Acute Lymphoblastic Leukemia, PediatricVIRALNCT05622682

Vaccine Immune Recovery After Leukemia

An observational study of Acute Lymphoblastic Leukemia, Pediatric, run by Children's Hospital of Philadelphia at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 31 years
Conditions the study is for: Acute Lymphoblastic Leukemia, Pediatric
What is being tested?: Observational only: Serology and flow cytometry for ALL cohort participants and Observational only: Infection rates
Type of treatment: Vaccines
How many people: 89 participants
Where: 6 sitesUnited States
Study dates: 28 Sep 2022to 30 Nov 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 31 years
All sexes
No healthy volunteers
Child, Adult

Study population: Children, adolescents, and young adults receiving care at a participating pediatric oncology/hematology center who recently completed or will soon complete treatment for acute lymphoblastic leukemia

Who may be able to join

Children, adolescents, and young adults diagnosed with B or T ALL at age 12 months or older
Completed ALL chemotherapy within the past three months or will complete ALL chemotherapy in the upcoming three months
Three years of age or older at time of enrollment

Who cannot join

Diagnosis of infant ALL
Evidence of disease relapse
History of primary immunodeficiency (except related to Down Syndrome)
History of a stem cell transplant or cellular immunotherapy
History of prior malignancy or condition requiring chemotherapy other than for current ALL diagnosis

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
CHRISTUS Children's (Affiliate of Baylor College of Medicine)
San Antonio, Texas, 78207
Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: A Prospective Cohort Study to Define Infectious Burden, the Seroprevalence of Vaccine Preventable Pathogens and Immune Recovery in the First Year Following Completion of Therapy in Patients With Acute Lymphoblastic Leukemia (ALL)

This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll up to 100 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.

Conditions: Acute Lymphoblastic Leukemia, Pediatric
Being tested: Observational only: Serology and flow cytometry for ALL cohort participants, Observational only: Infection rates
Keywords: acute lymphoblastic leukemia, chemotherapy, antineoplastic agents, varicella vaccine, chickenpox vaccine, pneumococcal vaccines, measles vaccine
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Observational only: Serology and flow cytometry for ALL cohort participantsOther
Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery
Observational only: Infection ratesOther
Number of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy.

Study groups in NCT05622682
Study group	Role	What they receive
Children, adolescents, and young adults who recently completed ALL treatment		This cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery. Receives: Other: Observational only: Serology and flow cytometry for ALL cohort participants; Other: Observational only: Infection rates

What is being measured

The primary outcome is the main question the study is designed to answer.

Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy
Infections include clinical and/or microbiologically confirmed infections as well as patient-reported infections during follow-up. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per patient-year. Patients will be censored at time of loss to follow-up, relapse, or death.
Measured: 1 year

Secondary outcomes (3)

Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint
The seroprevalence proportions for measles antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.
Measured: 1 year
Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint
The seroprevalence proportions for varicella antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.
Measured: 1 year
Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint
The seroprevalence proportions for pneumococcal antibodies (23 serotypes) will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 202230 Nov 2025

First posted18 Nov 2022
Study start28 Sep 2022
Primary completion31 Oct 2025
Study completion30 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05622682
Sponsor's protocol ID: 21-019426
Other IDs: 61366
Acronym: VIRAL
Status last verified: Jan 2026
First submitted: 9 Nov 2022
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
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Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Acute Lymphoid Leukemia, Minimal Residual Disease
RecruitingObservational study
Feasibility and Acceptability of Remote Saliva Collection
Survivors of Childhood Cancer, Acute Lymphoblastic Leukemia, Childhood
Active, not recruitingPhase 2
Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
B Precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma

All Acute Lymphoblastic Leukemia, Pediatric trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Cohort Study to Define Infectious Burden, the Seroprevalence of Vaccine Preventable Pathogens and Immune Recovery in the First Year Following Completion of Therapy in Patients With Acute Lymphoblastic Leukemia (ALL)
ClinicalTrials.gov ID: NCT05622682
Acronym / sponsor ID: VIRAL / 21-019426
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Keywords: acute lymphoblastic leukemia, chemotherapy, antineoplastic agents, varicella vaccine, chickenpox vaccine, pneumococcal vaccines, measles vaccine
Study type: Observational
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 28 Sep 2022 (actual)
Primary completion: 31 Oct 2025 (actual)
Study completion: 30 Nov 2025 (actual)
First posted: 18 Nov 2022 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Children, adolescents, and young adults who recently completed ALL treatment	–	Other: Observational only: Serology and flow cytometry for ALL cohort participants, Other: Observational only: Infection ratesThis cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery.

Who may qualify

Ages: 3 to 31 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Children, adolescents, and young adults receiving care at a participating pediatric oncology/hematology center who recently completed or will soon complete treatment for acute lymphoblastic leukemia

Key inclusion criteria (3 listed)

Children, adolescents, and young adults diagnosed with B or T ALL at age 12 months or older
Completed ALL chemotherapy within the past three months or will complete ALL chemotherapy in the upcoming three months
Three years of age or older at time of enrollment

Key exclusion criteria (5 listed)

Diagnosis of infant ALL
Evidence of disease relapse
History of primary immunodeficiency (except related to Down Syndrome)
History of a stem cell transplant or cellular immunotherapy
History of prior malignancy or condition requiring chemotherapy other than for current ALL diagnosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Observational only: Serology and flow cytometry for ALL cohort participantsBlood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery	Other	Children, adolescents, and young adults who recently completed ALL treatment
Observational only: Infection ratesNumber of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy.	Other	Children, adolescents, and young adults who recently completed ALL treatment

Primary outcome

Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy
Time frame: 1 year
Infections include clinical and/or microbiologically confirmed infections as well as patient-reported infections during follow-up. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per patient-year. Patients will be censored at time of loss to follow-up, relapse, or death.

3 secondary outcomes

Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint
Time frame: 1 year
Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint
Time frame: 1 year
Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint
Time frame: 1 year

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Child, Adolescent, and Young Adult Survivors of Acute Lymphoblastic Leukemia	89	84

Primary outcome: Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy

Time frame: 1 year. Number. Unit: Events per person-year

Measure	Child, Adolescent, and Young Adult Survivors of Acute Lymphoblastic Leukemia n = 88
Value	3.60

Population analysed: Analyzed 88 total participants; 1 participant lost to follow-up between enrollment and first post-enrollment study encounter.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end of follow up, approximately 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Child, Adolescent, and Young Adult Survivors of Acute Lymphoblastic Leukemia	3 of 89 (3.4%)	0 of 89 (0%)	0 of 89

Limitations and caveats (from the sponsor): This study has several limitations. Because research blood draws were timed with clinical laboratory draws at off-therapy visits, only patients with consistent follow-up were included in the vaccine titer data. Similarly, for infection incidence rates, only patients who consistently followed up and participated in study encounters were captured, meaning that some infections - perhaps among patients more likely to be ill - may have been missed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Lymphoblastic Leukemia, Pediatric

RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
RecruitingObservational study
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Acute Lymphoid Leukemia, Minimal Residual Disease
RecruitingObservational study
Feasibility and Acceptability of Remote Saliva Collection
Survivors of Childhood Cancer, Acute Lymphoblastic Leukemia, Childhood
Active, not recruitingPhase 2
Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
B Precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian T Fisher, DO MSCE MPH principal investigator

Children's Hospital of Philadelphia

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Lymphoblastic Leukemia, Pediatric, run by Children's Hospital of Philadelphia at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.