Trial Outcomes & Findings for Effects of Chronic Viral Infection on Immune Response to Zoster Vaccination (NCT NCT02590068)
NCT ID: NCT02590068
Last Updated: 2019-12-18
Results Overview
Serum zoster antibody level would be measured by gpELISA expressed in (units/mL)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
18 months
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Hepatitis C Infected Volunteers
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
Healthy Volunteers
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
14
|
|
Overall Study
COMPLETED
|
0
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Chronic Viral Infection on Immune Response to Zoster Vaccination
Baseline characteristics by cohort
| Measure |
Hepatitis C Infected Volunteers
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
Healthy Volunteers
n=14 Participants
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Samples were collected but none were tested for antibody levels
Serum zoster antibody level would be measured by gpELISA expressed in (units/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Samples were collected and cryopreserved. RNA was collected for these samples and batched, but the RNA-Seq (for RNA expression measurements) was not run. The samples wee not analyzed and no assays were performed for this protocol.
Interferon stimulated gene (ISG) expression in PBMC will be expressed as fold-change (FCH) above baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Samples were not analyzed and no assays were performed for this protocol.
Serum biomarkers of immune activation will be measured and expressed in percentage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Samples were not analyzed and no assays were performed for this protocol.
Responder cell frequency: VZV specific CD4+ T cells post-vaccination (expressed in %)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Samples were not analyzed and no assays were performed for this protocol.
Interferon-gamma response: by ELIspot expressed as number of spot-forming cells per million PBMCs
Outcome measures
Outcome data not reported
Adverse Events
Hepatitis C Infected Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hepatitis C Infected Volunteers
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
Healthy Volunteers
n=14 participants at risk
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
|---|---|---|
|
Cardiac disorders
Dyspnea
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
|
Cardiac disorders
Chest Pain
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
Other adverse events
| Measure |
Hepatitis C Infected Volunteers
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
Healthy Volunteers
n=14 participants at risk
Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers
Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
|
|---|---|---|
|
Blood and lymphatic system disorders
Mild Anemia
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
|
Musculoskeletal and connective tissue disorders
Mild Back Pain
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
|
Gastrointestinal disorders
Dental Filling Fell Out
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
|
General disorders
Lightheadedness
|
—
0/0 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
7.1%
1/14 • Number of events 1 • Up to 22 months
The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
|
Additional Information
Dr. Aileen O'Connell, Laboratory Manager
The Rockefeller University
Phone: 212-327-7047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place