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

Medigen Vaccine Biologics Corp.1 site in 1 country54 target enrollmentDecember 12, 2017

ConditionsDengue

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Dengue
Sponsor: Medigen Vaccine Biologics Corp.
Enrollment: 54
Locations: 1
Primary Endpoint: Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 12, 2017

End Date

May 10, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medigen Vaccine Biologics Corp.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)

Time Frame: 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 Outcomes

Immunogenicity of TetraVax-DV assessed by response rates(Up to Day 90 after vaccination)
Duration of immunogenicity of TetraVax-DV assessed by PRNT50(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.)