Chronic Lymphocytic Leukemia (CLL)Early Phase 1NCT03771157
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
A Early Phase 1 study testing Shingrix vaccine in people with Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinemia (WM), run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Waldenstrom Macroglobulinemia (WM)
- What is being tested?
- Shingrix vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 3 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are at least 50 years of age;
- Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
- Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
- Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
- Have at least a one-year life expectancy;
- Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for > 30 years.
- Prior radiation therapy is allowed
Who cannot join
- They have a known hypersensitivity to a vaccine component;
- Had herpes zoster reactivation within the past year;
- Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
- Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
- Are unable to give informed consent;
- Have absolute lymphocyte counts greater than 20,000 X 109/L;
Show all 9Show fewer
- Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor;
- Had rituximab treatment within a year prior to study start;
- Had prior chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors - A Pilot Study
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.
Read the detailed description
Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them.
The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients.
The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM under first-line BTK inhibitors.
- Being tested
- Shingrix vaccine
- Keywords
- shingles vaccine (Shingrix), Chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia (WM), Pilot Study
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shingrix vaccineDrug
Also called Herpes Zoster Vaccine Recombinant, Adjuvanted
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.
| Study group | Role | What they receive |
|---|---|---|
| Shingrix shingles vaccine treatment | Experimental | 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. Receives: Drug: Shingrix vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
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
Measured: 4 weeks following the second vaccination, at approximately 3 months
Secondary outcomes (1)
Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration
Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 4 weeks after the second vaccine administration.
Measured: 4 weeks following the second vaccination, at approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Feb 2019
- Primary completion1 Sep 2020
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Jonathan Friedberg, University of Rochester
- Investigators
- Jonathan Friedberg, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771157
- Sponsor's protocol ID
- 00003112
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2018
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors - A Pilot Study
- ClinicalTrials.gov ID
- NCT03771157
- Acronym / sponsor ID
- 00003112
- Keywords
- shingles vaccine (Shingrix), Chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia (WM), Pilot Study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them.
The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients.
The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM under first-line BTK inhibitors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shingrix shingles vaccine treatment | Experimental | Drug: Shingrix vaccineOn 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- They are at least 50 years of age;
- Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
- Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
- Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
- Have at least a one-year life expectancy;
Key exclusion criteria (9 listed)
- They have a known hypersensitivity to a vaccine component;
- Had herpes zoster reactivation within the past year;
- Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
- Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
- Are unable to give informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shingrix vaccineAlso: Herpes Zoster Vaccine Recombinant, AdjuvantedOn 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. | Drug | Shingrix shingles vaccine treatment |
Primary outcome
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
Time frame: 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
1 secondary outcome
Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration
Time frame: 4 weeks following the second vaccination, at approximately 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Friedberg, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Shingrix vaccine in people with Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinemia (WM), run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration (time frame: 4 weeks following the second vaccination, at approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.