A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

Dengue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485144
• Other study ID #: CT-DV-21
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2017
• Est. completion date: May 10, 2019

Study information

• Verified date: August 2019
• Source: Medigen Vaccine Biologics Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 ß- 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

Related Conditions & MeSH terms

• Dengue

Intervention

Biological:
• TV003
Live attenuated virus vaccine-TetraVax-DV
• Placebo for TV003
Placebo

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Medigen Vaccine Biologics Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunogenicity of TetraVax-DV assessed by response rates	Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates.	Up to Day 90 after vaccination
Secondary	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
Secondary	Frequency of viremia following vaccination		Up to Day 15 after vaccination
Secondary	Quantity of viremia following vaccination		Up to Day 15 after vaccination
Secondary	Duration of viremia following vaccination		Up to Day 15 after vaccination
Secondary	Determine the number of vaccinees with recoverable dengue virus.		Up to Day 15 after vaccination
Secondary	Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.		Up to Day 7 after vaccination.
Secondary	Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.		Up to Day 21 after vaccination.
Secondary	Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.		Up to Day 365 after vaccination.