Measles Vaccination, Sickle Cell Anemia, Sickle Cell Disease
Conditions
Keywords
Measles Vaccine Immunogenicity
Brief summary
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)
Detailed description
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.
Interventions
None listed
Sponsors
Children's Hospital Medical Center, Cincinnati
Thrasher Research Fund
National Institutes of Health (NIH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Participants with confirmed Sickle Cell Disease. 2. Participants 6 months and 6 years of age and due for measles vaccination within 3 months per national guidelines. 3. Willing and able to provide informed consent 4. Ability to comply with study related evaluations and follow-up visits.
Exclusion criteria
1\. Known primary immunodeficiency syndrome, cancer, or acquired immunodeficiency syndrome (AIDS) that would preclude vaccination with live virus vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations | From enrollment to the end of sample collection at 8 weeks | Sample analysis of 126 participants 8-weeks post complete measles vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measles Seroconversion Rates 4 Weeks After MV1 Vaccination | From enrollment to the end of sample collection at 4-weeks post first vaccination. | Sample analysis of participants' seroconversion rates 4-weeks post first vaccination. |
| Measles Seroconversion Rates 4 Weeks after MV2 Vaccination | From second vaccination to end of sample collection at 4-weeks post second vaccination. | The sample analysis of participant's seroconversion rates 4-weeks post second vaccination. |
| Variables Associated with Measles Vaccine-induced Antibody Response | From enrollment to the end of sample collection at 8 weeks. | Identify participant's demographic, clinical history, and sickle cell treatments as variables to measles antibody response. |
| Modalities for Sample Analysis | Through study completion, an average of 12 weeks. | Compare sample analysis results between the gold standard (serum or plasma) and Mitra sample using dried blood spot or whole blood. |
Countries
Ghana, Tanzania, United States
Contacts
CONTACTTeresa Latham
CONTACTAmy Shova
PRINCIPAL_INVESTIGATORAlexandra Power-Hays, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed