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Rotavirus Vaccine Produced by Butantan Institute

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00981669
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : April 25, 2013
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
Butantan Institute

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

Condition or disease Intervention/treatment Phase
Rotavirus Infections Biological: rotavirus vaccine Biological: placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981669


Locations
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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
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Study Director: Alexander R Precioso, MD,PhD Butantan Institute
More Information
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Additional Information:

Publications:

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Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT00981669    
Other Study ID Numbers: 1242/06
First Posted: September 22, 2009    Key Record Dates
Results First Posted: April 25, 2013
Last Update Posted: April 25, 2013
Last Verified: March 2013
Keywords provided by Butantan Institute:
brazilian pentavalent rotavirus vaccine
safety
tolerability
immunogenicity
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
 Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs