Rotavirus Vaccine Produced by Butantan Institute

Overview

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

Full Title of Study: “Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I – Safety, Tolerability and Immunogenicity Evaluation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2010

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.

Interventions

  • Biological: rotavirus vaccine
    • 3 doses with 6 weeks interval
  • Biological: placebo
    • 3 doses with 6 weeks interval

Arms, Groups and Cohorts

  • Experimental: rotavirus vaccine
    • 3 doses with 6 weeks interval
  • Placebo Comparator: placebo
    • 3 doses with 6 weeks interval

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Butantan Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexander R Precioso, MD,PhD, Study Director, Butantan Institute

References

Higashi HG, Luna E, Precioso AR, Vilela M, Kubrusly FS, Dias WO, Raw I. Acellular and "low" pertussis vaccines: adverse events and the role of mutations. Rev Inst Med Trop Sao Paulo. 2009 May-Jun;51(3):131-4. doi: 10.1590/s0036-46652009000300002.

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