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T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020

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ClinicalTrials.gov Identifier: NCT01911065
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : March 3, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Herpes Zoster
Intervention Biological: Zostavax™
Enrollment 54

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Hide Arm/Group Description Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. 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).
Period Title: Overall Study
Started 45 9
Completed 45 9
Not Completed 0 0
Arm/Group Title Zostavax™ Vaccine Group Naturally-acquired VZV Immunity Total
Hide Arm/Group Description Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. 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 of all reporting groups
Overall Number of Baseline Participants 45 9 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 45 participants 9 participants 54 participants
40-49 Years Old
0
   0.0%
9
 100.0%
9
  16.7%
50 and above
45
 100.0%
0
   0.0%
45
  83.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 9 participants 54 participants
Female
21
  46.7%
7
  77.8%
28
  51.9%
Male
24
  53.3%
2
  22.2%
26
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 9 participants 54 participants
Hispanic or Latino
3
   6.7%
0
   0.0%
3
   5.6%
Not Hispanic or Latino
40
  88.9%
9
 100.0%
49
  90.7%
Unknown or Not Reported
2
   4.4%
0
   0.0%
2
   3.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 9 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
  22.2%
2
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
43
  95.6%
7
  77.8%
50
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   4.4%
0
   0.0%
2
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 9 participants 54 participants
45 9 54
1.Primary Outcome
Title Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV
Hide Description [Not Specified]
Time Frame Day 0 to Day 35
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Hide Arm/Group Description:
Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
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 Number of Participants Analyzed 45 9
Measure Type: Count of Participants
Unit of Measure: Participants
45
 100.0%
9
 100.0%
2.Secondary Outcome
Title Number of Participants With Related Adverse Events
Hide Description [Not Specified]
Time Frame 0 to 35 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Hide Arm/Group Description:
Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
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 Number of Participants Analyzed 45 9
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema at injection site greater 5 cm
5
  11.1%
0
   0.0%
No related AEs
40
  88.9%
9
 100.0%
3.Other Pre-specified Outcome
Title Identify Predictors That Correlate With a Rapid and Diverse T Cell Response.
Hide Description The 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.
Time Frame 0 to 14 Days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Hide Arm/Group Description Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection. 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).
All-Cause Mortality
Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zostavax™ Vaccine Group Naturally-acquired VZV Immunity
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/45 (6.67%)      0/9 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection  [1]  2/45 (4.44%)  2 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders     
Herpes zoster  [2]  1/45 (2.22%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Resolved without sequelae
[2]
Herpes zoster developed 1 day following immunization; lesion isolate sent to CDC and was wild-type (not vaccine strain), resolved after prolonged PHN despite prompt antiviral treatment. VAERS report filed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Cornelia Dekker
Organization: Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Responsible Party: Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier: NCT01911065     History of Changes
Other Study ID Numbers: SU-19385
1U19AI090019-01 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2013
First Posted: July 30, 2013
Results First Submitted: January 11, 2017
Results First Posted: March 3, 2017
Last Update Posted: April 21, 2017