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.

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