PCV20 Vaccine for Lymphoma Survivors

Overseen By Fareed Khawaja, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cellular therapy, PCV, vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine called PCV20 to evaluate its effectiveness in individuals who had B-cell lymphoma and received anti-CD20 therapy. The researchers aim to determine whether one dose or two doses of the vaccine is more effective. Individuals in remission from non-Hodgkin B-cell lymphoma for at least a year, who have not received certain other treatments, might be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved vaccine and seeks to understand how it benefits a broader range of patients.

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.

What is the safety track record for the PCV20 vaccine?

Research has shown that the PCV20 vaccine is generally safe and well-tolerated. In studies, most side effects were mild, such as soreness at the injection site or a mild fever. A safety report found that out of nearly 2,000 cases where adults received the vaccine, only about 6% experienced serious side effects. Serious reactions are rare. However, individuals with a severe allergy to any component of the vaccine should not receive it. Overall, the vaccine is considered safe, with serious issues being uncommon. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for lymphoma survivors, which typically involves chemotherapy and targeted therapies, the PCV20 vaccine is unique because it is designed to boost the immune system by targeting specific pathogens. Researchers are excited about PCV20 because it may enhance the body's natural defenses, reducing the risk of infections that lymphoma survivors can be particularly vulnerable to. This vaccine approach could offer a novel way to improve the quality of life for survivors by potentially providing long-lasting protection with just one or two doses.

What evidence suggests that the PCV20 vaccine could be effective for lymphoma survivors?

Studies have shown that the PCV20 vaccine effectively boosts the immune system in people who have survived lymphoma. In this trial, participants in Arm Group A will receive one dose of PCV20, while those in Arm Group B will receive two doses. Previous research indicates that two doses of PCV20 lead to a stronger immune response than one dose for these individuals. This is particularly important for those who have received anti-CD20 therapy, as their immune systems might be weaker. The vaccine is also safe and effective for other age groups. Overall, PCV20 has proven to protect against pneumococcal infections, which can be serious for people with a history of lymphoma. ^{5 6 7 8 9}

Who Is on the Research Team?

Fareed Khawaja, M D

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PCV20

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well-tolerated in adults aged 65 and older, with similar rates of local reactions and adverse events compared to the control groups (PCV13 and PPSV23).

PCV20 elicited strong immune responses against all 20 serotypes included in the vaccine, demonstrating its effectiveness in boosting immunity regardless of prior pneumococcal vaccination history.

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]

A large safety monitoring study involving 599,229 doses of the 13-valent pneumococcal vaccine (PCV13) found no increased risk of serious adverse events like febrile seizures or anaphylaxis in children aged 1 month to 2 years.

While no significant increased risk of adverse events was identified compared to the previous 7-valent vaccine (PCV7), a potential association with Kawasaki disease warrants further investigation.

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]

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]

In a study of 128 untreated chronic lymphocytic leukemia (CLL) patients, the 13-valent pneumococcal conjugated vaccine (PCV13) produced a significantly stronger immune response compared to the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for most serotypes, both one and six months after vaccination.

Both vaccines were well tolerated, but PCV13 is recommended for inclusion in vaccination programs for CLL patients due to its superior efficacy in eliciting immune responses against Streptococcus pneumoniae.

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]

The newly licensed 20-valent pneumococcal conjugate vaccine (PCV20) effectively induces strong immune responses against all 20 serotypes of Streptococcus pneumoniae, expanding coverage beyond the 13 serotypes included in PCV13.

PCV20 has a safety and tolerability profile similar to PCV13, making it a promising option for further reducing the incidence of pneumococcal disease in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

The 20-valent pneumococcal conjugate vaccine (PCV20) has been approved for use in adults since June 2021 and in pediatric populations since April 2023, targeting a broader range of Streptococcus pneumoniae serotypes compared to the previous 13-valent vaccine.

PCV20 is effective in preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 17 years, demonstrating its safety and immunogenicity in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

The 20-valent pneumococcal vaccine (PCV20) has been shown to elicit a strong immune response in older adults (65 years and older) one month after vaccination, based on two randomized controlled trials.

PCV20 is well-tolerated, with adverse events comparable to previous pneumococcal vaccines, suggesting it is a safe option for older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06049134

Study Details | NCT06049134 | Immunogenicity and ... Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy.

2. pharmacytimes.com pharmacytimes.com/view/two-doses-of-pcv20-in-lymphoma-survivors-elicits-greater-humoral-response

Two Doses of PCV20 in Lymphoma Survivors Elicits ... Two doses of PCV20 in lymphoma survivors led to a stronger humoral response than one dose at 1 and 3 months post-vaccination. Significant ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/424615

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

4. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0590.html

Immunogenicity and clinical efficacy of 20-valent ... Immunogenicity and clinical efficacy of 20-valent pneumococcal conjugate vaccine (PCV20) in lymphoma survivors after treatment with anti-CD20 therapy.

5. cdc.gov cdc.gov/acip/grade/pneumo-PCV20-age-based.html

GRADE: 20-valent pneumococcal conjugate vaccine ... A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 and PCV20 among age groups for which the ...

6. prevnar20.com prevnar20.com/

PREVNAR 20® (Pneumococcal 20-Valent Conjugate Vaccine ... IMPORTANT SAFETY INFORMATION​​ Prevnar 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria ...

7. adult.prevnar20.com adult.prevnar20.com/safetyandsideeffects

Safety & Side Effects Learn about the safety risks, benefits and possible side effects of PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine), a one-dose adult vaccine.

8. cdc.gov cdc.gov/acip/grade/pneumo-PCV20-risk-based.html

20-valent pneumococcal conjugate vaccine (PCV20) for ... A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 and PCV20 among age ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973709/

Post‑licensure Safety Surveillance of 20‑Valent ... The VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events).