Rotavirus Vaccine Produced by Butantan Institute

Rotavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981669
• Other study ID #: 1242/06
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: March 15, 2013
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: March 2013
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rotavirus Infections

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	No

External Links

•   Butantan Institute