Phase I trial to evaluate safety and immunogenicity of Measles and Rubella vaccine (MR) for measles and rubella, in young adults

Bio-Manguinhos/Fiocruz/MS0 个研究点开始时间: 2016年9月12日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Healthy volunteers on screening; male; aged between 18-49 years; availability to provide personal data; availability in strictly follow the research protocol; accept not participate in any other clinical trial during this one and up to 6 months after the end; ability to understand and sign the informed consent term; ability to record symptoms at home; acceptance of HIV testing for HIV, HBV and HCV.

•Serious adverse event due to the study vaccination; acute or chronic disease; use of allergy shots with antigens, up to 14 days prior to study vaccination; immunoglobulin use in the last 12 months prior to vaccination; use of blood products in the 12 months prior to vaccination; use of any type of vaccine 30 days before vaccination; Chronic use of any medication, except for homeopathic and trivial; previous use of immunosuppressant or cytotoxic medication; use of any investigational medication 1 year prior to vaccination; asthma (unstable, that has required urgent care in the last 24 months, or requiring the use of corticosteroids); neurological, cardiovascular, respiratory, hepatic, renal, hematologic, rheumatic or autoimmune - clinically significant; coagulopathies; Seizures before age 2 years; psychiatric illness that hinder adherence to the protocol; Active malignancy; asplenia; HIV, HCV and / or HBV positive; alcohol abuse (CAGE criteria); illicit drugs abuse; congenital or acquired immunodeficiency; allergy vaccine components, such as egg, neomycin and gelatin.

发起方

Bio-Manguinhos/Fiocruz/MS