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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-6
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

130 Participants
are grouped into 2 trial groups
Group A: Second Measles Vaccine (MV2)
Group B: First Measles Vaccine (MV1)

Trial outcomes

Primary outcomes

1

Measles Seroconversion Rates 8 Weeks After MV1 and MV2 Vaccinations

Sample analysis of 126 participants 8-weeks post complete measles vaccination.

Time frame
From enrollment to the end of sample collection at 8 weeks

Secondary outcomes

1

Measles Seroconversion Rates 4 Weeks After MV1 Vaccination

Sample analysis of participants' seroconversion rates 4-weeks post first vaccination.

Time frame
From enrollment to the end of sample collection at 4-weeks post first vaccination.
2

Measles Seroconversion Rates 4 Weeks after MV2 Vaccination

The sample analysis of participant's seroconversion rates 4-weeks post second vaccination.

Time frame
From second vaccination to end of sample collection at 4-weeks post second vaccination.
3

Variables Associated with Measles Vaccine-induced Antibody Response

Identify participant's demographic, clinical history, and sickle cell treatments as variables to measles antibody response.

Time frame
From enrollment to the end of sample collection at 8 weeks.
4

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.

Time frame
Through study completion, an average of 12 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Thrasher Research Fund

Collaborator

National Institutes of Health (NIH)

Collaborator