A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: 4 µg TDENV-PIV with Alum adjuvant; 1 µg TDENV-PIV with AS03B1 adjuvant; Phosphate buffered saline; 1 µg TDENV-PIV with Alum adjuvant; 1 µg TDENV-PIV with AS01E1 adjuvant
Intervention MeSH terms: Aluminum Hydroxide; Aluminum sulfate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Dengue fever; Dengue Hemorrhagic Fever; Flavivirus

Summary:

      The study is designed to afford a safety and immunogenicity assessment of three Tetravalent
      Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.)

          -  A male or female between 18 and 39 years of age (inclusive) at the time of consent

          -  Written informed consent obtained from the subject

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study

          -  Female subjects of non-childbearing potential (non-childbearing potential is defined
             as having either a current tubal ligation at least three months prior to enrollment,
             hysterectomy, ovariectomy, or is post-menopause). See Definition of Terms for adequate
             contraception.

          -  Female subjects of childbearing potential may be enrolled in the study, if the subject
             has:

               -  Practiced adequate contraception for 30 days prior to vaccination, and

               -  A negative urine pregnancy test on the day of vaccination, and

               -  Agreed to continue adequate contraception until two months after completion of
                  the vaccination series

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines/placebo during the period starting 30 days preceding the first dose of
             study vaccine/placebo and/or planned use during the study period

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs during the period starting 180 days prior to the first
             vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or
             equivalent; inhaled and topical steroids are allowed)

          -  Planned administration or administration of a vaccine/product not foreseen by the
             study protocol during the period starting 30 days prior to the first dose of
             vaccine/placebo until after the visit at Day 56 (if influenza activity warrants
             vaccination of healthy young adults, influenza vaccination will be encouraged and will
             not lead to study exclusion)

          -  Planned administration of any flavivirus vaccine for the entire study duration

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Family history of congenital or hereditary immunodeficiency

          -  History of, or current auto-immune disease

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine/placebo or related to a study procedure

          -  Major congenital defects or serious chronic illness

          -  History of any neurological disorders or seizures

          -  Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of
             enrollment (a subject with a minor illness, i.e., mild diarrhea, mild upper
             respiratory infection, etc., without fever, may be enrolled at the discretion of the
             investigator)

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality,as determined by physical examination or laboratory screening
             tests

          -  Administration of immunoglobulins and/or any blood products during the period starting
             90 days preceding the first dose of study vaccine/placebo or planned administration
             during the study period

          -  History of chronic alcohol consumption and/or drug abuse

          -  Pregnant or lactating female or female planning to become pregnant or planning to
             discontinue contraceptive precautions

          -  A planned move to a location that will prohibit participating in the trial until study
             end for the participant

          -  Any other condition which, in the opinion of the investigator, prevents the subject
             from participating in the study.

          -  Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus
             antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)

          -  Safety laboratory test results that are outside the acceptable values at screening.
             The following values are not acceptable:

               -  >110% upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate
                  aminotransferase (AST), alkaline phosphatase, creatinine, serum urea nitrogen
                  (SUN) and bilirubin (total and direct)

               -  <100% lower limit of normal (LLN) or > 120% ULN for hemoglobin, hematocrit and
                  platelet count

               -  <75% LLN or >110% ULN for total white blood cell count (WBC) Note that all
                  screening laboratory results must be either within normal limits (WNL) or no more
                  than Grade l not clinically significant (NCS)

        (LLN=lower limit of normal; ULN= upper limit of normal, WNL= within normal limits, NCS= not
        clinically significant)