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Alternative hepatitis B vaccination schedules in homeless men in Goiás
RBR-6ffdnxPhase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2018
- Countries
- 1
- Sponsor
- Faculdade de Enfermagem da Universidade Federal de Goiás
- Modality
- Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- Conditions
- hepatitis B (HBV)
01
Overview
Phase 2, randomised, open-label trial of hepatitis b vaccine (recombinant) in hepatitis B (HBV) (2 arms), sponsored by Faculdade de Enfermagem da Universidade Federal de Goiás. Primary endpoints: Immunogenicity after vaccination and Seroprotection rate. Started Mar 2018; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Ultra-accelerated GeneVac-B schedule
Three-dose intramuscular hepatitis B vaccine schedule at days 0, 7, and 21.
Accelerated GeneVac-B schedule
Three-dose intramuscular hepatitis B vaccine schedule at 0, 1, and 2 months.
03
Who it enrols
Adult homeless men aged 18 years or older who have lived on the street for at least 30 days, are present at the data collection site for no more than 30 consecutive days, and are susceptible to hepatitis B virus infection.
04
Endpoints
Primary
Immunogenicity after vaccination
Seroprotection rate
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