Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: TDV Liquid Formulation 1; TDV Liquid Formulation 2; TDV IDT Lyophilized; Placebo
Intervention description: TDV Liquid Formulation 1 for subcutaneous injection; TDV Liquid Formulation 2 for subcutaneous injection; TDV Lyophilized Formulation for subcutaneous injection; TDV liquid formulation placebo-matching solution for subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1002.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the equivalence of the lyophilized formulation of
      Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of
      TDV.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is aged 18 to 49 years, at the time of enrollment inclusive.

          2. Individuals who are in good health at the time of entry into the trial as determined
             by medical history, physical examination (including vital signs) and clinical judgment
             of the investigator.

          3. Signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any trial procedures, after the nature of the
             trial has been explained according to local regulatory requirements.

          4. Individuals who can comply with trial procedures and are available for the duration of
             follow-up.

        Exclusion Criteria:

          1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or
             infection at the time of enrollment. Trial entry should be delayed until the illness
             has improved.

          2. History or any illness that, in the opinion of the investigator, might interfere with
             the results of the trial or pose additional risk to the participants due to
             participation in the trial, including but not limited to: a. Known hypersensitivity or
             allergy to any of the vaccine components; b. Individuals with history of substance or
             alcohol abuse within the past 6 months; c. Female participants who are pregnant or
             breastfeeding; d. Individuals with any serious chronic or progressive disease
             according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes,
             cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré
             syndrome); e. Known or suspected impairment/alteration of immune function, including:
             i. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2
             mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of
             inhaled, intranasal, or topical corticosteroids is allowed); Receipt of parenteral
             steroids (equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day
             prednisone ≥ 2 weeks) within 60 days prior to Day 1; iii. Administration of
             immunoglobulins and/or any blood products within the three months preceding the first
             administration of the investigational vaccine or planned administration during the
             trial; iv. Receipt of immunostimulants within 60 days prior to Day 1; v.
             Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             6 months preceding (first) vaccination; vi. human immunodeficiency virus (HIV)
             infection or HIV-related disease; vii. Genetic immunodeficiency.

          3. Individuals who received any other vaccines within 14 days (for inactivated vaccines)
             or 28 days (for live vaccines) prior to enrollment in this trial or who are planning
             to receive any vaccine within 28 days of investigational vaccine administration.

          4. Individuals participating in any clinical trial with another investigational product
             30 days prior to first trial visit or intent to participate in another clinical trial
             at any time during the conduct of this trial.

          5. Individuals who are first degree relatives of individuals involved in trial conduct.

          6. If female of childbearing potential, sexually active, and has not used any of the
             acceptable contraceptive methods for at least 2 months prior to trial entry: a. Of
             childbearing potential is defined as status post onset of menarche and not meeting any
             of the following conditions: menopausal (for at least 2 years), bilateral tubal
             ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year
             previously) or hysterectomy; b. Acceptable birth control methods are defined as one or
             more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal
             patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with
             spermicide) each and every time during intercourse; iii. Intrauterine device (IUD);
             iv. Monogamous relationship with vasectomized partner. Partner must have been
             vasectomized for at least six months prior to the participants' trial entry.

          7. If female of childbearing potential, sexually active and refuses to use an acceptable
             contraceptive method through to 6 weeks after the last dose of investigational
             vaccine.

          8. Individuals with body mass index (BMI) greater than or equal to 35.

          9. Participants who received previous vaccination (in a clinical trial or with an
             approved product) against flaviviruses including dengue, yellow fever (YF), West Nile
             (WN), Japanese Encephalitis (JE), and St. Louis encephalitis.

         10. Documented or suspected disease caused by dengue, JE, WN, YF virus, and/or St. Louis
             encephalitis.

         11. History of travel to dengue endemic areas including the Caribbean, Mexico, Central
             America, South America or Southeast Asia during the 6 months prior to screening or
             planned travel to a dengue endemic area during the study period.

         12. Clinically significant abnormality in the screening laboratory tests as judged by the
             Investigator.

         13. History of recurring headaches or migraines (more frequent than once per week) or on
             prescription medication for treatment of recurring headaches or migraines.

         14. Blood tests positive for antibodies to HIV-1/2, Hepatitis C and Hepatitis B surface
             antigen.