A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

Study Overview
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Brief Summary
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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

Official Title
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A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan

Conditions
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Dengue

Intervention / Treatment
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* Biological: TV003
* Biological: Placebo for TV003


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TV003<br>Live Attenuated Virus Vaccine-TetraVax-DV | Biological: TV003<br>* Live attenuated virus vaccine-TetraVax-DV<br>|
| Placebo Comparator: Placebo for TV003<br>Placebo | Biological: Placebo for TV003<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Day 90 after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of TetraVax-DV assessed by response rates | Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates. | 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. | Up to Day 365 after 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 | 
| Determine the number of vaccinees with recoverable dengue virus. |  | Up to Day 15 after vaccination | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue Vaccine