- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160339
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
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: PXVX0047 treatment group
Subjects will receive PXVX0047 vaccine and Teva Placebo-to-Match
|
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
|
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
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
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
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Presence of Ad4 viremia in the blood
|
Days 4, 8, 15, 22, and 29
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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
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Evaluate the immunogenicity of PXVX0047 by measuring Ad4 seroconversion rates
Time Frame: Through Day 57
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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
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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.
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Through Day 57
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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
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Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
Time Frame: Through Day 57
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The geometric mean titer (GMT) of neutralizing antibodies to Ad4, measured independently
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Through Day 57
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Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
Time Frame: Through Day 57
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The geometric mean titer (GMT) of neutralizing antibodies to Ad7, measured independently
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Through Day 57
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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
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Through Day 57
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Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad4 viruses
Time Frame: At Days 29 and 57.
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The cellular immune responses to Ad4, measured independently
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At Days 29 and 57.
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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
Collaborators
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)
May 1, 2017
Primary Completion (Actual)
November 27, 2017
Study Completion (Actual)
November 27, 2017
Study Registration Dates
First Submitted
May 15, 2017
First Submitted That Met QC Criteria
May 17, 2017
First Posted (Actual)
May 19, 2017
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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