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Virus Therapy

Zoster Vaccine Recombinant, Adjuvanted for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Christopher MT Pleyer, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

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 6 months after the first vaccine administration

Awards & highlights

Study Summary

This trial is testing a new shingles vaccine to see if it is safe and effective for people with chronic lymphocytic leukemia.

Eligible Conditions

Chronic Lymphocytic Leukemia
Shingrix Vaccine Response Rates
Safety and Tolerability
Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after the first vaccine administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after the first vaccine administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after the first vaccine administration 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 Varicella Zoster Virus (VZV) Seroprotective Titer

Secondary outcome measures

Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.

Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.

Side effects data

From 2023 Phase 2 trial • 116 Patients • NCT03702231

96%

Pain

54%

Fatigue

54%

Injection site reaction

46%

Myalgia

32%

Flu like symptoms

32%

Headache

14%

Chills

Edema limbs

100%

80%

60%

40%

20%

Study treatment Arm

Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib

Chronic Lymphocytic Leukemia Patients That Are Treatment Naive

Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib

Trial Design

3Treatment groups

Experimental Treatment

Group I: Chronic Lymphocytic Leukemia Patients That Are Treatment NaiveExperimental Treatment1 Intervention

Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.

Group II: Chronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibExperimental Treatment1 Intervention

Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.

Group III: Chronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibExperimental Treatment1 Intervention

Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zoster Vaccine Recombinant, Adjuvanted

2018

Completed Phase 2

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor

3,836 Previous Clinical Trials

47,310,996 Total Patients Enrolled

Christopher MT Pleyer, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

3 Previous Clinical Trials

653 Total Patients Enrolled

Frequently Asked Questions

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

Do the requirements for this experiment preclude elderly individuals?

"This trial is only open to patients that meet the age requirement of 18-99. There are 467 other trials available for those under 18 and 1318 for seniors."

Answered by AI

Has the FDA acknowledged Zoster Vaccine Recombinant, Adjuvanted as an effective medication?

"Zoster Vaccine Recombinant, Adjuvanted has only been proven safe in clinical trials and not effective. Therefore, it receives a score of 2."

Answered by AI

How can I sign up for this opportunity to test a new treatment?

"This leukemia trial has116 total slots open to patients that are between 18 and 99 years old."

Answered by AI

Are there any available openings for new participants in this clinical trial?

"This particular clinical trial, which was first advertised on December 7th 2018, is no longer recruiting patients. Although, there are 1631 other trials with open enrolment at this time."

Answered by AI

Are there any other similar investigations to this one involving the use of Zoster Vaccine Recombinant, Adjuvanted?

"There are currently 17 different ongoing clinical trials studying the efficacy of Zoster Vaccine Recombinant, Adjuvanted. Of those, 4 have progressed to Phase 3 testing. Most of the research being conducted is based in Shanghai, but there are 208 total locations running these trials."

Answered by AI

Does this clinical trial offer anything unique compared to others of its kind?

"There are many ongoing trials for this medication, with 17 taking place in 23 countries. The first trial was conducted in 2014 by Bristol-Myers Squibb. This initial study had 130 participants and completed its second stage of drug approval. In the years since 2014, there have been a total of 56 completed trials."

Answered by AI