Rotavirus Vaccine Produced by Butantan Institute

Phase 1

Completed

• Conditions: Rotavirus Infections
• Interventions: Biological: rotavirus vaccine; Biological: placebo

• Registration Number: NCT00981669
• Lead Sponsor: Butantan Institute

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 Description

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Results First Submitted: 2013-02-04
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-15
• Last Update Submitted: 2013-03-15
• Results First Posted: 2013-04-25
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rotavirus vaccine	rotavirus vaccine	3 doses with 6 weeks interval
placebo	placebo	3 doses with 6 weeks interval

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events.	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.

Secondary Outcome Measures

Name	Time	Method
Anti-rotavirus IgA Level.	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.

Trial Locations

Locations (1)

Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP; 🇧🇷 Sao Paulo, Brazil