PCV20 Vaccine for Lymphoma Survivors

Recruiting in Palo Alto (17 mi)

Overseen by Fareed Khawaja, M D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cellular therapy, PCV, vulnerable, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the PCV20 vaccine safe for humans?

The PCV20 vaccine, also known as Prevnar 20, has been shown to be safe in adults and children, with a safety profile similar to earlier versions of the vaccine. It was well-tolerated in clinical trials, with no significant increase in serious side effects compared to previous vaccines. ^{1 2 3 4 5}

How is the PCV20 vaccine unique for lymphoma survivors?

The PCV20 vaccine is unique because it expands protection against pneumococcal infections by covering 20 different serotypes of the bacteria, compared to previous vaccines like PCV13, which covered only 13 serotypes. This broader coverage is particularly beneficial for lymphoma survivors who may be at higher risk for infections. ^{2 3 5 6 7}

Research Team

Fareed Khawaja, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf

My B-cell lymphoma has been in remission for at least a year.

I have received anti-CD20 therapy for my B-cell lymphoma.

Exclusion Criteria

Any vulnerable population patient (children, pregnant women, cognitively impaired adults, or prisoners)

I have received a pneumonia vaccine in the last 5 years.

Patients who are unable to attend follow-up appointments at designated times at MD Anderson

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single dose or a boosted regimen of the PCV20 vaccine

1 month

Follow-up

Participants are monitored for humoral responses and incidence of pneumonia

12 months

Treatment Details

Interventions

• PCV20 (Cancer Vaccine)

Trial Overview 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.

Participant Groups

Group I: Arm Group B (PCV20) Experimental Treatment 1 Intervention

Participants will receive 2 doses of the vaccine

Group II: Arm Group A (PCV20) Experimental Treatment 1 Intervention

Participants will receive 1 dose of the vaccine

PCV20 is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Prevnar 20 for:

• Prevention of invasive pneumococcal disease (IPD) caused by the 20 serotypes contained in the vaccine in infants and children six weeks through 17 years of age
• Prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar

🇨🇦 Approved in Canada as Prevnar 20 for:

• Prevention of invasive pneumococcal disease (IPD) caused by the 20 serotypes contained in the vaccine

🇪🇺 Approved in European Union as Prevnar 20 for:

• Prevention of invasive pneumococcal disease (IPD) caused by the 20 serotypes contained in the vaccine

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Tseng, HF., Sy, LS., Liu, IL., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. Shirley, M.[2023]

In a study of 44 pediatric oncology patients, the heptavalent pneumococcal conjugate vaccine (PCV-7) resulted in protective antibody levels against all seven targeted serotypes, with increases in antibody concentrations ranging from 3.8-fold to 85.8-fold.

No cases of invasive pneumococcal disease were reported among the patients during the study, indicating that PCV-7 is effective in eliciting a strong immune response in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. Cheng, FW., Ip, M., Chu, YY., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine in Older People. Sewell, HE., Conway, S., Douglas, C.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. Shirley, M.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Cannon, K., Elder, C., Young, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumococcal conjugate vaccine triggers a better immune response than pneumococcal polysaccharide vaccine in patients with chronic lymphocytic leukemia A randomized study by the Swedish CLL group. Svensson, T., Kättström, M., Hammarlund, Y., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine in Older People. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Pneumococcal conjugate vaccine triggers a better immune response than pneumococcal polysaccharide vaccine in patients with chronic lymphocytic leukemia A randomized study by the Swedish CLL group. [2018]