Verifying Antibodies After Live Immunization Delivery (VALID): A Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease, Measles Vaccination, Sickle Cell Anemia. Basic parameters: 6 months — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Ghana, Tanzania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Verifying Antibodies After Live Immunization Delivery (VALID): a Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease
Overview
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.
Primary outcome measures
- Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations [Time frame: From enrollment to the end of sample collection at 8 weeks]
Secondary outcome measures (4)
- Measles Seroconversion Rates 4 Weeks After MV1 Vaccination [Time frame: From enrollment to the end of sample collection at 4-weeks post first vaccination.]
- Measles Seroconversion Rates 4 Weeks after MV2 Vaccination [Time frame: From second vaccination to end of sample collection at 4-weeks post second vaccination.]
- Variables Associated with Measles Vaccine-induced Antibody Response [Time frame: From enrollment to the end of sample collection at 8 weeks.]
- Modalities for Sample Analysis [Time frame: Through study completion, an average of 12 weeks.]
Eligibility criteria
Inclusion criteria
- Participants with confirmed Sickle Cell Disease.
- Participants 6 months and 6 years of age and due for measles vaccination within 3 months per national guidelines.
- Willing and able to provide informed consent
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Ghana · 1 center
- Korle Bu Teaching Hospital — Accra
Tanzania · 1 center
- Bugando Medical Centre — Mwanza
Identifiers
NCT: NCT07356050 · VALID