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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Adenoviral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PXVX0047 treatment group

Subjects will receive PXVX0047 vaccine and Teva Placebo-to-Match

Group Type EXPERIMENTAL

PXVX0047 Vaccine

Intervention Type BIOLOGICAL

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.

Teva Ad4/Ad7 treatment group

Subjects will receive Teva Ad4/Ad7 vaccine and PXVX0047 Placebo-to-Match

Group Type ACTIVE_COMPARATOR

Teva Ad4/Ad7 Vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes