Dengue
Conditions
Keywords
Dengue Vaccine
Brief summary
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
Interventions
BIOLOGICALTV003
Live attenuated virus vaccine-TetraVax-DV
BIOLOGICALPlacebo for TV003
Placebo
Sponsors
Medigen Vaccine Biologics Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult male or female between 20 and 70 years of age * Good general health as determined by physical examination, laboratory screening, and review of medical history * Available for the duration of the study * Willingness to sign the informed consent document * Female of childbearing potential willing to use effective contraception for the duration of the trial
Exclusion criteria
* Females currently pregnant, as determined by positive β- human choriogonadotropin (HCG) test, and/or breast-feeding. * Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies * Behavioral, cognitive, or psychiatric disease * Below lower limit of normal for absolute neutrophil count * Any significant alcohol or drug abuse in the past 12 months * History of a severe allergic reaction or anaphylaxis * Self-reported systemic hypersensitivity to any of the vaccine components * Severe asthma * Known HIV, Hepatitis B or hepatitis C * Any known immunodeficiency syndrome * Use of anticoagulant medications * Receive chronic administration of immunosuppressant drugs within 6 months prior to the administration of the study vaccine * Use of any investigational product within 30 days before study vaccination or at any time during the study * Asplenia * Receive administration of immunoglobulins and/or any blood products within 12 months preceding the administration of the study vaccine or at any time during the study * Fever or suspected fever within 72 hours prior to vaccination or tympanic temperature greater than 38°C on the day of vaccination * Receive administration of any licensed live attenuated vaccines within 30 days preceding the administration of the study vaccine and ending 30 days after * Receive administration of any licensed inactivated vaccines within 14 days preceding the administration of the study vaccine and ending 14 days after * Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50) | Up to Day 90 after vaccination | Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of immunogenicity of TetraVax-DV assessed by PRNT50 | Up to Day 365 after vaccination | 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. |
| Frequency of viremia following vaccination | Up to Day 15 after vaccination | — |
| Quantity of viremia following vaccination | Up to Day 15 after vaccination | — |
| Duration of viremia following vaccination | Up to Day 15 after vaccination | — |
| Immunogenicity of TetraVax-DV assessed by response rates | Up to Day 90 after vaccination | Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates. |
| Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions. | Up to Day 7 after vaccination. | — |
| Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions. | Up to Day 21 after vaccination. | — |
| Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events. | Up to Day 365 after vaccination. | — |
| Determine the number of vaccinees with recoverable dengue virus. | Up to Day 15 after vaccination | — |
Countries
Taiwan
Outcome results
None listed