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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 4

Conditions: Lymphoma

Treatments: Biological: PCV20

Study type: Interventional

Funder types: Other

Identifiers

NCT06049134

2023-0590

NCI-2023-07264 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year.
2. Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma.
3. Patients who are at least 18 years of age.
4. Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf.

Exclusion criteria

1. Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation.
2. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment.
3. Patients who are unable to attend follow-up appointments at designated times at MD Anderson.
4. Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm Group A (PCV20)

Experimental group

Description:

Participants will receive 1 dose of the vaccine

Treatment:

Biological: PCV20

Arm Group B (PCV20)

Experimental group

Description:

Participants will receive 2 doses of the vaccine

Treatment:

Biological: PCV20