Dengue Virus Clinical Trial
Official title:
A Phase I Evaluation of the Safety and Immunogenicity of rDEN2/4 Δ30(ME) Dengue Serotype 2 Vaccine Given at 10^1 PFU in Healthy Flavivirus-naïve Adult Subjects
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will test whether a vaccine developed to prevent infection with dengue virus type 2 causes a response in people's immune system and is safe.
Dengue viruses cause approximately 50 million cases of dengue fever and 1.5 million cases of
the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS)
every year. There are four subtypes of the virus, and infection with one offers no
protection from infection by the others. In fact, most cases of DHS and DSS occur in people
infected by more than one subtype. In areas of the world where multiple subtypes of dengue
are common, vaccines must be developed against each of the subtypes of dengue virus. This
study will examine the safety and immune response of an investigational vaccine for
preventing dengue virus type 2.
Participation in this study will last about 6 weeks. Participants will be randomly assigned
to be injected with either the investigational study vaccine or a placebo. Participants will
have a five in six chance of receiving the vaccine. The first study visit will take place on
the vaccination day, on which participants will undergo a physical examination, blood draw,
and pregnancy test and then receive the vaccine. Participants will be given a thermometer
and temperature card and be told to record their temperatures three times per day for 16
days after vaccination. Participants will come to follow-up visits every other day for the
16 days after vaccination and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and
42). Assessments completed during these visits will include a questionnaire about how the
participant is feeling, pregnancy test, review of temperature cards, blood draw, and
physical exam. Blood drawn will be analyzed to check participants' health, determine the
amount of vaccine and antibodies in the blood, test markers in white blood cells and genes,
and look for proteins that are important for fighting dengue infection.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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