The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Status:
Completed
Trial end date:
2018-06-07
Target enrollment:
Participant gender:
Summary
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines
work remarkably well in high-income countries, but for unclear reasons they underperform in
low-income countries. A double-blind, randomized control trial will be performed to evaluate
whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can
improve immune responses among infants in Dhaka, Bangladesh.
Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6
and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum
rotavirus-specific IgA responses to determine vaccine immunogenicity.
Phase:
Phase 4
Details
Lead Sponsor:
University of Vermont
Collaborators:
Charles H. Hood Foundation International Centre for Diarrhoeal Disease Research, Bangladesh Thrasher Research Fund