NCT03485144

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

March 2, 2018

Last Update Submit

August 12, 2019

Conditions

Dengue

Keywords

Dengue Vaccine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

TV003

EXPERIMENTAL

Live Attenuated Virus Vaccine-TetraVax-DV

Biological: TV003

Placebo for TV003

PLACEBO COMPARATOR

Placebo

Biological: Placebo for TV003

Interventions

TV003BIOLOGICAL

Live attenuated virus vaccine-TetraVax-DV

TV003
Placebo for TV003BIOLOGICAL

Placebo

Placebo for TV003

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Szu-Min Hsieh, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

April 2, 2018

Study Start

December 12, 2017

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

TW(1)