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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI144673-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures
Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cincinnati IMPRINT birth cohort | mother-infant pairs enrolled at or after week 34 in pregnancy and followed over three flu seasons, up to four years of age. |
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| Measure | Description | Time Frame |
|---|---|---|
| Immune response to influenza virus infection | Evaluate the immune response to influenza virus infections due to various subtypes in healthy children from birth to 4 years of age in a maternal-infant birth cohort | 4 years |
| Immune response to influenza vaccination | Evaluate the immune response to influenza vaccination in healthy children from 6 months to 4 years of age in a maternal-infant birth cohort | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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We will seek to obtain a balanced temporal distribution of the cohort births to account for seasonal variations in influenza transmission patterns. We will seek to enroll 30 eligible women per month by posting advertisements via study flyers and brochures in the maternal clinics, social media, institutional wide emails, and each of the enrollment clinic sites. Our staff will screen pregnant women in clinic settings for inclusion/exclusion criteria and then consent and enroll those eligible to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Staat, MD,MPH | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45219 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Nasal swabs will be obtained weekly and will be tested for influenza A & B viruses by Real-Time Reverse Transcriptase PCR (RTrtPCR) analysis
Respiratory specimens will be stored at 2-8 degrees C and processed within 24-48 hours of collection
Serum and whole blood for immune assays will be processed and then frozen at -20 degrees C or in liquid nitrogen until tested in batch assays
All blood specimens will be sent to the laboratory for immunologic assays
Cheek swabs will be used for HLA typing
Saliva specimens will be used for immunologic assays
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |