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)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Evaluate the induction of anti-Ad7 neutralizing activity by measuring the Ad7 seroconversion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
- •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
- •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.
研究组 & 干预措施
PXVX0047 treatment group
Subjects will receive PXVX0047 vaccine and Teva Placebo-to-Match
干预措施: PXVX0047 Vaccine (Biological)
Teva Ad4/Ad7 treatment group
Subjects will receive Teva Ad4/Ad7 vaccine and PXVX0047 Placebo-to-Match
干预措施: Teva Ad4/Ad7 Vaccine (Biological)
结局指标
主要结局
Evaluate the induction of anti-Ad7 neutralizing activity by measuring the Ad7 seroconversion rate
时间窗: 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
Evaluate the induction of anti-Ad4 neutralizing activity by measuring the Ad4 and Ad7 seroconversion rate
时间窗: 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
Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events
时间窗: 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
Evaluate the safety and tolerability of PXVX0047 by documenting the incidence and severity of adverse events that are not solicited.
时间窗: From Day 1 through Day 29
Unsolicited adverse events include clinical significant laboratory abnormalities
次要结局
- 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 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 presence of Ad4 viremia(Days 4, 8, 15, 22, and 29)
- Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad7 viremia(Days 4, 8, 15, 22, and 29)
- Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad4 seroconversion rates(Through Day 57)
- Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad4 viruses(Through Day 57)
- 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 immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad7 viruses(Through Day 57)
- Evaluate the immunogenicity of PXVX0047 by measuring Ad7 seroconversion rates(Through Day 57)
- Evaluate the immunogenicity of PXVX0047 by measuring Ad4 seroconversion rates(Through Day 57)
- Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad7 seroconversion rates(Through Day 57)
- Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad4 viruses(At Days 29 and 57.)
- Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad7 viruses(At Days 29 and 57.)
- Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer(Through Day 57)