The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
54
Live attenuated virus vaccine-TetraVax-DV
Placebo
National Taiwan University Hospital
Taipei, Taiwan
Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination.
Time frame: Up to Day 90 after vaccination
Immunogenicity of TetraVax-DV assessed by response rates
Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates.
Time frame: Up to Day 90 after vaccination
Duration of immunogenicity of TetraVax-DV assessed by PRNT50
Assess the duration of the antibody response by measured serum PRNT50 to each virus type for each subject at study day 180 and day 365 post vaccination.
Time frame: Up to Day 365 after vaccination
Frequency of viremia following vaccination
Time frame: Up to Day 15 after vaccination
Quantity of viremia following vaccination
Time frame: Up to Day 15 after vaccination
Duration of viremia following vaccination
Time frame: Up to Day 15 after vaccination
Determine the number of vaccinees with recoverable dengue virus.
Time frame: Up to Day 15 after vaccination
Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.
Time frame: Up to Day 7 after vaccination.
Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.
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Time frame: Up to Day 21 after vaccination.
Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.
Time frame: Up to Day 365 after vaccination.