1 to Day 366
measure: Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus
timeFrame: Day 1 to Day 366
Other outcomes:
measure: Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)
timeFrame: Day 1 to Day 366
measure: Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers)
timeFrame: Day 1 to Day 366
Locations:
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
References: