Pneumococcal 13-valent Conjugate Vaccine for Leukemia, Lymphoid

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Leukemia, Lymphoid+4 More
Pneumococcal 13-valent Conjugate Vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial compares the effect of initial vaccination (PCV13 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.

Eligible Conditions

  • Leukemia, Lymphoid
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At 1 and 3 months

Month 3
Proportion of patients with local and/or general reaction
At 2 years
Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)
At 5 years
Number of pneumococcal infections
Proportion of patients with anti-pneumococcal immunogenicity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B (5 year booster)
1 of 2
Arm A (yearly booster)
1 of 2
Active Control
Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Pneumococcal 13-valent Conjugate Vaccine · No Placebo Group · Phase 2

Arm A (yearly booster)Experimental Group · 2 Interventions: Pneumococcal Polyvalent Vaccine, Pneumococcal 13-valent Conjugate Vaccine · Intervention Types: Biological, Biological
Arm B (5 year booster)ActiveComparator Group · 2 Interventions: Pneumococcal Polyvalent Vaccine, Pneumococcal 13-valent Conjugate Vaccine · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pneumococcal 13-valent Conjugate Vaccine
2018
Completed Phase 3
~530

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 and 3 months
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
32 TrialsResearching Leukemia, Lymphoid
203 CompletedClinical Trials

Who is running the clinical trial?

Seema BhatLead Sponsor
Seema A Bhat, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms.
You are a treatment naive CLL/SLL patient.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.