A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047

March 14, 2024 updated by: Emergent BioSolutions

A Phase 1 Two-Arm, Randomized, Double-blind, Active-controlled Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral)

PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.

Study Overview

Status

Status

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

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.
25

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
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female
  • Age 18 to 35
  • Seronegative for Ad4 and Ad7 by CPE-based assay
  • (if female of childbearing potential) Using an acceptable method of contraception
  • If male, subject agrees to use a highly effective method of contraception with female sexual partners of childbearing potential
  • Able and willing to provide informed consent for study participation

Exclusion Criteria:

  • Current acute febrile illness
  • Current acute gastrointestinal illness
  • Clinically significant cardiac, respiratory, or gastrointestinal disease
  • (if female of childbearing potential) Pregnant or nursing, or who plan to become pregnant or nurse during the study
  • Persons with occupations which may create an increased risk of transmission of vaccine virus (including but not limited to health care workers, child or elderly care providers, food handlers or preparers) who also have expected occupational contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
  • Expected household contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
  • Laboratory evidence of infection with Hepatitis B/C or HIV.
  • History of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
  • Inability to swallow capsules or tablets whole without chewing or crushing.
  • Immunosuppressed individuals, including those treated or planned to be treated with systemic immunosuppressive medications within the 30 days prior to enrollment through 30 days after study treatment.
  • Concomitant or planned use of other vaccines, investigational agents, cidofovir, ribavirin, or medications expected by the Investigator to have antiviral activity against adenovirus within 30 days prior to enrollment through Day 29.
  • Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
  • Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.

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: Triple

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: PXVX0047 treatment group
Subjects will receive PXVX0047 vaccine and Teva Placebo-to-Match
Biological: PXVX0047 Vaccine
PXVX0047 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in PXVX 0047 are unattenuated strains propagated in A549 human adenocarcinomic alveolar basal epithelial cells.
Active Comparator: Teva Ad4/Ad7 treatment group
Subjects will receive Teva Ad4/Ad7 vaccine and PXVX0047 Placebo-to-Match
Biological: Teva Ad4/Ad7 Vaccine
Teva Ad4/Ad7 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in Teva Ad4/Ad7 are unattenuated strains propagated in WI-38 human diploid fibroblast cells.

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
Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events
Time Frame: From Day 1 through Day 15
Incidence of severity of solicited adverse events include abdominal pain, nausea, vomiting, diarrhea, cough, nasal congestion, dyspnea, sore throat, headache, fever fatigue chills myalgia, arthralgia
From Day 1 through Day 15
Evaluate the safety and tolerability of PXVX0047 by documenting the incidence and severity of adverse events that are not solicited.
Time Frame: From Day 1 through Day 29
Unsolicited adverse events include clinical significant laboratory abnormalities
From Day 1 through Day 29
Evaluate the induction of anti-Ad4 neutralizing activity by measuring the Ad4 and Ad7 seroconversion rate
Time Frame: From Day 1 to Day 29
The Ad4 seroconversion rate is defined as the percent of subjects seroconverted (i.e. with a 4-fold or greater rise over baseline in neutralizing antibody titer) to Ad4 as determined by cytopathic-effect (CPE)-based assay
From Day 1 to Day 29
Evaluate the induction of anti-Ad7 neutralizing activity by measuring the Ad7 seroconversion rate
Time Frame: From Day 1 to Day 29
The Ad7 seroconversion rate is defined as the percent of subjects seroconverted (i.e. with a 4-fold or greater rise over baseline in neutralizing antibody titer) to Ad7 as determined by cytopathic-effect (CPE)-based assay
From Day 1 to Day 29

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
Measure Description
Time Frame
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the GI tract
Time Frame: Days 4, 8, 15, 22, and 29
Shedding of Ad4 via the GI tract, as assessed by rectal swabs
Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the GI tract
Time Frame: Days 4, 8, 15, 22, and 29
Shedding of Ad7 via the GI tract, as assessed by rectal swabs
Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the respiratory tract
Time Frame: Days 4, 8, 15, 22, and 29
Shedding of Ad4 via the respiratory tract, as assessed by throat swabs.
Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the respiratory tract
Time Frame: Days 4, 8, 15, 22, and 29
Shedding of Ad7 via the respiratory tract, as assessed by throat swabs.
Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad4 viremia
Time Frame: Days 4, 8, 15, 22, and 29
Presence of Ad4 viremia in the blood
Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad7 viremia
Time Frame: Days 4, 8, 15, 22, and 29
Presence of Ad7 viremia in the blood
Days 4, 8, 15, 22, and 29
Evaluate the immunogenicity of PXVX0047 by measuring Ad4 seroconversion rates
Time Frame: Through Day 57
The Ad4 seroconversion rates, measured independently, determined by luciferase and CPE-based assays
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring Ad7 seroconversion rates
Time Frame: Through Day 57
The Ad7 seroconversion rates, measured independently, determined by luciferase and CPE-based assays
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad4 seroconversion rates
Time Frame: Through Day 57
The cumulative Ad4 seroconversion rates, measured independently, where cumulative seroconversion through a particular visit is defined as having seroconverted at or prior to that visit.
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad7 seroconversion rates
Time Frame: Through Day 57
The cumulative Ad7 seroconversion rates, measured independently, where cumulative seroconversion through a particular visit is defined as having seroconverted at or prior to that visit.
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
Time Frame: Through Day 57
The geometric mean titer (GMT) of neutralizing antibodies to Ad4, measured independently
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
Time Frame: Through Day 57
The geometric mean titer (GMT) of neutralizing antibodies to Ad7, measured independently
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad4 viruses
Time Frame: Through Day 57
The fold-rise over baseline in neutralizing antibodies to Ad4, measured independently
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad7 viruses
Time Frame: Through Day 57
The fold-rise over baseline in neutralizing antibodies to Ad7, measured independently
Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad4 viruses
Time Frame: At Days 29 and 57.
The cellular immune responses to Ad4, measured independently
At Days 29 and 57.
Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad7 viruses
Time Frame: At Days 29 and 57.
The cellular immune responses to Ad7, measured independently
At Days 29 and 57.

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.
Emergent BioSolutions

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Walter Reed Army Institute of Research (WRAIR)

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.
May 1, 2017

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.
November 27, 2017

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.
November 27, 2017

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).
May 15, 2017

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.
May 17, 2017

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.
May 19, 2017

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.
March 18, 2024

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.
March 14, 2024

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.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • PXVX-AD-047-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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