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

NCT03160339 | Terminated Phase 1 FDA Drug

• 1 other identifier: PXVX-AD-047-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Adenoviral Infection

Outcome Measures

Primary Outcomes (4)

• Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events

  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.

  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

  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

  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 Outcomes (16)

• Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the GI tract

  Days 4, 8, 15, 22, and 29

• Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the GI tract

  Days 4, 8, 15, 22, and 29

• Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the respiratory tract

  Days 4, 8, 15, 22, and 29

• Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the respiratory tract

  Days 4, 8, 15, 22, and 29

• Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad4 viremia

  Days 4, 8, 15, 22, and 29

Study Arms (2)

PXVX0047 treatment group

EXPERIMENTAL

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

Biological: PXVX0047 Vaccine

Teva Ad4/Ad7 treatment group

ACTIVE COMPARATOR

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

Biological: Teva Ad4/Ad7 Vaccine

Interventions

PXVX0047 Vaccine 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.

PXVX0047 treatment group

Teva Ad4/Ad7 Vaccine 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.

Teva Ad4/Ad7 treatment group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Beaty S, Collins N, Karasavvas N, Kuschner R, Hang J, Adhikari A, Maljkovic Berry I, Fung C, Walls S, Betancourt E, Mendy J, Lock M, Gierman E, Bennett S, Shabram P, Warfield K. A Phase 1 Two-Arm, Randomized, Double-Blind, Active-Controlled Study of Live, Oral Plasmid-Derived Adenovirus Type 4 and Type 7 Vaccines in Seronegative Adults. Vaccines (Basel). 2023 Jun 12;11(6):1091. doi: 10.3390/vaccines11061091.

  PMID: 37376480 DERIVED

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 19, 2017
• Study Start: May 1, 2017
• Primary Completion: November 27, 2017
• Study Completion: November 27, 2017
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (2)