Back to resultsRotavirus Vaccine Produced by Butantan Institute
Primary Purpose
Rotavirus Infections
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
rotavirus vaccine
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Rotavirus Infections focused on measuring brazilian pentavalent rotavirus vaccine, safety, tolerability, immunogenicity
Eligibility 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
Sites / Locations
- Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rotavirus vaccine
placebo
Arm Description
3 doses with 6 weeks interval
3 doses with 6 weeks interval
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00981669
Brief Title
Rotavirus Vaccine Produced by Butantan Institute
Official Title
Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butantan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Infections
Keywords
brazilian pentavalent rotavirus vaccine, safety, tolerability, immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rotavirus vaccine
Arm Type
Experimental
Arm Description
3 doses with 6 weeks interval
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
3 doses with 6 weeks interval
Intervention Type
Biological
Intervention Name(s)
rotavirus vaccine
Other Intervention Name(s)
brazilian rotavirus vaccine
Intervention Description
3 doses with 6 weeks interval
Intervention Type
Biological
Intervention Name(s)
placebo
Other Intervention Name(s)
butantan placebo
Intervention Description
3 doses with 6 weeks interval
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events.
Description
Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.
Time Frame
Within the first five days post-vaccination.
Secondary Outcome Measure Information:
Title
Anti-rotavirus IgA Level.
Description
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.
Time Frame
before each dose (total of doses:3) and after 6 weeks of the third dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander R Precioso, MD,PhD
Organizational Affiliation
Butantan Institute
Official's Role
Study Director
Facility Information:
Facility Name
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19551286
Citation
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.
Results Reference
background
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Rotavirus Vaccine Produced by Butantan Institute
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