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

Sponsor
Altimmune, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04679909
Collaborator
(none)
92
Enrollment
6
Locations
8
Arms
11.2
Anticipated Duration (Months)
15.3
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: AdCOVID
  • Other: Placebo
 Phase 1

Study Design

Study Type:
Interventional
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 :
Feb 25, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Reactogenicity [For 7 days after vaccination]

    Counts and percentages of subjects with local and systemic events

  2. Adverse Events (AEs) [Day 1 to Day 57]

    Counts and percentages of subjects with AEs

Secondary Outcome Measures

  1. Anti-SARS-CoV-2 spike IgG antibody levels [Day 1 to Day 366]

  2. Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus [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) [Day 1 to Day 366]

  2. Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers) [Day 1 to Day 366]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 AGA Clinical Trials Hialeah Florida United States 33012
2 Optimal Research Melbourne Florida United States 32934
3 Optimal Research Peoria Illinois United States 61614
4 Optimal Research Rockville Maryland United States 20850
5 Optimal Research Austin Texas United States 78705
6 Clinical Trials of Texas San Antonio Texas United States 78229

Sponsors and Collaborators

  • Altimmune, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Altimmune, Inc.
ClinicalTrials.gov Identifier:
NCT04679909
Other Study ID Numbers:
  • ALT-501-101
First Posted:
Dec 22, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Feb 8, 2022