A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
Condition: Healthy
MeSH terms: Dengue
Intervention: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); TDV New Formulation; Placebo; New Formulation Placebo
Intervention description: TDV subcutaneous injection; TDV New Formulation subcutaneous injection; Placebo subcutaneous injection; New Formulation placebo subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety and immunogenicity of dengue vaccine

Summary:

      A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose
      schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare
      the immunogenicity of different dose schedules of the vaccine.

      Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of
      viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then
      on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue
      neutralizing antibodies in serum were obtained at baseline [during the screening period or on
      day of vaccination (Day 0)], then on Days 30, 90 and 120.

      The entire duration for each individual subjects participation was approximately 5 months
      including recruitment and collection of data for primary outcomes (through Day 120).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 18 years and ≤ 45 years old at time of screening

          2. In good health as determined by medical history, physical examination including height
             and weight

          3. Normal clinical safety laboratory examinations [Sodium (Na), Potassium (K), Glucose,
             Blood Urea Nitrogen (BUN), creatinine, Alanine aminotransferase (ALT), Aspartate
             aminotransferase (AST), total bilirubin, White Blood Cell (WBC), neutrophil count,
             hemoglobin, platelets, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and
             urinalysis (by dipstick)].

          4. Weight: Body Mass Index (BMI) ≤32

          5. Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and
             Hepatitis B surface antigen

        Exclusion Criteria:

          1. Any condition which would limit the subject's ability to complete the study in the
             opinion of the Investigator

          2. Clinically significant ECG findings

          3. History of any significant dermatologic disease in the last 6 months,

          4. History of diabetes mellitus

          5. History of recurring headaches or migraines (more frequent than once per week) or on
             prescription medication for treatment of recurring headaches or migraines

          6. Hypersensitivity to any vaccine

          7. Receipt of any vaccine in the 4 weeks preceding the first vaccination

          8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in
             this study

          9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)

         10. Previous vaccination (in a clinical trial or with an approved product) against
             flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)

         11. Seropositivity to dengue or West Nile (WN) virus

         12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months

         13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at
             least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or
             within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed

         14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or
             antihistamines for the 3 days immediately prior to each vaccination

         15. Use of any prescription or over the counter medications (besides those specifically
             mentioned above or those required for medical management of concurrent diseases) 7
             days before the first vaccination (Day 0)

         16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids

         17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the
             dose on day 90

         18. Females who are pregnant or lactating