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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

Must not have

Malignant disease treated with observation, surgery, or radiotherapy alone

Documented current/active, severe infection, as determined by the investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer was treated with only surgery, radiation, or monitoring.

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I do not have a severe infection right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vaccination comparison via objective lab measurements of vaccine titers

Secondary study objectives

Healthy Sibling comparison

Immune Abnormalities - Malignancy

Immune Abnormalities - Primary Vaccination Status

+2 more

Other study objectives

Safety - Potential Side Effects

Side effects data

From 2017 Phase 3 trial • 480 Patients • NCT02935192

Respiratory tract infection

Rhinitis

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Vaccine

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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, 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.

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 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vaccine

2013

Completed Phase 4

~3200

0 / 6Eligibility criteria met