A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
Status:
Completed
Trial end date:
2014-01-10
Target enrollment:
Participant gender:
Summary
A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose
schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare
the immunogenicity of different dose schedules of the vaccine.
Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of
viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then
on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue
neutralizing antibodies in serum were obtained at baseline [during the screening period or on
day of vaccination (Day 0)], then on Days 30, 90 and 120.
The entire duration for each individual subjects participation was approximately 5 months
including recruitment and collection of data for primary outcomes (through Day 120).