Comparative immunogenicity and reactogenicity of Heberbiovac-HB and three commercial recombinant hepatitis B vaccines in healthy adults”.

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.0 个研究点目标入组 400 人开始时间: 2009年2月27日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

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

•1.Healthy adults from both sexes. 2.Age range: 18 until 45 years old. 3.Current use of contraceptive method for women of fertile age. 4.Written informed consent obtained.

•1.Known history of infection with hepatitis B or present antibodies surface antigen (antiHBs) prior to the inclusion (including pre-vaccination anti-hepatitis B). 2.Positive for surface antigen of hepatitis B (HBsAg +). 3.Underlying immunosuppressive disease, ingestion of current immunosuppressive drugs (including steroids) or in the six months prior to study. 4.People who are decompensated chronic diseases (hypertension, diabetes mellitus, renal failure, heart failure, hyperthyroidism, malignancy, epilepsy, etc.). Or suffer from any autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, diabetes mellitus type 1 , etc). 5.Persons with a severe allergy (asthma grade III or IV, hives, dermatitis, bronchitis, etc). 6.Thiomersal allergy or any of the components of the vaccine. 7.Pregnancy and lactancy.

发起方

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.