Clinical Trial: Rotavirus Vaccine Produced by Butantan Institute

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

Official Title: Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation

Brief Summary: The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.

Detailed Summary: The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.
Sponsor: Butantan Institute

Current Primary Outcome: Number of Participants With Adverse Events. [ Time Frame: Within the first five days post-vaccination. ]

Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.


Original Primary Outcome: Titers of anti-rotavirus IgA and the presence of neutralizing antibodies anti-totavirus. Seroconversion will be considered as a 4 fold increase in IgA titers. Proportion of seroconverters in both groups will be compared. [ Time Frame: before each dose (total of doses:3) and after 6 weeks of the third dose ]

Current Secondary Outcome: Anti-rotavirus IgA Level. [ Time Frame: before each dose (total of doses:3) and after 6 weeks of the third dose ]

It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.


Original Secondary Outcome: Safety and tolerability will be evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes. Viral shedding in feces will be evaluated after the first and third dose of the vaccine as well. [ Time Frame: During the interval of the doses untill 6 weeks after the third dose. ]

Information By: Butantan Institute

Dates:
Date Received: September 17, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 15, 2013
Last Verified: March 2013