RPCEC00000053已完成1 期
Randomized, double-blind, controlled, phase I-II study to determine the safety, reactogenicity and immunogenicity of a single dose of 1-9 x 10E9 CFU of the live attenuated oral cholera lyophilized vaccine obtained from 638 Vibrio cholerae O1 El Tor Ogawa strain, administered by oral route in healthy adult volunteers from both sex.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 40 years（—）
- 性别
- All
入选标准
- •1-Healthy female or male aged 18 to 40 years 2-Free from obvious health problems as established by medical history, clinical examination, laboratory tests and psychometric tests before entering into the study. 3-Written informed consent obtained from the subjects. 4-To approve a written examination in order to ensure the volunteers understanding related to the study (trial) and others elemental knowledge about cholera.
排除标准
- •1-Previous history of immunodeficiency. 2-Cardiovascular, respiratory, renal, hematological, hepatic, gastrointestinal, neurological, endocrine, and psychiatric diseases or reticuloendothelial system disorders detected during the clinical examination or by laboratory tests. 3-History of Allergy to tetracyclines. 4-Previous history of immunization with cholera vaccine or infection with cholera. 5-Administration of immunoglobulins and/or antibiotics within 30 days preceding the treatment. 6-Positive serological test for human HIV-1-2 virus antibody. 7-Positive serological test for human hepatitis B surface antigen, or hepatitis A and C antibodies. 8-Stool cultures positive for an enteric pathogen. 9-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the treatment. Inhaled and topical steroids are allowed. 10-Administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 11-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 12-Do not approve a written examination in order to ensure the volunteers understanding related to the study (trial) and others elemental knowledge about cholera. 13-Pregnancy adverted by women or detected by mean of a rapid B-HCG pregnancy test on urine. Women during the proximity of the menstrual period at the very moment of the admission of the trial were discarded.
研究者
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