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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
699
vaccine given during immunization campaigns
Institute of Medicine
Kathmandu, Nepal
The proportion of infants who seroconvert or boost in antibody titers in the diarrhea arm compared to the non-diarrhea arm
Seropositive: antibody titer of at least 1:8 for poliovirus type 1 or 3 Seronegative: antibody titer of less than 1:8 for poliovirus type 1 or 3 Seroconversion: proportion of children who change from seronegative to seropositive to types 1 or 3, four weeks after receipt of bOPV. Boost (increase in titer): seropositives at baseline who increase at least 4-fold in antibody titer four weeks after receipt of bOPV.
Time frame: 4 weeks after date of bOPV dose
Frequencies of enteric infections isolated in stool among infants with diarrhea vs. infants without diarrhea
One stool sample will be collected from each infant the day of enrollment.
Time frame: Date of enrollment
Proportion of infants seropositive after receipt of 3 doses of any oral polio vaccine
A subset of infants who received two doses of any OPV prior to study entry, and a third dose of bOPV as part of the study, will have their seroimmunity reported. This outcome is intended as a proxy measure for seroprevalence after 3 doses of OPV, which is how the vaccine is used in routine immunization.
Time frame: 4 weeks after date of bOPV dose
Proportion of infants with factors associated with poor bOPV seroconversion/boosting
Multivariable modeling will be used to assess factors associated with poor bOPV seroconversion/boosting.
Time frame: 4 weeks after date of bOPV dose
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