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Cancer Vaccine

PCV20 Vaccine for Lymphoma Survivors

Phase 4
Recruiting
Led By Fareed Khawaja, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment
Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a vaccine called PCV20 to protect against pneumonia in patients who had B cell lymphoma and were treated with anti-CD20 therapy. The vaccine helps the immune system produce antibodies to fight off the bacteria causing pneumonia. PCV20 was developed to expand protection against pneumococcal disease beyond the previous vaccine by including additional components.

Who is the study for?
This trial is for adults over 18 who've had B-cell non-Hodgkin lymphoma, are in remission for at least a year, and have previously been treated with anti-CD20 therapy. They must be able to consent themselves and commit to follow-up appointments. Those vaccinated against pneumococcus within the last 5 years or who've had certain cell therapies can't join.
What is being tested?
The study tests the PCV20 vaccine's effectiveness in two ways: one group gets a single dose, while another receives an additional booster shot. The goal is to see which method better stimulates immunity in lymphoma survivors treated with anti-CD20 therapy.
What are the potential side effects?
Potential side effects of the PCV20 vaccine may include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or mild fever. These reactions are generally short-lived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received anti-CD20 therapy for my B-cell lymphoma.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a pneumonia vaccine in the last 5 years.
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I have undergone cellular therapy, such as CAR T-cell therapy or a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 2663 Patients • NCT05425732
52%
Injection site pain
20%
Fatigue
15%
Headache
9%
Injection site swelling
7%
Myalgia
7%
Injection site erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: PCV20
Cohort 2: V116
Cohort 2: PCV20
Cohort 1: V116
Unplanned Participants

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm Group B (PCV20)Experimental Treatment1 Intervention
Participants will receive 2 doses of the vaccine
Group II: Arm Group A (PCV20)Experimental Treatment1 Intervention
Participants will receive 1 dose of the vaccine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCV20
2023
Completed Phase 3
~3780

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for lymphoma include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while immunotherapy, such as anti-CD20 therapy, stimulates the immune system to recognize and destroy cancer cells. Targeted therapies, like bispecific antibodies, bind to specific proteins on cancer cells to facilitate their destruction by the immune system. These mechanisms are crucial for lymphoma patients as they offer multiple strategies to combat the disease, potentially leading to better outcomes and fewer side effects compared to traditional treatments.
A Comparative and Comprehensive Review of Antibody Applications in the Treatment of Lung Disease.Combinatorial therapy of immune checkpoint and cancer pathways provides a novel perspective on ovarian cancer treatment.Current therapeutic strategies for advanced pancreatic cancer: A review for clinicians.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,050 Previous Clinical Trials
1,798,811 Total Patients Enrolled
258 Trials studying Lymphoma
32,554 Patients Enrolled for Lymphoma
Fareed Khawaja, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~13 spots leftby Jul 2025