RPCEC00000051已完成1 期
Randomized, double-blind, placebo controlled phase Ib-IIb study to evaluate the immunogenicity, safety and reactogenicity of 10E8-10E9 CFU single dose of 638 V. cholerae O1 El Tor Ogawa, oral, live attenuated cholera lyophilized vaccine in presumed-healthy adult female and male volunteers in Mozambique.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
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: Prevention
入排标准
- 年龄范围
- 18 years 至 40 years（—）
- 性别
- All
入选标准
- •1-Presumed-healthy adult male and female volunteers, between 18 to 40 years of age. 2-Written informed consent obtained from the subjects.
排除标准
- •1-Clinical manifestation of immunodeficiency. 2-Acute or chronic diseases adverted by volunteer during clinical examination or detected by mean of laboratory test, including bronchial asthma, cancer, neurological diseases, cardiovascular diseases and convulsions. 3-Previous history of immunization with cholera vaccines. 4-Previous cholera infections adverted by volunteers on the last 3 years. 5-History of acute diarrheas 30 days before the beginning of the trial, or chronic diarrheas. 6-Stool positive cultures for V. cholerae. 7-Optical density two times higher than the mean of optical densities of the 3 negative serum in each ELISA assay for IgG cholera antitoxin serum antibodies, in a 1:200 serum dilution, (O.D. serum sample 1:200 > 2 x mean of negatives controls). Otherwise the presence of vibriocidal antibodies titer = 1280 seven days before immunization. 8-Axilary temperature >= 37.5 °C at the very moment of vaccine/placebo administration. 9-Administration of antibiotics, antimalaric drugs, immunoglobulins or any blood products within 30 days preceding the treatment. 10-Subject under antiretroviral treatment. 11-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. 12-Administration of a vaccine not foreseen by the study protocol 30 days before the treatment. 13-Do not approve a written examination in order to ensure the volunteers understanding related to the study and others elemental knowledge about cholera. 14-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 15-Pregnancy woman or breast-feeding. 16-Alcoholism.
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