A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Trial to Determine the Safety and Immunogenicity of Typhax Delivered IM
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Anti-Vi IgG antibody seroconversion and geometric mean antibody titers
研究概览
简要总结
This was a randomized, double-blind, ascending dose study conducted at a single clinical research center.
详细描述
Healthy adult subjects aged 18 to 55 years were assigned to 3 ascending dose cohorts of Typhax (0.5, 2.5 or 10 mcg Vi antigen). Groups of 15 subjects in each dose cohort were randomized to receive Typhax, Typhim Vi (25 mcg Vi antigen) or placebo (saline) in a ratio of 3:1:1, respectively. Typhax and placebo (saline) was administered as two dose regimen (Days 0 and 28), and Typhim Vi was given as a single dose (Day 0) with matching placebo on Day 28. All doses were administered by a unblinded third-party as 0.5 mL by intramuscular (IM) injection. Safety and reactogenicity endpoints was assessed at 14 and 28 days after the first Typhax vaccination and 14 days after the second vaccination. Immunogenicity was assessed using an enzyme-linked immunosorbent assay (ELISA) to measure anti-Vi antibody serum titers on days 0, 14, 28, 42 and 180. A positive immune response (seroconversion) by ELISA is defined as at least a 4-fold increase over baseline in the Vi-specific ELISA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Study vaccine will be administered by an unblinded staff member at the clinic
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men or women who are not pregnant or planning to become pregnant during study duration aged 18 to 55 years.
- •Clinical laboratory parameters within normal laboratory limits or not found to be clinically significant by the PI
排除标准
- •Relevant history of physical or psychiatric illness or medical disorder that required treatment.
- •Known or suspected hypersensitivity to investigational product
- •Immunocompromised subjects
- •Previous Typhoid vaccination or elevated anti-Vi antibodies at screening
- •Known history of Typhoid infection in the previous 6 months
- •Positive HIV, HBsAg, or HCV screen
- •Any other condition or abnormality that, in the opinion of the Investigator, may compromise the safety of the patients
结局指标
主要结局
Anti-Vi IgG antibody seroconversion and geometric mean antibody titers
时间窗: Day 0 - Day 180.
The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 180.
Number of participants reporting adverse events following vaccination with Typhax
时间窗: Days 0 up to Day 210
Adverse events are assessed at study visits by PI for seriousness, relationship to investigational product , severity and other possible etiologies
Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Typhax
时间窗: Days 0 up to Day 56 (= 28 Days post second vaccination)
Solicited Injection Site reactions: Pain, Tenderness, Erythema, Induration; Solicited Systemic Reactions Fever, Headache, Joint Pain, Joint Swelling, Fatigue, Myalgia, Nausea, Vomiting, Diarrhea
次要结局
- Vi-specific B-cell ELISPOT responses(Days 0 through 38)