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

August 9, 2023 updated by: Altimmune, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reactogenicity
Time Frame: For 7 days after vaccination
Counts and percentages of subjects with local and systemic events
For 7 days after vaccination
Adverse Events (AEs)
Time Frame: Day 1 to Day 57
Counts and percentages of subjects with AEs
Day 1 to Day 57

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Anti-SARS-CoV-2 spike IgG antibody levels
Time Frame: Day 1 to Day 366
Day 1 to Day 366
Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus
Time Frame: Day 1 to Day 366
Day 1 to Day 366

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)
Time Frame: Day 1 to Day 366
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
Day 1 to Day 366

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Altimmune, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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