Measles and Rubella
Conditions
Interventions
The study will count on 30 subjects vaccined. Two doses of a single batch of measles and rubella vaccine, produced by Bio-Manguinhos/Fiocruz will be administered subcutaneously. The interval between d
Biological/vaccine
Y59.9
Sponsors
Bio-Manguinhos/Fiocruz/MS
Bio-Manguinhos/Fiocruz/MS
Eligibility
Sex/Gender
Male
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is a study to acess vaccine safety, reported in forms and diaries of adverse events distributed to subjects and occurred within 30 days after each dose of vaccine, through frequency tables and intensity of adverse events - local, systemic and not expected.;Among the 30 vaccinated subjects, 12 (40%) had at least one adverse event requested after the first dose and 6 (20%) after the second dose. No serious adverse events were recorded. Of the 18 laboratory results to increase postvaccination degree , compared to pre- vaccination , 4 were classified as grade 3 and one as grade 4 without clinical significance. | — |
Secondary
| Measure | Time frame |
|---|---|
| The immunogenicity of the vaccine under study will be analysed by the geometric mean titers of antibodies pre and post vaccination evaluation that will be obtained by enzyme-linked immunosorbent assay (ELISA) with blood samples from the participants before (baseline) and after each dose of vaccine administered .;The geometric mean titers (GMT) for measles and rubella increased after the 1st and 2nd doses , compared to pre-vaccination titers. The ratio of measles TMG post/pre 1st dose was about 3 times, and rubella, 1.5. The ratio GMT measles post 2nd dose/pre 1st dose was 3.1 and 1.5 rubella again. | — |
Countries
Brazil
Contacts
Public ContactJosé Cerbino Neto
Instituto Nacional de Infectologia Evandro Chagas
Outcome results
None listed