A Randomized, Observer-Blinded, Phase I Study to Assess the Safety and Immunogenicity of Vi-DT Conjugate Vaccine Compared to Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) Typhoid Vaccine in Healthy Filipino Adults and Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events
研究概览
简要总结
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
- To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.
详细描述
This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.
入排标准
- 年龄范围
- 2 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female individual 2-45 years of age
- •Participants/Parents who have voluntarily given informed consent and/or assent.
- •Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of study
排除标准
- •Participants concomitantly enrolled or scheduled to be enrolled in another trial
- •Acute illness, in particular infectious diseases or fever (axillary temperature > 38°C), with in three days prior to enrollment and vaccination.
- •Known history of allergy to vaccines or other medications
- •Known history of allergy to egg, chiken protein, neomycin and formaldehyde.
- •History of uncontrolled coagulopathy or blood disorders
- •Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- •Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
- •Pregnancy & Lactation (female adults)
- •Female with child-bearing potential during the study period. i.e., sexually active and not practicing effective acceptable contraceptive method
- •Individuals who have previously received any vaccines against typhoid fever
- •Individuals already immunized with any licensed vaccine within 4 weeks prior to enrolment/vaccination (day 0) and expected to receive other licensed vaccines within 60 days following the first dose (day 0), except for tetanus toxoid vaccine
- •Individuals who have a previously ascertained or suspected disease caused by S. typhi.
- •Individuals who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
- •History of alcohol or substance abuse
- •Subject planning to move from the study area before the end of study period
结局指标
主要结局
Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events
时间窗: 4 weeks post first and second vaccination
Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs)
次要结局
- Proportion of participants with sero-conversion(4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide)
- Geometric Mean Titers (GMT)(4 weeks post first and second vaccination)