ClinicalTrials.gg
RecruitingNCT07356050VALIDUpdated Jan 21, 2026

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

An observational study in Sickle Cell Disease, Measles Vaccination and Sickle Cell Anemia, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 3 sites in 3 countries. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
6 Months to 6 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sickle Cell Disease
  • Measles Vaccination
  • Sickle Cell Anemia

Browse trials for

Keywords

  • Measles Vaccine Immunogenicity
03

In context

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

This study's planned enrollment of 130 is above the median of 100 across 296 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  4. Ability to comply with study related evaluations and follow-up visits.

Exclusion criteria

Exclusion Criteria:

1. Known primary immunodeficiency syndrome, cancer, or acquired immunodeficiency syndrome (AIDS) that would preclude vaccination with .

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Second Measles Vaccine (MV2)

    Participants who receive second measles vaccine.

  • First Measles Vaccine (MV1)

    Participants who obtain the first measles vaccine.

06

What researchers measure

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.

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Dec 2027, 33 months after the start.

Of 130 non-industry observational studies under Anemia, Sickle Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 109. This study's planned 33 months is below that.

Counting every sponsor, half of 139 studies reached it within 49 months; a quarter within 24 and three quarters within 109.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2026
First posted
Jan 21, 2026
StartActual
Mar 13, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Jan 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07356050
Collaborators
Thrasher Research Fund, National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Mar 13, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 21, 2026

Study contacts

Teresa Latham
Contact
Teresa.Latham@cchmc.org
513-803-7922
Amy Shova
Contact
Amy.Shova@cchmc.org
(513) 803-1917
Alexandra Power-Hays, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion