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A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485144
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medigen Vaccine Biologics Corp.

Study Description
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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

Condition or disease Intervention/treatment Phase
Dengue Biological: TV003 Biological: Placebo for TV003 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Vaccines

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Immunogenicity of TetraVax-DV assessed by response rates [ Time Frame: Up to Day 90 after vaccination ]
    Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates.

  2. Duration of immunogenicity of TetraVax-DV assessed by PRNT50 [ Time Frame: Up to Day 365 after vaccination ]
    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.

  3. Frequency of viremia following vaccination [ Time Frame: Up to Day 15 after vaccination ]
  4. Quantity of viremia following vaccination [ Time Frame: Up to Day 15 after vaccination ]
  5. Duration of viremia following vaccination [ Time Frame: Up to Day 15 after vaccination ]
  6. Determine the number of vaccinees with recoverable dengue virus. [ Time Frame: Up to Day 15 after vaccination ]
  7. Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions. [ Time Frame: Up to Day 7 after vaccination. ]
  8. Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions. [ Time Frame: Up to Day 21 after vaccination. ]
  9. Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events. [ Time Frame: Up to Day 365 after vaccination. ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485144


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Medigen Vaccine Biologics Corp.
Investigators
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Principal Investigator: Szu-Min Hsieh, MD National Taiwan University Hospital
More Information
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Responsible Party: Medigen Vaccine Biologics Corp.
ClinicalTrials.gov Identifier: NCT03485144    
Other Study ID Numbers: CT-DV-21
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medigen Vaccine Biologics Corp.:
Dengue Vaccine
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral