Clinical trial NCT03485144: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue
Keywords: Dengue Vaccine
Lead sponsor: Medigen Vaccine Biologics Corp.
Sponsor class: INDUSTRY
First posted: 2018-04-02
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50)
timeFrame: Up to Day 90 after vaccination
Secondary outcomes:
measure: Immunogenicity of TetraVax-DV assessed by response rates
timeFrame: Up to Day 90 after vaccination
measure: Duration of immunogenicity of TetraVax-DV assessed by PRNT50
timeFrame: Up to Day 365 after vaccination
measure: Frequency of viremia following vaccination
timeFrame: Up to Day 15 after vaccination
measure: Quantity of viremia following vaccination
timeFrame: Up to Day 15 after vaccination
measure: Duration of viremia following vaccination
timeFrame: Up to Day 15 after vaccination
measure: Determine the number of vaccinees with recoverable dengue virus.
timeFrame: Up to Day 15 after vaccination
measure: Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions.
timeFrame: Up to Day 7 after vaccination.
measure: Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions.
timeFrame: Up to Day 21 after vaccination.
measure: Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events.
timeFrame: Up to Day 365 after vaccination.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Szu-Min Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: