Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever
Condition: Dengue Fever
MeSH terms: Dengue; Fever
Intervention: TDV - Low Dose; TDV - High Dose; Placebo
Intervention description: TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, and TDV-4: 2 x 10^5 PFU, total virus per dose 2.2 x 10^5 PFU; TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, and TDV-4: 3 x 10^5 PFU, total virus per dose : 4.7 x 10^5 PFU. TDV administered intradermally.; Phosphate Buffered Saline (PBS)
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dengue fever; live attenuated tetravalent dengue vaccine; TDV; Drug therapy

Summary:

      The purpose of this study is to assess the safety of Takeda's Tetravalent Dengue Vaccine
      Candidate (TDV) (previously DENVax) in healthy adults when given as either a subcutaneous
      (SC) or intradermal (ID) injection at two dose levels (low and high). The vaccine will be
      given as two doses 90 days apart. Safety assessments include injection site evaluation and
      adverse events. The immune response generated after vaccination will be assessed up to 9
      months after the first vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male or female aged 18 to 45 years, inclusive, at time of screening.

          -  Is in good health as determined by medical history, physical examination, and clinical
             safety laboratory examinations.

          -  Has body mass index (BMI) in the range 18-27 kilogram per square meter (kg/m^2).

          -  Has negative serology for Human Immunodeficiency Virus (HIV), Hepatitis C antibody,
             and Hepatitis B surface antigen.

          -  Females of child bearing potential must have a negative urine pregnancy test result
             during screening and a negative urine pregnancy test immediately prior to vaccination
             and be willing to use oral, implantable, transdermal or injectable contraceptives or
             another reliable means of contraception approved by the Investigator (intrauterine
             device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the
             sexual partner or a sterile sexual partner, or abstinence) from screening until after
             the last blood sample (at Day 270).

          -  Is willing and able to give written informed consent to participate.

          -  Is willing and able to communicate with the Investigator and understand the
             requirements of the study.

        Exclusion Criteria:

          -  Has any condition which would limit the participant's ability to complete the study.

          -  Clinically significant hematological, renal, hepatic, pulmonary, central nervous
             system, cardiovascular or gastrointestinal disorders.

          -  Has abnormal electrocardiogram (ECG).

          -  Has febrile illness (temperature greater than or equal to (>=) 38 degree Celsius (°C)
             or 100.4 degree Fahrenheit (°F) or moderate or severe acute illness or infection
             within three days of vaccination.

          -  Diabetes mellitus.

          -  Has allergy to penicillin, neomycin, streptomycin or gentamicin.

          -  Hypersensitivity to any vaccine.

          -  Seropositivity to any of the four dengue serotypes (TDV-1, TDV-2, TDV-3 or TDV-4),
             yellow fever (YF) virus or West Nile (WN) virus.

          -  Has previous vaccination (in a clinical trial or with an approved product) against
             flaviviruses including dengue, YF or WN.

          -  Has planned vaccination against YF throughout the duration of this study.

          -  Has receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

          -  Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in
             this study.

          -  Travel to dengue-endemic areas in the two months prior to study start or planned
             travel to dengue-endemic areas during the study period, including low altitude regions
             of Colombia where dengue is endemic.

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
             prior to the first vaccination, or long- term (at least 2 weeks within the previous 3
             months) systemic corticosteroids therapy (at a dose of at least 0.5 milligram per
             kilogram per day [mg/kg/day]) prior to the first vaccination.

          -  Has a history of recurring migraines or on prescription medication for treatment of
             recurring headaches or migraines.

          -  Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or
             antihistamines for the 3 days immediately prior to each vaccination.

          -  Use of prescription or over the counter medications 7 days before the first
             vaccination (Day 0), excluding contraceptives and painkillers containing NSAIDs or
             acetaminophen, cold remedies, hormone replacement and antihistamines.

          -  Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids.

          -  Receipt of any other investigational product or participation in any other clinical
             trial in the month before the first vaccination (Day 0) or during the conduct of this
             study.

          -  Receipt of blood products or immunoglobulins 8 weeks before the first vaccination (Day
             0) or planned use during the study period.

          -  Donation of blood 6 weeks before the first vaccination (Day 0) or at any time during
             the study.

          -  Females who are pregnant or lactating.