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
Verified date | August 2019 |
Source | Medigen Vaccine Biologics Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Medigen Vaccine Biologics Corp. |
Taiwan,
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. |
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