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Cancer Vaccine

Pneumonia Vaccines for CLL

Phase 2
Recruiting
Led By Daniel Ermann, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =< 12 months prior to registration.
NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to the 2018 International Workshop on CLL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post ppsv23 vaccination
Awards & highlights

Study Summary

This trial is testing whether two different pneumococcal vaccines, given as a series, can help prevent pneumococcal infections in patients with chronic lymphocytic leukemia.

Who is the study for?
This trial is for adults aged 18+ with chronic lymphocytic leukemia who haven't had prior CLL treatment, or those treated with venetoclax for at least a year. Participants should not have used immunosuppressants recently, except certain steroids, and mustn't have had specific pneumonia vaccines in the last five years.Check my eligibility
What is being tested?
The PROTECT CLL Trial is testing if a series of two pneumococcal vaccines (PCV20 and PPSV23) can effectively stimulate an immune response to prevent infections in patients with chronic lymphocytic leukemia.See study design
What are the potential side effects?
Potential side effects from PCV20 and PPSV23 may include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or rash. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with venetoclax for at least a year and my last dose was within the last 12 months.
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I have been diagnosed with CLL or SLL as per the 2018 guidelines.
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I have never received treatment for chronic lymphocytic leukemia.
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I have been diagnosed with CLL or SLL as per the 2018 guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post ppsv23 vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post ppsv23 vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who achieve the protocol defined change in antibody titers
Secondary outcome measures
Proportion of patients who have a two-fold increase in antibody titers to an individual serotype vaccination
Proportion of patients who have a two-fold increase of immunoglobulin levels
Proportion of patients who maintain adequate immune response
+1 more
Other outcome measures
Number of patients that contract pneumonia
Proportion of venetoclax treated chronic lymphocytic leukemia (CLL) patients who achieve a two-fold increase in antibody titers

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (PCV20, PPPSV23)Experimental Treatment3 Interventions
Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (PCV20, PPSV23)Experimental Treatment3 Interventions
Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pneumococcal 20-valent Conjugate Vaccine
2022
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,629 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,794 Total Patients Enrolled
Daniel Ermann, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Media Library

Pneumococcal 13-valent Conjugate Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05183854 — Phase 2
Chronic Lymphocytic Leukemia Clinical Trial 2023: Pneumococcal 13-valent Conjugate Vaccine Highlights & Side Effects. Trial Name: NCT05183854 — Phase 2
Pneumococcal 13-valent Conjugate Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05183854 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Arm II (PCV20, PPPSV23), Arm I (PCV20, PPSV23)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Pneumococcal Polyvalent Vaccine been certified by the FDA?

"Our team at Power judged the safety of Pneumococcal Polyvalent Vaccine to be a 2 on account of it being Phase 2. This means that while there is data confirming its security, there are no studies proving efficacy yet."

Answered by AI

Are there any available openings for participation in this medical experiment?

"Affirmative. As evidenced by clinicaltrials.gov, this medical study is actively enlisting participants and was initially announced on the 7th of January 2022; with a later update being made to it on the 3rd of May 2022. 60 patients are required for this single-site trial."

Answered by AI

What is the primary objective of this clinical research endeavor?

"The principal aim of this medical trial, which will be gauged at 30 and 90 days after PCV13 vaccination is to assess the proportion of participants who demonstrate a change in antibody titers as indicated by protocol. Secondary targets include: assessing the ratio of subjects who retain an adequate immune response (as two-fold increase in serum antibodies from baseline within 6/12 S. pneumonia serotypes) over five years; ascertaining the portion of individuals with double antibody titer rise for each individual serotype post PPCV13 inoculation; and determining what fraction have 2x immunoglobulin levels from outset and do not develop"

Answered by AI

What is the upper capacity of participants enrolled in this experiment?

"Affirmative. Clinicaltrials.gov contains evidence that this investigation is still enrolling subjects, having been initially posted on July 1st of 2022 and last amended on May 3rd, 2022. Sixty individuals are requested to participate at a single research site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
2022. "Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05183854.
All > Cll > Chronic Lymphocytic Leukemia
~13 spots leftby Jan 2025
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