A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

NCT ID: NCT03485144

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2019-05-10

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

Conditions

Dengue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

TV003

Live Attenuated Virus Vaccine-TetraVax-DV

Group Type: EXPERIMENTAL

TV003

Intervention Type: BIOLOGICAL

Live attenuated virus vaccine-TetraVax-DV

Placebo for TV003

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo for TV003

Intervention Type: BIOLOGICAL

Placebo

Interventions

TV003

Live attenuated virus vaccine-TetraVax-DV

Intervention Type: BIOLOGICAL

Placebo for TV003

Placebo

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medigen Vaccine Biologics Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Szu-Min Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

CT-DV-21

Identifier Type: -

Identifier Source: org_study_id