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

Last updated: May 12, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

4

Condition

Lymphoma

Treatment

PCV20

Clinical Study ID

NCT06049134
2023-0590
NCI-2023-07264
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease hasbeen in remission for at least 1 year.

  2. Patients who received any anti-CD20 therapy at any time during their treatment forB-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 toprovide consent on a patient's behalf.

Exclusion

Exclusion Criteria:

  1. Patients who have received cellular therapy, including chimeric antigen receptorT-cell therapy or any type of hematopoietic cell transplantation.

  2. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 yearsof screening for enrollment.

  3. Patients who are unable to attend follow-up appointments at designated times at MDAnderson.

  4. Any vulnerable population patient ((children, pregnant women, cognitively impairedadults, or prisoners)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: PCV20
Phase: 4
Study Start date:
October 06, 2023
Estimated Completion Date:
August 01, 2027

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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