NCT03771157

Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors

Completed EARLY_PHASE1 Results posted Last updated 15 March 2024

What this trial tests

EARLY_PHASE1 trial testing Shingrix vaccine in Chronic Lymphocytic Leukemia (CLL) in 33 participants. Completed in 3 August 2022.

Timeline

1 February 2019

Primary endpoint
1 September 2020

3 August 2022

Quick facts

Lead sponsor	University of Rochester
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	33
Start date	1 February 2019
Primary completion	1 September 2020
Estimated completion	3 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Shingrix vaccine — full drug profile →

Conditions studied

• Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →
• Waldenstrom Macroglobulinemia (WM) — all drugs for Waldenstrom Macroglobulinemia (WM) →

Sponsor

University of Rochester

Who can join

50 and older, any sex, with Chronic Lymphocytic Leukemia (CLL) or Waldenstrom Macroglobulinemia (WM). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration Primary · 4 weeks following the second vaccination, at approximately 3 months

Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects

Group	Value	95% CI
Shingrix Vaccine	24

Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration Secondary · 4 weeks following the second vaccination, at approximately 3 months

Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 4 weeks after the second vaccine administration.

Group	Value	95% CI
Shingrix Vaccine	26

Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration Secondary · 2 years following second vaccination, approximately 26 months from day 1

Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects

Group	Value	95% CI
Shingrix Vaccine	13

Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration Secondary · 2 years following second vaccination, approximately 26 months from day 1

Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 2 years after the second vaccine administration.

Group	Value	95% CI
Shingrix Vaccine	17

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from day one to four weeks after the second vaccine administration, up to approximately 3 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Shingrix Vaccine

Serious: 1/32 (3%)

Deaths: 0/32

Serious adverse events (1 terms)

Reaction	System	Shingrix Vaccine
Atrial fibrillation	Cardiac disorders	—

Most-reported serious reactions: Atrial fibrillation.

Data from ClinicalTrials.gov NCT03771157 adverse events section.

Sponsor's own description

The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Targeting immunosenescence for improved tumor immunotherapy.
   Liu Z, Zuo L, Zhou Z, Liu S, et al · · 2024 · cited 16× · PMID 39473905 · DOI 10.1002/mco2.777