Rotavirus Vaccine Produced by Butantan Institute

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

Detailed Description
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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.

Official Title
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Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation

Conditions
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Rotavirus Infections

Intervention / Treatment
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* Biological: rotavirus vaccine
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rotavirus vaccine<br>3 doses with 6 weeks interval | Biological: rotavirus vaccine<br>* 3 doses with 6 weeks interval<br>* Other names: brazilian rotavirus vaccine;|
| Placebo Comparator: placebo<br>3 doses with 6 weeks interval | Biological: placebo<br>* 3 doses with 6 weeks interval<br>* Other names: butantan placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within the first five days post-vaccination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | before each dose (total of doses:3) and after 6 weeks of the third dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, brazilian pentavalent rotavirus vaccine, tolerability, immunogenicity