Back to resultsA Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan
Primary Purpose
Dengue
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
TV003
Placebo for TV003
Sponsored by
About this trial
This is an interventional prevention trial for Dengue focused on measuring Dengue Vaccine
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
- 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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TV003
Placebo for TV003
Arm Description
Live Attenuated Virus Vaccine-TetraVax-DV
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Immunogenicity of TetraVax-DV assessed by response rates
Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates.
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.
Frequency of viremia following vaccination
Quantity of viremia following vaccination
Duration of viremia following vaccination
Determine the number of vaccinees with recoverable dengue virus.
Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.
Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.
Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.
Full Information
NCT ID
NCT03485144
First Posted
March 2, 2018
Last Updated
August 12, 2019
Sponsor
Medigen Vaccine Biologics Corp.
1. Study Identification
Unique Protocol Identification Number
NCT03485144
Brief Title
A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan
Official Title
A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medigen Vaccine Biologics Corp.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
Dengue Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TV003
Arm Type
Experimental
Arm Description
Live Attenuated Virus Vaccine-TetraVax-DV
Arm Title
Placebo for TV003
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
TV003
Intervention Description
Live attenuated virus vaccine-TetraVax-DV
Intervention Type
Biological
Intervention Name(s)
Placebo for TV003
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
Description
Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination.
Time Frame
Up to Day 90 after vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity of TetraVax-DV assessed by response rates
Description
Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates.
Time Frame
Up to Day 90 after vaccination
Title
Duration of immunogenicity of TetraVax-DV assessed by PRNT50
Description
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.
Time Frame
Up to Day 365 after vaccination
Title
Frequency of viremia following vaccination
Time Frame
Up to Day 15 after vaccination
Title
Quantity of viremia following vaccination
Time Frame
Up to Day 15 after vaccination
Title
Duration of viremia following vaccination
Time Frame
Up to Day 15 after vaccination
Title
Determine the number of vaccinees with recoverable dengue virus.
Time Frame
Up to Day 15 after vaccination
Title
Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.
Time Frame
Up to Day 7 after vaccination.
Title
Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.
Time Frame
Up to Day 21 after vaccination.
Title
Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.
Time Frame
Up to Day 365 after vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szu-Min Hsieh, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan
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