Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy

Study Overview
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Brief Summary
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To compare the effects of a pneumococcal vaccine called PCV20 when given as a single dose versus a boosted regimen to patients who previously received anti-CD20 therapy as treatment for B cell lymphoma.

Detailed Description
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Primary Objectives: --Compare the humoral responses in terms of difference in IgG titers at 1 month from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy. Secondary Objectives: Compare the humoral responses in terms of difference in IgG titers at 3, 6 and12 from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy. Estimate the rate of pneumonia (all bacterial pneumonia including pneumococcal pneumonia) within a year from routine single dose PCV20 or a boosted PCV20 regimen in lymphoma survivors who previously received treatment with anti-CD 20 therapy. Correlate humoral responses to development of bacterial pneumonia and pneumococcal pneumonia and with severity of this infection in lymphoma survivors within a year of vaccination.

Official Title
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Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: PCV20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year. Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma. Patients who are at least 18 years of age. Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf. Exclusion Criteria: Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment. Patients who are unable to attend follow-up appointments at designated times at MD Anderson. Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Group A (PCV20)<br>Participants will receive 1 dose of the vaccine | Biological: PCV20<br>* Given by Injection into the muscle<br>|
| Experimental: Arm Group B (PCV20)<br>Participants will receive 2 doses of the vaccine | Biological: PCV20<br>* Given by Injection into the muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |  | through study completion; an average of 1 year |