Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).
Study design - This is a clinical study Phase I, randomized, double blind with 60 individuals. 30 individuals will receive the experimental vaccine by Bio-Manguinhos/Fiocruz and 30 individuals will receive a meningococcal C conjugated vaccine used in the National Immunization Program. Location of Study - Clinical Trials Unit for Immunobiology by Bio-Manguinhos/Fiocruz. Primary objective - Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans. Secondary objective - To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults. specific objectives 1. To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination. 2. To evaluate the seroconversion defined as pre-immunization serum nonreactive (negative) and post-immunization reactor (positive) antigens, with getting titles 8 (rabbit complement) to the target strain used in the test of bactericidal power of the sera from immunized volunteers, a 4-fold increase in titers following vaccination compared to pre-vaccination and antibody titers after immunization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.
The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.
Unidade de Ensaios Clínicos para Imunobiológicos
Rio de Janeiro, Rio de janeiro/RJ, Brazil
Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans.
To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination.
Time frame: Adverse events post vaccination will be evaluated on days 1,3, 10 and 15 by phone call and on days 2, 7 and 30 at the research center
To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults.
30 days after vaccination, blood sampling will be conducted which composes for serological analysis of immunogenicity.
Time frame: Blood collection 30 days after vaccination
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