A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Shock
Intervention: Placebo; T-DEN-Post-Transfection F17; T-DEN-Post-Transfection F19
Intervention description: Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months; Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months; Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 636.0
Sex: All
Minimum age: 12 Months
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Virus; Live-attenuated; Vaccine; Dengue viral infection; Dengue Vaccine

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of two different
      formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two
      doses are given six months apart to adults and children.
    

Eligibility criteria:

        Inclusion Criteria:>

          -  Subjects who the investigator believes that they and/or their parents/guardians can
             and will comply with the requirements of the protocol (e.g., completion of the diary
             cards, return for follow-up visits) should be enrolled in the study.>

          -  A healthy male or non-pregnant female between 12 months (mths) and 50 years (yrs) of
             age at the time of the first vaccination;>

          -  Free of obvious health problems as established by medical history and physical
             examination before entering into the study;>

          -  For children: 23mths of age, full compliance with the United States Advisory Committee
             on Immunization Practices (U.S. ACIP) recommended childhood immunization schedule;>

          -  Written informed consent obtained from the subject or a parent/guardian and assent for
             subjects 7-20 yrs of age;>

          -  If the subject is female, she must be of non-childbearing potential, i.e. either
             pre-menarcheal, surgically sterilized or one year post-menopausal; or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions (i.e. intrauterine contraceptive device; condom and spermicide
             combination, oral contraceptives or other equivalent hormonal contraception, e.g.
             progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30
             days (dys) prior to vaccination, have a negative pregnancy test within 48 hrs prior to
             vaccination and must agree to continue such precautions for 60 dys after completion of
             the vaccination series. Any child who begins menarche during the study period must
             follow the same precautions listed above, from menarche until 60 dys after the second
             vaccine dose.>

        Exclusion Criteria:>

          -  Pregnant or lactating female;>

          -  Female planning to become pregnant or planning to discontinue abstinence or
             contraceptive precautions;>

          -  History of any neurological or behavioral disorder or seizures, with the exception of
             a single febrile seizure in childhood; >

          -  History of allergic disease/reaction likely to be exacerbated by any component of the
             vaccine;>

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal,
             hematologic or endocrine functional defect, as determined by physical examination or
             laboratory tests;>

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition;>

          -  Acute disease at the time of enrollment (acute disease is defined as the presence of a
             moderate or severe illness with or without fever); note that vaccine can be
             administered to persons with a minor illness such as diarrhea, mild upper respiratory
             infection with or without low-grade febrile illness, i.e., equivalent to an oral
             temperature <37.5°C/<99.5°F.>

          -  Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;>

          -  Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;>

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine within 30 dys preceding the first dose of study vaccine/placebo or planned use
             during the study period;>

          -  Planned administration of a vaccine not foreseen by the study protocol during the
             period starting from 30 dys before each dose of the study vaccine and ending 30 dys
             after; with the exception of standard infant and children "inactivated" vaccines or
             the inactivated influenza vaccine administered to adults or children; >

          -  A planned move to a location that will prohibit participating in the trial for the 12
             mth duration;>

          -  Chronic administration (defined as more than 14 dys) of immunosuppressants or other
             immune-modifying drugs within 90 dys preceding the first dose or planned
             administration during the study period. For corticosteroids, this will mean
             prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;>

          -  Administration of immunoglobulins and/or blood products within 90 dys preceding the
             first dose or planned administration during the study period;>

          -  Hypertension;>

          -  Chest pain, palpitations, dizziness, shortness of breath unrelated to asthma,
             arrhythmias or friction rubs;>

          -  Any chronic systemic drug therapy to be continued during the study period (except for
             vitamin/mineral supplements, routine treatment for gastro-esophageal reflux);>

          -  Potential adult volunteers, or parents of potential child volunteers, who do not have
             easy access to a fixed or mobile telephone;>

          -  History of chronic alcohol consumption and/or drug abuse.