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Rotavirus Vaccine Produced by Butantan Institute

This study has been completed.
Information provided by (Responsible Party):
Butantan Institute Identifier:
First received: September 17, 2009
Last updated: March 15, 2013
Last verified: March 2013
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
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

Resource links provided by NLM:

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. ]
    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 ]
    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.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00981669

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

Additional Information:
Responsible Party: Butantan Institute 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

Keywords provided by Butantan Institute:
brazilian pentavalent rotavirus vaccine

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017