Trial Outcomes & Findings for T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020 (NCT NCT01911065)
NCT ID: NCT01911065
Last Updated: 2023-12-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
54 participants
Primary outcome timeframe
Day 0 to Day 35
Results posted on
2023-12-18
Participant Flow
Participant milestones
| Measure |
Zostavax™ Vaccine Group
Participants \> 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
|
Naturally-acquired VZV Immunity
Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
9
|
|
Overall Study
COMPLETED
|
45
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
Baseline characteristics by cohort
| Measure |
Zostavax™ Vaccine Group
n=45 Participants
Participants \> 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
|
Naturally-acquired VZV Immunity
n=9 Participants
Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 40-49 Years Old
|
0 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Customized
Age · 50 and above
|
45 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=93 Participants
|
9 participants
n=4 Participants
|
54 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 35Outcome measures
| Measure |
Zostavax™ Vaccine Group
n=45 Participants
Participants \> 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
|
Naturally-acquired VZV Immunity
n=9 Participants
Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
|
|---|---|---|
|
Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV
|
45 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 0 to 35 DaysOutcome measures
| Measure |
Zostavax™ Vaccine Group
n=45 Participants
Participants \> 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
|
Naturally-acquired VZV Immunity
n=9 Participants
Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
|
|---|---|---|
|
Number of Participants With Related Adverse Events
Erythema at injection site greater 5 cm
|
5 Participants
|
0 Participants
|
|
Number of Participants With Related Adverse Events
No related AEs
|
40 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 14 DaysThe investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups.
Outcome measures
Outcome data not reported
Adverse Events
Zostavax™ Vaccine Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Naturally-acquired VZV Immunity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zostavax™ Vaccine Group
n=45 participants at risk
Participants \> 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
|
Naturally-acquired VZV Immunity
n=9 participants at risk
Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.4%
2/45 • Number of events 2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
Additional Information
Dr Cornelia Dekker
Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place