Sickle Cell DiseaseVALIDNCT07356050
Verifying Antibodies After Live Immunization Delivery (VALID): A Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease
An observational study of Sickle Cell Disease and Measles Vaccination, run by Children's Hospital Medical Center, Cincinnati at 3 sites in 3 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Sickle Cell Disease, Measles Vaccination, Sickle Cell Anemia
- Type of treatment
- Vaccines
- How many people
- 130 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 13 Mar 2025to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 1. Known primary immunodeficiency syndrome, cancer, or acquired immunodeficiency syndrome (AIDS) that would preclude vaccination with live virus vaccines.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
MacKenzie Tasset, 513-803-4856, MacKenzie.Tasset@cchmc.org
Charles Quinn, MD
Ghana1 site, 1 recruiting
- Recruiting
Korle Bu Teaching Hospital
Accra, Ghana
Teresa Latham, 513-803-7922, Teresa.Latham@cchmc.org
Catherine Segbefia, MBChB, FWACP, GGCPS
Tanzania1 site, 1 recruiting
- Recruiting
Bugando Medical Centre
Mwanza
Teresa Latham, PhD, 513-803-7922, Teresa.Latham@cchmc.org
Emmanuela Ambrose, MD, MMED
About this study
Official title: Verifying Antibodies After Live Immunization Delivery (VALID): a Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease
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)
Read the 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.
- Conditions
- Sickle Cell Disease, Measles Vaccination, Sickle Cell Anemia
- Keywords
- Measles Vaccine Immunogenicity
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Second Measles Vaccine (MV2) | Participants who receive second measles vaccine. | |
| First Measles Vaccine (MV1) | Participants who obtain the first measles vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations
Sample analysis of 126 participants 8-weeks post complete measles vaccination.
Measured: From enrollment to the end of sample collection at 8 weeks
Secondary outcomes (4)
Measles Seroconversion Rates 4 Weeks After MV1 Vaccination
Sample analysis of participants' seroconversion rates 4-weeks post first vaccination.
Measured: From enrollment to the end of sample collection at 4-weeks post first vaccination.
Measles Seroconversion Rates 4 Weeks after MV2 Vaccination
The sample analysis of participant's seroconversion rates 4-weeks post second vaccination.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start13 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Alexandra Power-Hays, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356050
- Sponsor's protocol ID
- VALID
- Acronym
- VALID
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No