A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults
Condition: Dengue
MeSH terms: Dengue
Intervention: Live attenuated tetravalent dengue vaccine; Placebo
Intervention description: Live attenuated tetravalent dengue vaccine; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue infection

Summary:

      This descriptive study will evaluate the safety and immunogenicity of 5 different
      formulations of the WRAIR dengue vaccine compared to a placebo.
    

Eligibility criteria:

        Inclusion:

          -  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

          -  Females must be of non-childbearing potential, or, if of childbearing potential, she
             must be abstinent or have used adequate contraceptive precautions as defined in the
             protocol 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:

        History of:

          -  recurrent migraine headache

          -  any neurological or behavioral disorder or seizures

          -  drug abuse or alcohol consumption (more than 2 drinks per day)

          -  allergic disease/reaction likely to be exacerbated by vaccine

          -  urticaria related to mosquito bites requiring medical attention

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal,
             hematologic or endocrine functional defect

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition;

          -  Seropositive for HBsAg, anti-HCV or anti-HIV

          -  Acute disease at the time of enrollment

          -  Chronic hepatomegaly or splenomegaly

          -  Use of any investigational or non-registered drug or vaccine within 30 days preceding
             study or planned use

          -  Planned administration of a vaccine not foreseen by the study protocol 30 days ±each
             vaccine dose

          -  Planned move during study

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs or 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