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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 : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2020
First Posted Date  ICMJE December 22, 2020
Last Update Posted Date July 15, 2021
Actual Study Start Date  ICMJE February 25, 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Biological: AdCOVID
    Administered intranasally
  • Other: Placebo
    Administered intranasally
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 14, 2021)
92
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2020)
180
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04679909
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Altimmune, Inc.
Study Sponsor  ICMJE Altimmune, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Altimmune, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP