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Shingrix vaccine for Chronic Lymphocytic Leukemia

Phase < 1
Waitlist Available
Led By Jonathan Friedberg, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks following the second vaccination, at approximately 3 months
Awards & highlights

Study Summary

This trial will test whether the Shingrix vaccine is effective in patients with CLL or Waldenström Macroglobulinemia who are taking first-line BTK inhibitors.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Waldenström's Macroglobulinemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks following the second vaccination, at approximately 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks following the second vaccination, at approximately 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
Secondary outcome measures
Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration
Other outcome measures
Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration
Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Shingrix shingles vaccine treatmentExperimental Treatment1 Intervention
On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shingrix vaccine
2019
Completed Early Phase 1
~40

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,751 Previous Clinical Trials
8,067,439 Total Patients Enrolled
University of RochesterLead Sponsor
837 Previous Clinical Trials
518,084 Total Patients Enrolled
Jonathan Friedberg, MDPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Jonathan Friedberg 2019. "Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03771157.
~5 spots leftby Apr 2025
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