Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients

Pediatric Cancer Clinical Trial

Official title:

Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948619
• Other study ID #: IRB00081757
• Secondary ID: 00053603LCI-PED-
• Status: Recruiting
• Phase: Phase 2
• Start date: August 8, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Sceria Jenkins, RN
• Phone: 980-442-2323
• Email: sceria.jenkins[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.

2. Age greater than or equal to 2 years and less than 22 years at the time of consent

3. Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 30 days prior to date of enrollment

4. Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital

5. History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy

6. Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment

7. 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:

1. Malignant disease treated with observation, surgery, or radiotherapy alone

2. Known coexisting immunodeficiency

3. Subjects with normal baseline titers for all investigated vaccines

4. Known pregnancy

5. Documented previous severe allergic reaction to any vaccine or component of a vaccine

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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety - Potential Side Effects	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
Primary	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.	2 years
Secondary	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.	Up to 2 years
Secondary	Infection Rates	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
Secondary	Healthy Sibling comparison	Evaluate infection rates in enrolled subjects and compare to healthy siblings, when applicable	Up to 2 years
Secondary	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	Up to 2 years
Secondary	Immune Abnormalities - Primary Vaccination Status	Evaluate the prevalence of immune abnormalities as a function of primary vaccination status	Up to 2 years