Immune response to Shingrix vaccination in patients with chronic lymphocytic leukemia or Waldenstrom macroglobulinemia while undergoing treatment with BTK inhibitors
| ISRCTN | ISRCTN78423540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78423540 |
| ClinicalTrials.gov number | NCT03771157 |
| Secondary identifying numbers | RSRB00003228 |
- Submission date
- 15/11/2023
- Registration date
- 16/11/2023
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The blood cell cancers chronic lymphocytic leukemia (CLL) and Waldenstrom macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Shingles is a viral infection that causes a painful rash. Although a recently FDA-approved herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated the vaccine response in patients while on treatment with single-agent BTK inhibitors, the current standard therapy for this group. The aim of this study is to evaluate the immune response, through a blood test, to the Shingrix vaccine in these patients.
Who can participate?
Patients with CLL or WM who are at least 50 years old and undergoing first-line treatment with a BTK inhibitor.
What does the study involve?
Participants will receive 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 about 2 months after the first dose. Blood samples will be collected before the first dose of vaccine, about 4 weeks and 24 months after the second dose of vaccine.
What are the possible benefits and risks of participating?
Potential benefits are getting an FDA-approved zoster vaccine. Potential risks associated with blood draws include lightheadedness, bruising at the site of the needle stick and infection. Common side effects of the Shingrix vaccine include pain, redness and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach.
Where is the study run from?
University of Rochester (USA)
When is the study starting and how long is it expected to run for?
June 2018 to August 2022
Who is funding the study?
1. University of Rochester (USA)
2. GlaxoSmithKline Biologicals (Belgium)
Who is the main contact?
Dr Michael Brady, Michael_Brady@urmc.rochester.edu
Contact information
Public, Scientific
Wilmot Cancer Institute
601 Elmwood Ave
Rochester
14642
United States of America
| Phone | +1 (0)585 276 3203 |
|---|---|
| michael_brady@urmc.rochester.edu |
Principal Investigator
Wilmot Cancer Institute
601 Elmwood Ave
Rochester
14642
United States of America
| Phone | +1 (0)585 276 3203 |
|---|---|
| jonathan_friedberg@urmc.rochester.edu |
Study information
| Study design | Single-center interventional one-arm pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Serologic response to a new recombinant, adjuvanted herpes zoster vaccine in patients with chronic lymphocytic leukemia and Waldenstrom macroglobulinemia treated with first-line BTK inhibitors |
| Study objectives | Patients with chronic lymphocytic leukemia (CLL) or Waldenstrom macroglobulinemia (WM) undergoing first-line treatment with BTK inhibitors will elicit short-term and long-term immune response to the Shingrix varicella zoster vaccine. |
| Ethics approval(s) |
Approved 03/01/2019, Research Subjects Review Board (601 Elmwood Ave, Rochester, 14642, United States of America; +1 (0)585 273 4576; michelle_giglio@urmc.rochester.edu), ref: RSRB00003228 |
| Health condition(s) or problem(s) studied | Chronic lymphocytic leukemia or Waldenstrom macroglobulinemia |
| Intervention | Participants will receive 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 about 2 months after the first dose. Blood samples will be collected before the first dose of vaccine, about 4 weeks and 24 months after the second dose of vaccine. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Immunological Response |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Recombinant Varicella Zoster Glycoprotein E (Shingrix) |
| Primary outcome measure | Vaccine response at 4 weeks post-vaccination, as determined by serum antibody levels to the varicella virus glycoprotein E subunit (anti-gE) measured using ELISA |
| Secondary outcome measures | Vaccine response at 24 months post-vaccination, as determined by serum antibody levels to the varicella virus glycoprotein E subunit (anti-gE) measured using ELISA |
| Overall study start date | 20/06/2018 |
| Completion date | 03/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 33 |
| Total final enrolment | 32 |
| Key inclusion criteria | 1. Patients diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström macroglobulinemia (WM) 2. 50 years of age or older 3. Receiving first-line treatment with BTK inhibitor for at least 3 months; prior treatment with single-agent rituximab is permitted if the last dose was administered more than 1 year ago 4. Have at least a 1-year life expectancy 5. Have a history of varicella (chickenpox) OR lived in the US or any endemic country for >30 years |
| Key exclusion criteria | 1. Known hypersensitivity to a vaccine component 2. Herpes zoster reactivation within the past year 3. 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 4. 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 5. Are unable to give informed consent; 6. An absolute lymphocyte count greater than 20,000 x 10e9/L 7. Receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor 8. Rituximab treatment less than one year prior to study start 9. Prior chemotherapy |
| Date of first enrolment | 01/02/2019 |
| Date of final enrolment | 18/06/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Rochester
14642
United States of America
Sponsor information
University/education
Wilmot Cancer Institute
601 Elmwood Ave
Rochester
14642
United States of America
| Phone | +1 (0)585 275 4911 |
|---|---|
| Brian_Martin@urmc.rochester.edu | |
| Website | https://www.rochester.edu |
"ROR" |
https://ror.org/022kthw22 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- U of R, U of Rochester, Universitas Rocestriensis, UR
- Location
- United States of America
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- GSK Belgium, GlaxoSmithKline Biologicals SA, GlaxoSmithKline Biologicals SAS, GlaxoSmithKline (GSK) Biologicals, GSK Biologicals, GSK
- Location
- Belgium
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Study results were published in 2023. |
| IPD sharing plan | Data generated from this study will be available upon reasonable request from Dr Michael Brady (michael_brady@urmc.rochester.edu). Summary-level participant demographic data will be shared upon request, individual participant demographic data will not be shared due to the limited number of participants. Raw ELISA data collected from samples at baseline, 4 weeks and 24 months post-vaccination with associated disease type will be shared. Data are available now. All participants were consented prior to study activities. All data is anonymous, patient identifiable information will not be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/07/2023 | 16/11/2023 | Yes | No | |
| Basic results | 17/11/2023 | No | No |
Additional files
Editorial Notes
17/11/2023: Basic results added.
16/11/2023: Study's existence confirmed by the University of Rochester.
