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Completed

NCT Number: NCT00981669

Rotavirus Vaccine Produced by Butantan Institute

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

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Key information

Conditions

Rotavirus Infections Infections RNA Virus Infections Reoviridae Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotavirus vaccine

Biological

3 doses with 6 weeks interval

Other names: brazilian rotavirus vaccine

Placebo

Biological

3 doses with 6 weeks interval

Other names: butantan placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Butantan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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