A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

Medigen Vaccine Biologics

Status and phase

Completed

Phase 2

Conditions

Dengue

Treatments

Biological: Placebo for TV003

Biological: TV003

Study type

Interventional

Funder types

Industry

Identifiers

NCT03485144

CT-DV-21

Details and patient eligibility

About

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

Enrollment

54 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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