Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)

• ClinicalTrials.gov Identifier: NCT04679909
• Recruitment Status: Active, not recruiting
• First Posted: December 22, 2020
• Last Update Posted: February 8, 2022
• Sponsor: Altimmune, Inc.
• Information provided by (Responsible Party): Altimmune, Inc.

Tracking Information

• First Submitted Date: December 21, 2020
• First Posted Date: December 22, 2020
• Last Update Posted Date: February 8, 2022
• Actual Study Start Date: February 25, 2021
• Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 21, 2020)

• Reactogenicity [ Time Frame: For 7 days after vaccination ]
  Counts and percentages of subjects with local and systemic events
• Adverse Events (AEs) [ Time Frame: Day 1 to Day 57 ]
  Counts and percentages of subjects with AEs

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 21, 2020)

• Anti-SARS-CoV-2 spike IgG antibody levels [ Time Frame: Day 1 to Day 366 ]
• Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus [ Time Frame: Day 1 to Day 366 ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 21, 2020)

• Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot) [ Time Frame: Day 1 to Day 366 ]
• Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers) [ Time Frame: Day 1 to Day 366 ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• Brief Summary: A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Healthy Volunteers

Intervention

• Biological: AdCOVID
  Administered intranasally
• Other: Placebo
  Administered intranasally

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 14, 2021): 92
• Original Estimated Enrollment (submitted: December 21, 2020): 180
• Estimated Study Completion Date: February 2022
• Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04679909
• Other Study ID Numbers: ALT-501-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Altimmune, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Altimmune, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Altimmune, Inc.
• Verification Date: February 2022