Clinical trial NCT03160339: A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Adenoviral Infection
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
First posted: 2017-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events
timeFrame: From Day 1 through Day 15
measure: Evaluate the safety and tolerability of PXVX0047 by documenting the incidence and severity of adverse events that are not solicited.
timeFrame: From Day 1 through Day 29
measure: Evaluate the induction of anti-Ad4 neutralizing activity by measuring the Ad4 and Ad7 seroconversion rate
timeFrame: From Day 1 to Day 29
measure: Evaluate the induction of anti-Ad7 neutralizing activity by measuring the Ad7 seroconversion rate
timeFrame: From Day 1 to Day 29
Secondary outcomes:
measure: Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the GI tract
timeFrame: Days 4, 8, 15, 22, and 29
measure: Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the GI tract
timeFrame: Days 4, 8, 15, 22, and 29
measure: Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the respiratory tract
timeFrame: Days 4, 8, 15, 22, and 29
measure: Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the respiratory tract
timeFrame: Days 4, 8, 15, 22, and 29
measure: Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad4 viremia
timeFrame: Days 4, 8, 15, 22, and 29
measure: Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad7 viremia
timeFrame: Days 4, 8, 15, 22, and 29
measure: Evaluate the immunogenicity of PXVX0047 by measuring Ad4 seroconversion rates
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring Ad7 seroconversion rates
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad4 seroconversion rates
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad7 seroconversion rates
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad4 viruses
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad7 viruses
timeFrame: Through Day 57
measure: Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad4 viruses
timeFrame: At Days 29 and 57.
measure: Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad7 viruses
timeFrame: At Days 29 and 57.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References: