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| Name | Class |
|---|---|
| Tribhuvan University, Nepal | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diarrhea | Active Comparator | Infants with diarrhea will have blood and stool sample taken and receive zinc and ORS. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion. |
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| Non-diarrhea | Active Comparator | Infants without diarrhea will have blood and stool sample taken and receive multivitamins. They will then receive bivalent oral polio vaccine as the intervention. Four weeks later another blood sample will be drawn to measure seroconversion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bivalent oral polio vaccine | Biological | vaccine given during immunization campaigns |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after date of bOPV dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Date of enrollment |
| Proportion of infants seropositive after receipt of 3 doses of any oral polio vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina V Cardemil, MD, MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medicine | Kathmandu | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27085172 | Derived | Cardemil CV, Estivariz C, Shrestha L, Sherchand JB, Sharma A, Gary HE Jr, Oberste MS, Weldon WC 3rd, Bowen MD, Vinje J, Schluter WW, Anand A, Mach O, Chu SY. The effect of diarrheal disease on bivalent oral polio vaccine (bOPV) immune response in infants in Nepal. Vaccine. 2016 May 11;34(22):2519-26. doi: 10.1016/j.vaccine.2016.03.027. Epub 2016 Apr 13. |
| Label | URL |
|---|---|
| Global Polio Eradication Initiative | View source |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D011051 | Poliomyelitis |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009187 | Myelitis |
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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. |
| 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. | 4 weeks after date of bOPV dose |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |