Trial Outcomes & Findings for Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors (NCT NCT03771157)
NCT ID: NCT03771157
Last Updated: 2024-03-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
33 participants
Primary outcome timeframe
4 weeks following the second vaccination, at approximately 3 months
Results posted on
2024-03-15
Participant Flow
Participant milestones
| Measure |
Shingrix Vaccine
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.
Shingrix vaccine: 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.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Baseline characteristics by cohort
| Measure |
Shingrix Vaccine
n=32 Participants
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. Antibody and cellular response to vaccination will be assessed at 4 weeks and 24 months after the second dose.
|
|---|---|
|
Age, Customized
50 to 65 years
|
12 Participants
n=99 Participants
|
|
Age, Customized
> 65 years
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeks following the second vaccination, at approximately 3 monthsVaccine 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
Outcome measures
| Measure |
Shingrix Vaccine
n=32 Participants
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. Antibody and cellular response to vaccination will be assessed at 4 weeks after the second dose.
|
|---|---|
|
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
|
24 Participants
|
SECONDARY outcome
Timeframe: 4 weeks following the second vaccination, at approximately 3 monthsCellular response, as determined by measuring VZgE-specific T-cell responses in blood, 4 weeks after the second vaccine administration.
Outcome measures
| Measure |
Shingrix Vaccine
n=32 Participants
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. Antibody and cellular response to vaccination will be assessed at 4 weeks after the second dose.
|
|---|---|
|
Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years following second vaccination, approximately 26 months from day 1Vaccine 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
Outcome measures
| Measure |
Shingrix Vaccine
n=31 Participants
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. Antibody and cellular response to vaccination will be assessed at 4 weeks after the second dose.
|
|---|---|
|
Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years following second vaccination, approximately 26 months from day 1Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 2 years after the second vaccine administration.
Outcome measures
| Measure |
Shingrix Vaccine
n=31 Participants
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. Antibody and cellular response to vaccination will be assessed at 4 weeks after the second dose.
|
|---|---|
|
Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration
|
17 Participants
|
Adverse Events
Shingrix Vaccine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Shingrix Vaccine
n=32 participants at risk
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. Antibody and cellular response to vaccination will be assessed at 4 weeks and 24 months after the second dose.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from day one to four weeks after the second vaccine administration, up to approximately 3 months.
Only adverse events grade 3 and greater will be collected. Adverse events were obtained through medical chart review and self-reporting by participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place