A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand
Condition: Dengue
MeSH terms: Dengue
Intervention: T-DEN F17; T-DEN F-19; Placebo Comparator
Intervention description: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.; A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.; A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 20 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This descriptive study will evaluate the safety and immunogenicity of different formulations
      of the WRAIR dengue vaccine compared to a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A healthy male or female adult 20-25 years of age (≥20 years of age and ≤25 years of
             age) at the time of vaccination;

          -  Free of obvious health problems as established by medical history and physical
             examination before entering into the study;

          -  Written informed consent obtained from the subject;

          -  Able to read the Subject Information Sheet and Consent Form;

          -  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) should
             be enrolled in the study;

          -  females must be of non-childbearing potential, i.e. surgically sterilized or, if of
             childbearing potential, she must be abstinent or on adequate contraceptive precautions
             (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent
             hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or
             injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy
             test within 48 hours prior to vaccination and must agree to continue such precautions
             for 60 days after completion of the vaccination series

        Exclusion Criteria:

          -  Pregnant or lactating 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 drug abuse or alcohol consumption (more than 2 drinks per day);

          -  History of allergic disease/reaction likely to be exacerbated by any component of the
             vaccine;

          -  Acute or chronic, 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 or
             seropositive for HBsAg, anti-HCV or anti-HIV;

          -  Acute disease at the time of enrollment (acute disease is defined as the presence of a
             moderate or severe illness with or without fever);

          -  Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;

          -  Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;

          -  Hypertension; chest pain, palpitations, dizziness, shortness of breath, arrhythmias or
             friction rubs;

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine within 30 days preceding the study vaccine (includes 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 days before the first dose of the study vaccine/placebo and
             ending 30 days after the second dose;

          -  A planned move to a location that will prohibit participating in the trial for 9
             months after the initial vaccination;

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 90 days 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 days preceding the
             first dose or planned administration during the study period;

          -  Any chronic systemic drug therapy to be continued during the study period (except for
             vitamin/mineral supplements or routine treatment for gastro-esophageal reflux);

          -  No easy access to a fixed or mobile telephone