Clinical Trial: Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Brazil's Conjugated Vaccine Project Against Meningococcal C. Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

Brief Summary: 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).

Detailed Summary:

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.

Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Current Primary Outcome: Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans. [ 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 frequency / intensity of adverse events occurring up to 30 days after vaccination.


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults. [ Time Frame: Blood collection 30 days after vaccination ]

30 days after vaccination, blood sampling will be conducted which composes for serological analysis of immunogenicity.


Original Secondary Outcome: Same as current

Information By: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Dates:
Date Received: June 10, 2013
Date Started: May 2014
Date Completion:
Last Updated: September 15, 2015
Last Verified: September 2015