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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: AdCOVID; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33012
      • Aga Clinical Trials
    • Melbourne, Florida, United States, 32934
      • Optimal Research
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Optimal Research
  • Texas
    • Austin, Texas, United States, 78705
      • Optimal Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactogenicity	Counts and percentages of subjects with local and systemic events	For 7 days after vaccination
Adverse Events (AEs)	Counts and percentages of subjects with AEs	Day 1 to Day 57

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Intranasal Vaccine
• Other Study ID Numbers: ALT-501-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No