Clinical Trial: Prospective Study of Infant Dengue
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: A Prospective Study of Dengue Virus Infections During Infancy to Define Correlates of Protective Immunity
Brief Summary: Dengue is a common disease and a major health concern in the Philippines. Dengue is caused by a virus transmitted from the bite of an infected mosquito. The purpose of this study is to understand why some infants remain well or have a mild illness, and why other infants become very sick from this virus. Studies have shown that the mother's immune response to dengue can play a role in the infant's immune response and affect whether or not the infant becomes sick. This study will enroll up to 10,000 healthy infants 6-14 weeks old and their mothers in San Pablo City. At the first study visit, information about the mother and birth will be collected and blood samples will be taken from the mother and infant. The infant will have blood drawn at all 3 study visits. The infants will be followed until the age of 16 months. The information obtained from this study may help in the development and future testing of a safe and effective dengue vaccine.
Detailed Summary: This is a prospective natural history study to define the levels of maternally-acquired neutralizing antibody (Ab) and other correlates of immunity that may protect against the development of dengue hemorrhagic fever in infants. Approximately 10,000 mother-infant pairs will be enrolled to achieve a continuous study cohort of approximately 4,000 children less than 16 months of age. Children leave the study when they reach 16 months of age and are replaced by new participants at 6-14 weeks of age. The investigators will recruit study participants among 3rd trimester pregnant women receiving pre-natal care and women with newborns receiving post-natal care in San Pablo City. The first aim of this study is to define levels of serotype-specific neutralizing Abs associated with protective immunity against symptomatic dengue virus (DV). Neutralizing Ab titers in blood samples collected from Filipino infants before DV infection, and predicted neutralizing Ab titers at the time of illness, will be correlated with disease severity rankings and peak viremia levels. Neutralizing Ab titers at which infants developed symptomatic dengue will be determined. The second aim will be to delineate risk factors contributing to the pathogenesis of dengue hemorrhagic fever (DHF) in infants. From pre-illness blood samples, the association of Ab neutralizing capacity or enhancement of infection with DHF will be measured while controlling for other potential covariates. The covariates will include measures representing viral load and infant host immune responses. The third aim will be to strengthen the capacity for diagnosis and research on dengue in the Philippines. A collaborative and international consortium has been formed to advance dengue research in the Philippines. The research will generate vital data for the effective testing of dengue vaccines and future public health vaccination campaigns throughout the region. This study will enroll up to 10,000 healthy infants 6-14 weeks old and
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: September 14, 2006
Date Started: September 2006
Date Completion: September 2010
Last Updated: August 26, 2010
Last Verified: October 2007
