A randomised, open and controlled clinical study to evaluate the reactogenicity, tolerance and immunogenicity profile of 7C671/1 Heberbiovac HB standard vaccine batch candidate in healthy adult volunteers.

Center for Genetic Engineering and Biotechnology (CIGB).0 个研究点目标入组 246 人开始时间: 2011年5月16日最近更新: 2024年8月19日

研究概览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Prevention

•1) Apparently healthy subjects, both sexes. 2) Age from 18 up to 65 years old. 3) Current contraceptive device use for women on reproductive age or not planning a pregnancy in the forthcoming six month after enrollment in the trial. 4) Signing of the written inform consent act.

•1) History of viral hepatitis type B or previous vaccination against Hepatitis B. 2) Seropositivity for HBsAg (HBsAg+) 3) Underlying immunosuppressive disease, current intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry. 4) Non-controlled Chronic diseases (eg. Arterial hypertension, Diabetes mellitus, renal failure, heart failure, hyper-thiroidism, malignant neoplasia, epilepsy, etc), autoimmune disease (Systemic lupus erithematosus, rheumatoid arthritis, Multiple sclerosis, Type 1 Diabetes Mellitus, etc.) 5) Feverish states (>37.5°C) at the moment of each vaccination visit 6) History of severe allergy (Asthma Grade III or IV, urtycaria, Dermatitis, Bronchitis, etc.). 7) History of thiomersal allergy or allergy to any component of the vaccine. 8) Pregnancy or breastfeeding.

发起方

Center for Genetic Engineering and Biotechnology (CIGB).