Pediatric CancerPhase 2NCT04948619
Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients
A Phase 2 study testing Vaccine in people with Pediatric Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 60 days prior to date of enrollment/randomization
- 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/randomization
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Sceria Jenkins, RN, 980-442-2323, Sceria.Jenkins@advocatehealth.org
Ashley Hinson, MD, 704-381-9900, ashley.hinson@advocatehealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Vaccine
- Keywords
- Pediatric Oncology, Vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineBiological
Patients will have lab evaluations for immune function at baseline, 3, 6, 9 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Single booster vaccines | Other | Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. 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. Receives: Biological: Vaccine |
| Arm B - Staged revaccination series | Other | 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, and 9 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. Receives: Biological: Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination comparison via objective lab measurements of vaccine titers
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.
Measured: 2 years
Secondary outcomes (5)
Vaccine comparison at 12 & 24 months
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.
Measured: Up to 2 years
Infection Rates
Evaluate infection rates (over a 2-year post randomization period) between subjects with residual immune dysfunction versus subjects with recovered immune function
Measured: Up to 2 years
Healthy Sibling comparison
Evaluate infection rates in enrolled subjects and compare to healthy siblings, when applicable
Measured: Up to 2 years
Immune Abnormalities - Malignancy
Evaluate the prevalence of immune abnormalities at 12 and 24 months as a function of type of malignancy and length of treatment
Measured: Up to 2 years
Immune Abnormalities - Primary Vaccination Status
Evaluate the prevalence of immune abnormalities as a function of primary vaccination status
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start8 Aug 2022
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Ashley Hinson, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948619
- Sponsor's protocol ID
- IRB00081757
- Other IDs
- 00053603, LCI-PED-NOS-VACC-001
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer
- ClinicalTrials.gov ID
- NCT04948619
- Acronym / sponsor ID
- IRB00081757
- Conditions
- Pediatric Cancer
- Keywords
- Pediatric Oncology, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Single booster vaccines | Other | Biological: VaccineThose subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. 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. |
| Arm B - Staged revaccination series | Other | Biological: VaccineThose 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, and 9 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. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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 60 days prior to date of enrollment/randomization
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| VaccinePatients will have lab evaluations for immune function at baseline, 3, 6, 9 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. | Biological | Arm A - Single booster vaccines, Arm B - Staged revaccination series |
Primary outcome
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.
5 secondary outcomes
Vaccine comparison at 12 & 24 months
Time frame: Up to 2 years
Infection Rates
Time frame: Up to 2 years
Healthy Sibling comparison
Time frame: Up to 2 years
Immune Abnormalities - Malignancy
Time frame: Up to 2 years
Immune Abnormalities - Primary Vaccination Status
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ashley Hinson, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaccine in people with Pediatric Cancer, run by Wake Forest University Health Sciences at 1 site 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sceria Jenkins, RN (980-442-2323, Sceria.Jenkins@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination comparison via objective lab measurements of vaccine titers (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.