Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults
Condition: Dengue
MeSH terms: Dengue
Intervention: Pre-transfection F17; Post-transfection F17; Post-transfection F19; Placebo
Intervention description: Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection; Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.; Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.; Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This descriptive study will evaluate the safety and immunogenicity of 3 different
      formulations of the WRAIR dengue vaccine compared to a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A healthy male or female adult 18-45 years 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;

          -  If the subject is female, she must be of non-childbearing potential, i.e. either
             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; 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;

          -  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;

          -  History of urticaria related to mosquito bites requiring medical attention;

          -  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;

          -  Subject 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);

          -  (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., 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 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 each dose of the study vaccine and ending 30 days
             after;

          -  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, a single anti-hypertension medication or routine
             treatment for gastro-esophageal reflux).