- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948619
Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients
April 12, 2024 updated by: Wake Forest University Health Sciences
Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer
Pediatric cancer survivors have increased infection-related morbidity and mortality.
This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable.
The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.
Study Overview
Detailed Description
This study is a prospective, randomized trial.
The target population is all patients between the ages of 2 and 21 years of age who complete cancer directed systemic therapy for any malignant diagnosis at our center over a 2 to 3-year time frame.
The study will be conducted in the various disease-specific off therapy and survivorship clinics of Levine Children's Cancer and Blood Disorders.
Patients will have lab evaluations for immune function at baseline, 3, 6, 12, and 24 months from last dose of cancer directed systemic therapy.
At 3 months from last dose of cancer directed systemic therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.
Vaccines given will be directed against Haemophilus influenza type B, tetanus, diphtheria, pertussis, polio, hepatitis B, Streptococcus pneumoniae, measles, mumps, rubella, and varicella.
Live vaccines (measles, mumps, rubella, and varicella) will be given at 6 months from last dose of cancer directed systemic therapy.
Repeat vaccine antibody titers will be assessed at follow up visits as above to determine if there are differences in immediate or maintained immunity based on vaccine strategy used.
For subjects <18 years of age, we will present health questionnaires to their caregiver to answer at each of the time points.
Subjects ≥18 years of age will complete their own health questionnaire.
These questionnaires will assess frequency, type, and severity of viral and bacterial infections requiring antibiotics in study patients and their closest healthy sibling in age, when applicable.
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sceria Jenkins, RN
- Phone Number: 980-442-2323
- Email: sceria.jenkins@atriumhealth.org
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Levine Cancer Institute
-
Contact:
- Sceria Jenkins, RN
- Phone Number: 980-442-2323
- Email: sceria.jenkins@atriumhealth.org
-
Contact:
- Ashley Hinson, MD
- Phone Number: 704-381-9900
- Email: ashley.hinson@atriumhealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
- Age greater than or equal to 2 years and less than 22 years at the time of consent
- Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 30 days prior to date of enrollment
- Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
- History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy
- Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment
- As determined by the enrolling physician, ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
Exclusion Criteria:
- Malignant disease treated with observation, surgery, or radiotherapy alone
- Known coexisting immunodeficiency
- Subjects with normal baseline titers for all investigated vaccines
- Known pregnancy
- Documented previous severe allergic reaction to any vaccine or component of a vaccine
- Documented current/active, severe infection, as determined by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm A - Single booster vaccines
Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 and 12 month visits.
Boosters for live vaccines will be given at the 6 month visit.
Boosters will only be given as applicable for low titers tested at the baseline assessment visit.
Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.
|
Patients will have lab evaluations for immune function at baseline, 3, 6, 12, and 24 months post completion of treatment.
At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.
|
Other: Arm B - Staged revaccination series
Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline.
When indicated, non-live vaccines will be given at the 3, 6, 9, and 12 month visits, live vaccines will be given at the 6 and 9 month visit.
Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.
|
Patients will have lab evaluations for immune function at baseline, 3, 6, 12, and 24 months post completion of treatment.
At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccination comparison via objective lab measurements of vaccine titers
Time Frame: 2 years
|
To compare single booster vaccination (Arm A) to full revaccination (Arm B) in terms of immune response at 24 months post cancer directed systemic therapy in pediatric subjects who have received cancer directed systemic therapy for any malignancy.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccine comparison at 12 & 24 months
Time Frame: Up to 2 years
|
To compare single booster vaccination to full revaccination in pediatric subjects who have received cancer directed systemic therapy for any malignancy in terms of the prevalence of immune abnormalities at 12 and 24 months completion.
|
Up to 2 years
|
Infection Rates
Time Frame: Up to 2 years
|
Evaluate infection rates (over a 2-year post randomization period) between subjects with residual immune dysfunction versus subjects with recovered immune function
|
Up to 2 years
|
Healthy Sibling comparison
Time Frame: Up to 2 years
|
Evaluate infection rates in enrolled subjects and compare to healthy siblings, when applicable
|
Up to 2 years
|
Immune Abnormalities - Malignancy
Time Frame: Up to 2 years
|
Evaluate the prevalence of immune abnormalities at 12 and 24 months as a function of type of malignancy and length of treatment
|
Up to 2 years
|
Immune Abnormalities - Primary Vaccination Status
Time Frame: Up to 2 years
|
Evaluate the prevalence of immune abnormalities as a function of primary vaccination status
|
Up to 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety - Potential Side Effects
Time Frame: Up to 5.5 years
|
To summarize the rates of potential side effects thought by the investigator to be related to each vaccine strategy, including fever, rash, myalgias, injection site reaction, infection, or anaphylaxis.
|
Up to 5.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ashley Hinson, MD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2022
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 24, 2021
First Posted (Actual)
July 2, 2021
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00081757
- 00053603 (Other Identifier: Advarra IRB)
- LCI-PED-NOS-VACC-001 (Other Identifier: Atrium Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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