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Rotavirus Vaccine Produced by Butantan Institute

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT00981669
First received: September 17, 2009
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Rotavirus Infections
 Biological: rotavirus vaccine
Biological: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation

Resource links provided by NLM:

Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by Butantan Institute:

Primary Outcome Measures:
  • Number of Participants With Adverse Events. [ Time Frame: Within the first five days post-vaccination. ] [ Designated as safety issue: Yes ]
    Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.


Secondary Outcome Measures:
  • Anti-rotavirus IgA Level. [ Time Frame: before each dose (total of doses:3) and after 6 weeks of the third dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 80
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rotavirus vaccine
3 doses with 6 weeks interval
 Biological: rotavirus vaccine
3 doses with 6 weeks interval
Other Name: brazilian rotavirus vaccine
Placebo Comparator: placebo
3 doses with 6 weeks interval
 Biological: placebo
3 doses with 6 weeks interval
Other Name: butantan placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981669

Locations
Brazil
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
Butantan Institute
Investigators
Study Director: Alexander R Precioso, MD,PhD Butantan Institute
  More Information

Additional Information:
Butantan Institute  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT00981669     History of Changes
Other Study ID Numbers: 1242/06
Study First Received: September 17, 2009
Results First Received: February 4, 2013
Last Updated: March 15, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Butantan Institute:
brazilian pentavalent rotavirus vaccine
safety
tolerability
immunogenicity

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013