Dengue Hemorrhagic Fever Clinical Trial
Official title:
Evaluation of the Safety and Immunogenicity of Heterologous Dengue Vaccine Administration in Dengue Immune Individuals
Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.
The World Health Organization estimates that dengue virus causes more than 50 million cases
of dengue fever a year. Dengue virus infection is the leading cause of hospitalization and
death in children of most tropical Asian countries. There are four different serotypes of
dengue virus. Most cases of dengue hemorrhagic fever/dengue shock syndrome are caused by
secondary infection with a dengue serotype different from the first serotype the individual
was infected with. A vaccine that would be effective in preventing infection by multiple
dengue serotypes is desirable. The purpose of this study is to determine the safety of and
immune response to two different dengue virus vaccines in individuals who have been
previously vaccinated against a different serotype.
This study will last at least 42 days. Participants will be recruited from a database of
previous dengue vaccine recipients and will be stratified by the type of vaccine previously
received. Participants assigned to Cohort 1 and Cohort 2 will have already been vaccinated
with the rDEN4delta30 vaccine. Participants assigned to Cohort 3 will have already been
vaccinated with the rDEN2/4delta30(ME) vaccine. Participants in Cohort 4 will have already
been vaccinated with the rDEN1delta30 vaccine. Participants in Cohorts 1 and 3 will be
randomly assigned to receive either the rDEN1delta30 vaccine or placebo. Participants in
Cohorts 2 and 4 will be randomly assigned to receive either the rDEN2/4delta30(ME) vaccine
or placebo.
Participants will receive their assigned vaccination on Day 0. Study visits will occur every
other day until Day 16, and then at Days 21, 28, and 42. At each visit, blood collection,
vital signs measurement, and a physical exam will occur. In addition, participants will be
asked to monitor their temperature daily, 3 times a day, from Day 0 to Day 16. Patients will
also be asked to enroll in an optional skin biopsy sub-study.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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