Title
Rotavirus Vaccine Produced by Butantan Institute
Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
Phase
Phase 1Lead Sponsor
Butantan InstituteStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Rotavirus InfectionsIntervention/Treatment
human rotavirus, live attenuated ...Study Participants
80The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
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.
3 doses with 6 weeks interval
3 doses with 6 weeks interval
Inclusion Criteria: Male healthy Age ≥18-40 years Not taking immunosuppressive drugs No clinical history of gastrointestinal diseases or surgeries No history of cardiac, neurologic, immunologic or endocrine diseases Normal eligibility laboratory tests To be willing to participate and sign the informed consent form No participation in another clinical trial in the past 6 months Exclusion Criteria: Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
| Event Type | Organ System | Event Term | Rotavirus Vaccine | Placebo |
|---|
Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.
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.
