Rotavirus Vaccine Produced by Butantan Institute

Butantan Institute

Status and phase: Completed; Phase 1

Conditions: Rotavirus Infections

Treatments: Biological: placebo; Biological: rotavirus vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00981669

1242/06

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

rotavirus vaccine

Experimental group

Description:

3 doses with 6 weeks interval

Treatment:

Biological: rotavirus vaccine

placebo

Placebo Comparator group

Description:

3 doses with 6 weeks interval

Treatment:

Biological: placebo