Verifying Antibodies After Live Immunization Delivery (VALID): A Study of Measles Vaccine Immunogenicity in Children With Sickle Cell Disease (VALID)

January 20, 2026 updated by: Children's Hospital Medical Center, Cincinnati

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)

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ghana
    • Ghana
      • Accra, Ghana, Ghana
        • Recruiting
        • Korle Bu Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Catherine Segbefia, MBChB, FWACP, GGCPS
  • Tanzania
      • Mwanza, Tanzania
        • Recruiting
        • Bugando Medical Centre
        • Contact:
        • Principal Investigator:
          • Emmanuela Ambrose, MD, MMED
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • Charles Quinn, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Second Measles Vaccine (MV2)
Participants who receive second measles vaccine.
First Measles Vaccine (MV1)
Participants who obtain the first measles vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations
Time Frame: From enrollment to the end of sample collection at 8 weeks
Sample analysis of 126 participants 8-weeks post complete measles vaccination.
From enrollment to the end of sample collection at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measles Seroconversion Rates 4 Weeks After MV1 Vaccination
Time Frame: 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.
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.
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
Time Frame: 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Institutes of Health (NIH)
Thrasher Research Fund

Investigators

  • Principal Investigator: Alexandra Power-Hays, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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