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Cancer Vaccine

Vaccine Response After Cancer Therapy in Pediatric Patients

Phase 2
Recruiting
Led By Ashley Hinson, MD
Research Sponsored by Atrium Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5.5 years
Awards & highlights

Study Summary

This trial will look at whether cancer survivors are more likely to get infections and whether earlier vaccinations can help prevent these infections.

Who is the study for?
This trial is for pediatric cancer survivors aged 2-21 who've finished their cancer therapy within the last 60 days. They should be able to perform daily activities (with some assistance if needed) and comply with study procedures. It's not for those treated only with surgery or radiotherapy, with severe vaccine allergies, immune deficiencies, pregnancy, or active severe infections.Check my eligibility
What is being tested?
The study evaluates how well pediatric cancer survivors' immune systems work after treatment and how they respond to vaccinations given earlier than usual—at just 3 months post therapy. The goal is to see if this timing or revaccination can better protect against serious infections.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, vaccines may typically cause mild reactions like soreness at the injection site, fever, fatigue, headache and muscle pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer was confirmed by tests and is being treated by Levine Children's Hospital.
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I have had cancer before and received at least one round of treatment for it.
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I am between 2 and 21 years old.
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It has been less than 60 days since my last cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccination comparison via objective lab measurements of vaccine titers
Secondary outcome measures
Healthy Sibling comparison
Immune Abnormalities - Malignancy
Immune Abnormalities - Primary Vaccination Status
+2 more
Other outcome measures
Safety - Potential Side Effects

Side effects data

From 2017 Phase 3 trial • 480 Patients • NCT02935192
2%
Respiratory tract infection
1%
Rhinitis
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Vaccine

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B - Staged revaccination seriesExperimental Treatment1 Intervention
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.
Group II: Arm A - Single booster vaccinesExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vaccine
2013
Completed Phase 4
~3200

Find a Location

Who is running the clinical trial?

Atrium Health Levine Cancer InstituteOTHER
18 Previous Clinical Trials
1,470 Total Patients Enrolled
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,790 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,422 Total Patients Enrolled

Media Library

Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04948619 — Phase 2
Pediatric Cancer Research Study Groups: Arm A - Single booster vaccines, Arm B - Staged revaccination series
Pediatric Cancer Clinical Trial 2023: Vaccine Highlights & Side Effects. Trial Name: NCT04948619 — Phase 2
Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04948619 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are needed for this clinical trial?

"The clinical trial is currently looking for patients, as the data on clinicaltrials.gov show. This specific trial was first posted on 3/15/2022 and has been updated as recently as 5/11/2022. The study needs 64 participants from 1 site in total."

Answered by AI

Is this research opportunity still available to new participants?

"This clinical trial is actively seeking candidates, according to the information available on clinicaltrials.gov. The original posting date for this trial was 3/15/2022, and it was last updated on 5/11/2022."

Answered by AI

What are some of the risks associated with this treatment?

"The lack of evidence for this treatment's efficacy resulted in a safety score of 2."

Answered by AI

Who can sign up to participate in this medical research?

"This clinical trial is seeking pediatric cancer patients aged 2-21. They are looking to enroll around 64 total participants."

Answered by AI

Would you consider enrolling an octogenarian in this research project?

"The age limit for this clinical trial is 21 years old. Any patients that younger than 2 or older are unfortunately ineligible."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients
Ashley Hinson 2022. "Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948619.
All > Pediatric Cancer
~18 spots leftby Jan 2025
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