A Phase 2 Open-Label Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
研究概览
简要总结
The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).
详细描述
Primary Objectives:
- To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 (40 µg CHIKV VLP, alum-adjuvanted) as measured 21 days (Day 22) after vaccination.
- To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 as measured 7 days (Day 8), 14 days (Day 15), and 56 days (Day 57) after vaccination.
Secondary Objectives:
- To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide informed consent voluntarily signed by participant.
- •Any gender, 18 to 45 years of age (inclusive).
- •Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments.
- •Women who are either:
- •(i). Not of childbearing potential (CBP): pre-menarche, anatomically sterile, or post-menopausal (defined as ≥12 months without menses) or (ii). Meeting all the following criteria: Negative urine pregnancy test at screening visit; and Negative urine pregnancy test immediately prior to dosing at Day 1; and using an acceptable method of contraception (if female of childbearing potential) for the duration of participation, such as: Hormonal contraceptives (e.g., implants, pills, patches) initiated ≥ 30 days prior to dosing or; Intrauterine device (IUD) inserted ≥30 days prior to dosing or; double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap).
排除标准
- •Currently pregnant, breastfeeding, or planning to become pregnant during the study.
- •Body Mass Index (BMI) ≥35 kg/m
- •Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
- •History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP).
- •History of known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
- •Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six months prior to screening through Day
- •Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day
- •Acute disease within the last 14 days (participants with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed).
- •Clinically significant cardiac, pulmonary, respiratory, rheumatologic, or other chronic disease, in the opinion of the Investigator. This may include chronic illness requiring hospitalization in the last one month prior to screening.
- •Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
- •Receipt or anticipated receipt of any vaccine from 30 days prior to screening through Day
- •Prior receipt of an investigational CHIKV vaccine/product.
- •Detectable baseline anti-CHIKV IgG antibody as determined by ELISA.
- •Any other condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study, creates an unacceptable risk to the participant, or may interfere with the conduct of the study or validity of the data.
- •Restricted venous access that would prevent the collection of plasma and serum necessary for participation.
- •Weight <110 pounds.
结局指标
主要结局
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
时间窗: 56 days post vaccination
GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57
CHIKV SNA GMT (Geometric Mean Titer) at Day 22
时间窗: 21 days post vaccination
CHIKV SNA GMT and Associated 95% CI at Day 22
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
时间窗: 56 days post vaccination
CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57
CHIKV SNA GMTs at Days 8, 15, and 57
时间窗: 56 days post vaccination
CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
时间窗: 56 days post vaccination
GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
时间窗: 56 days post vaccination
GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
时间窗: 56 days post vaccination
Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57
CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22
时间窗: 21 days post vaccination
CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
时间窗: 56 days post vaccination
CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
时间窗: 56 days post vaccination
CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
次要结局
- Incidence of Adverse Events of Special Interest (AESI) Through Day 183(182 days post vaccination)
- Incidence of Solicited Adverse Events (AE) Through Day 8(7 days post vaccination)
- Incidence of Unsolicited AEs Through Day 29(28 days post vaccination)
- Incidence of Serious Adverse Events (SAEs) Through Day 183(182 days post vaccination)