NCT01960686已完成2 期
A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novavax
- 入组人数
- 720
- 试验地点
- 20
- 主要终点
- Assessment of Safety
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the following criteria to be eligible to participate:
- •Healthy adult females, ≥ 18 and ≤ 35 years of age. "Healthy" shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability.
- •Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives.
- •Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible.
- •Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below.
- •Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible.
- •Willing and able to give informed consent prior to study enrollment.
- •Able to comply with study requirements.
- •Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.
排除标准
- •Subjects will be excluded if they fulfill any of the following criteria:
- •Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
- •History of a serious reaction to any prior vaccination.
- •Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
- •Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- •Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- •Donated blood within 3 weeks of the planned date of first vaccination.
- •Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
- •Known disturbance of coagulation.
- •Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
- •Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- •Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
结局指标
主要结局
Assessment of Safety
时间窗: Day 0 to Day 182
Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
时间窗: Day 0 to Day 56
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include: * Geometric mean concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise (GMFR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
次要结局
- Immunogenicity based on antibodies sharing specificity with Palivizumab(Day 0 to 91)
- Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time(Day 0 to Day 91)
- Immunogenicity based on neutralizing antibody titer(Day 0 to Day 56)
研究者
研究点 (20)
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