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

NCT07356050 | Recruiting

• 1 other identifier: VALID
• Study Type: observational
• Target: 130
• Locations: 3 countries
• Sites: 3

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)

Conditions

Sickle Cell Disease; Measles Vaccination; Sickle Cell Anemia

Keywords

Measles Vaccine Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Measles Seroconversion Rates 4 Weeks After MV1 Vaccination

  From enrollment to the end of sample collection at 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.

• Variables Associated with Measles Vaccine-induced Antibody Response

  From enrollment to the end of sample collection at 8 weeks.

• Modalities for Sample Analysis

  Through study completion, an average of 12 weeks.

Study Arms (2)

Second Measles Vaccine (MV2)

Participants who receive second measles vaccine.

First Measles Vaccine (MV1)

Participants who obtain the first measles vaccine.

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. Known primary immunodeficiency syndrome, cancer, or acquired immunodeficiency syndrome (AIDS) that would preclude vaccination with live virus vaccines.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Thrasher Research Fund: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Korle Bu Teaching Hospital

Accra, Ghana, Ghana

RECRUITING

Bugando Medical Centre

Mwanza, Tanzania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

At maximum, 3 mL of whole blood will be collected from participants. Plasma will be separated from the whole blood sample.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alexandra Power-Hays, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Latham

CONTACT

513-803-7922; Teresa.Latham@cchmc.org

Amy Shova

CONTACT

(513) 803-1917; Amy.Shova@cchmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 21, 2026
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1); US (1); GH (1)