Rotavirus Vaccine Produced by Butantan Institute

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT00981669
First received: September 17, 2009
Last updated: March 15, 2013
Last verified: March 2013

September 17, 2009
March 15, 2013
March 2009
March 2010   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events. [ Time Frame: Within the first five days post-vaccination. ] [ Designated as safety issue: Yes ]
Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.
Titers of anti-rotavirus IgA and the presence of neutralizing antibodies anti-totavirus. Seroconversion will be considered as a 4 fold increase in IgA titers. Proportion of seroconverters in both groups will be compared. [ Time Frame: before each dose (total of doses:3) and after 6 weeks of the third dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00981669 on ClinicalTrials.gov Archive Site
Anti-rotavirus IgA Level. [ Time Frame: before each dose (total of doses:3) and after 6 weeks of the third dose ] [ Designated as safety issue: No ]
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.
Safety and tolerability will be evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes. Viral shedding in feces will be evaluated after the first and third dose of the vaccine as well. [ Time Frame: During the interval of the doses untill 6 weeks after the third dose. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Rotavirus Vaccine Produced by Butantan Institute
Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Rotavirus Infections
  • Biological: rotavirus vaccine
    3 doses with 6 weeks interval
    Other Name: brazilian rotavirus vaccine
  • Biological: placebo
    3 doses with 6 weeks interval
    Other Name: butantan placebo
  • Experimental: rotavirus vaccine
    3 doses with 6 weeks interval
    Intervention: Biological: rotavirus vaccine
  • Placebo Comparator: placebo
    3 doses with 6 weeks interval
    Intervention: Biological: placebo
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2010
March 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00981669
1242/06
Yes
Butantan Institute
Butantan Institute
Not Provided
Study Director: Alexander R Precioso, MD,PhD Butantan Institute
Butantan Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP