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NCT Number: NCT07356050

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)

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Measles Vaccination Sickle Cell Anemia

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Korle Bu Teaching Hospital, Accra, Ghana

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Shova

CONTACT

[email protected]

(513) 803-1917

Teresa Latham

CONTACT

[email protected]

513-803-7922

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Institutes of Health (NIH)
  • Thrasher Research Fund

Registry information

Acronym: VALID

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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