A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

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

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 Overview

• Status: Completed
• Conditions: Dengue
• Intervention / Treatment: Biological: TV003; Biological: Placebo for TV003

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TV003; Live Attenuated Virus Vaccine-TetraVax-DV	Biological: TV003; Live attenuated virus vaccine-TetraVax-DV
PLACEBO_COMPARATOR: Placebo for TV003; Placebo	Biological: Placebo for TV003; Placebo

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Medigen Vaccine Biologics Corp.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2017
• Primary Completion (ACTUAL): May 10, 2019
• Study Completion (ACTUAL): May 10, 2019

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (ACTUAL): April 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Dengue Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue
• Other Study ID Numbers: CT-DV-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No