Diarrhea Clinical Trial
Official title:
Effect of Diarrheal Disease on Bivalent Oral Polio Vaccine (bOPV) Immune Response in Infants in Nepal
Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have
been eliminated since 1988, outbreaks continue to occur, and new tools are needed to
accelerate eradication. One concern in this effort is that some populations have decreased
immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased
seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV)
was recommended for use in immunization campaigns, and will likely replace tOPV in routine
immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been
studied.
This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who
reside in Nepal. The investigators conducted a prospective, interventional study that
assessed immune response to bOPV among infants with and without diarrhea. Immune responses
were compared among infants with and without diarrhea.
This study will result in a better understanding of the factors that decrease the ability of
some children to seroconvert to OPV and be protected from poliomyelitis infection.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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