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

Phase 4

Recruiting

• Conditions: Lymphoma
• Interventions: Biological: PCV20

• Registration Number: NCT06049134
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Study Start: 2023-10-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm Group B (PCV20)	PCV20	Participants will receive 2 doses of the vaccine
Arm Group A (PCV20)	PCV20	Participants will receive 1 dose of the vaccine

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States