Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Solicited and unsolicited adverse reactions
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled phase I clinical trial with dose-escalation of a synthetic vaccine against Streptococcus pyogenes. The active component of this vaccine candidate is a synthetic polypeptide named StreptInCor designed to elicit humoral and cell-mediated immune responses. The vaccine will be formulated with Aluminium hydroxide in three different doses of StreptInCor (50 µg, 100µg, 200 µg). The proposed vaccination schedule is three doses (0, 1, 6 months). The doses will be escalated for the next group after safety review.
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)
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
- •Healthy volunteers, both sex, aging 18 to 45 years;
- •Availability for all procedures during the study period;
- •Provide free informed consent to join the study
排除标准
- •Diagnosis of concomitant infections or diseases that might affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasias, and autoimmune diseases;
- •Previous or current diagnosis or family antecedent of rheumatic fever, chorea, obsessive-compulsive disorder or glomerulonephritis;
- •Previous or current diagnosis of cardiac disease;
- •Severe asma or Chronic obstructive pulmonary disease (COPD);
- •Abnormal neurological clinical assessment, particularly chorea;
- •Use of treatments that might affect the immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use equal or longer than two weeks), or antineoplastic agents;
- •Use of treatments that might affect heart valves in the latest four weeks, including fenfluramine e dexfenfluramine;
- •Kidney failure determined by creatinine clearance lower than 45 ml/min/1,73m²;
- •History of intolerance or allergy to any component of investigational products, including antigen or adjuvant;
- •Presence of abnormalities in heart valves or heart anatomy defined by echocardiogram;
- •Electrocardiogram disturbances;
- •Presence of cross-reactive antibodies against human tissues (heart, kidney, cartilage, brain) in screening tests;
- •Evidence or suspicion of recent infection due to S. pyogenes assessed by clinical symptoms and negative rapid test for Streptococcus;
- •Pregnancy, breastfeeding mother or intention to became pregnant during the study period;
- •Any other condition that might affect the study process according to the investigators.
结局指标
主要结局
Solicited and unsolicited adverse reactions
时间窗: Six months after last dose
Frequency of solicited and unsolicited adverse reactions
Immune response to vaccine
时间窗: Six months after last dose
Rate of seroconversion for vaccine epitopes
次要结局
未报告次要终点