The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with the GSK AS03B adjuvant and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection. This study is being done to evaluate the safety and immune reaction of administering one dose of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine compared to two doses of inactivated vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Upstate Medical University, SUNY
Syracuse, New York, United States
Number of and intensity of solicited local and general adverse events (AEs) during the 7-day follow-up period after each vaccination
Time frame: Day 7 and Day 35
Number of and intensity of unsolicited adverse events (AEs) during the 7-day follow-up period after each vaccination
Time frame: Day 7 and Day 35
Number of serious adverse events (SAEs)
Time frame: Day 35
Number of potential immune-mediated diseases (pIMDs) and medicall attended AEs
Time frame: Day 56
Geometric mean titers (GMTs) of neutralizing antibodies to each DENV serotype
Assessment of neutralizing antibodies against DENV type 1-4 will be performed by a validated microneutralizing antibody assay.
Time frame: Day 56
Number of participants seropositive for each DENV serotype
Seropositive will be determined by 50% reduction in viral infection (MN50)
Time frame: Day 56
Number of participants trivalent and tetravalent seropositive
Seropositive will be determined by 50% reduction in viral infection (MN50)
Time frame: Day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.