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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04679909
Recruitment Status : Active, not recruiting
First Posted : December 22, 2020
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: AdCOVID Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Reactogenicity [ Time Frame: For 7 days after vaccination ]
    Counts and percentages of subjects with local and systemic events

  2. Adverse Events (AEs) [ Time Frame: Day 1 to Day 57 ]
    Counts and percentages of subjects with AEs


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

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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679909


Locations
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United States, Florida
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Optimal Research
Melbourne, Florida, United States, 32934
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, Texas
Optimal Research
Austin, Texas, United States, 78705
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Altimmune, Inc.
More Information
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Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT04679909    
Other Study ID Numbers: ALT-501-101
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Altimmune, Inc.:
COVID-19
SARS-CoV-2
Intranasal Vaccine