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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| National Institutes of Health (NIH) | NIH |
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The goal of this study is to learn if infants with sickle cell disease (SCD) develop adequate protection after measles vaccines. (not looking at any prolonged duration)
Families of infants with SCD who are eligible for a measles vaccine per standard care will be contacted to discuss enrollment in the study. One cohort will be evaluated for response to the first measles vaccine (MV1) and another cohort will be evaluated for response to the second measles vaccine (MV2). Blood samples will be collected from participants prior to measles vaccination and then again at 4 and 8 weeks after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second Measles Vaccine (MV2) | Participants who receive second measles vaccine. | ||
| First Measles Vaccine (MV1) | Participants who obtain the first measles vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations | Sample analysis of 126 participants 8-weeks post complete measles vaccination. | From enrollment to the end of sample collection at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measles Seroconversion Rates 4 Weeks After MV1 Vaccination | Sample analysis of participants' seroconversion rates 4-weeks post first vaccination. | From enrollment to the end of sample collection at 4-weeks post first vaccination. |
| Measles Seroconversion Rates 4 Weeks after MV2 Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
1. Known primary immunodeficiency syndrome, cancer, or acquired immunodeficiency syndrome (AIDS) that would preclude vaccination with live virus vaccines.
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Children from 6 months to 6 years old with Sickle Cell Disease who receive medical care in Cincinnati, Ohio; Accra, Ghana; and Mwanza, Tanzania will be eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Latham | Contact | 513-803-7922 | Teresa.Latham@cchmc.org | |
| Amy Shova | Contact | (513) 803-1917 | Amy.Shova@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra Power-Hays, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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At maximum, 3 mL of whole blood will be collected from participants. Plasma will be separated from the whole blood sample.
The sample analysis of participant's seroconversion rates 4-weeks post second vaccination. |
| From second vaccination to end of sample collection at 4-weeks post second vaccination. |
| Variables Associated with Measles Vaccine-induced Antibody Response | Identify participant's demographic, clinical history, and sickle cell treatments as variables to measles antibody response. | From enrollment to the end of sample collection at 8 weeks. |
| Modalities for Sample Analysis | Compare sample analysis results between the gold standard (serum or plasma) and Mitra sample using dried blood spot or whole blood. | Through study completion, an average of 12 weeks. |
| Korle Bu Teaching Hospital | Recruiting | Accra | Ghana | Ghana |
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| Bugando Medical Centre | Recruiting | Mwanza | Tanzania |
|
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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