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Trial record 4 of 470 for:    Shingles

Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

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ClinicalTrials.gov Identifier: NCT01331161
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Shingles
Intervention Biological: ZOSTAVAX
Enrollment 77

Recruitment Details Subjects were recruited from Atlanta and Denver from July 2011 until March 2012 using flyers
Pre-assignment Details  
Arm/Group Title Older Group Younger Group
Hide Arm/Group Description

Participants between the ages of 60-79

ZOSTAVAX: shingles vaccine, one dose

Participants between the ages of 25-40

ZOSTAVAX: shingles vaccine, one dose

Period Title: Overall Study
Started 44 33
Completed 43 31
Not Completed 1 2
Reason Not Completed
Physician Decision             1             0
Lost to Follow-up             0             1
Pregnancy             0             1
Arm/Group Title Age 60-79 Years Age 25-40 Years Total
Hide Arm/Group Description Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously. Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously. Total of all reporting groups
Overall Number of Baseline Participants 44 33 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 33 participants 77 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  45.5%
33
 100.0%
53
  68.8%
>=65 years
24
  54.5%
0
   0.0%
24
  31.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants 33 participants 77 participants
68
(60 to 77)
33
(25 to 40)
61
(25 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 33 participants 77 participants
Female
25
  56.8%
23
  69.7%
48
  62.3%
Male
19
  43.2%
10
  30.3%
29
  37.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 33 participants 77 participants
44 33 77
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 33 participants 77 participants
Hispanic 3 3 6
Non hispanic 41 30 71
1.Primary Outcome
Title Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX
Hide Description The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants with immunoglobulin gene responses that correlated with adaptive immune responses
Arm/Group Title Participants 60-79 Years Participants 25-40 Years of Age
Hide Arm/Group Description:
participants who received one dose of vaccine
participants with one dose of vaccine
Overall Number of Participants Analyzed 44 33
Measure Type: Number
Unit of Measure: participants
44 33
2.Secondary Outcome
Title The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX
Hide Description The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with both T and B cell responses to vaccine
Arm/Group Title Age 60-79 Years Age 25-40 Years
Hide Arm/Group Description:
Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
Overall Number of Participants Analyzed 44 33
Measure Type: Number
Unit of Measure: participants
23 27
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Group Younger Group
Hide Arm/Group Description

Participants between the ages of 60-79

ZOSTAVAX: shingles vaccine, one dose

Participants between the ages of 25-40

ZOSTAVAX: shingles vaccine, one dose

All-Cause Mortality
Older Group Younger Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Older Group Younger Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/44 (4.55%)      0/33 (0.00%)    
Endocrine disorders     
Hyponatremia * [1]  1/44 (2.27%)  1 0/33 (0.00%)  0
Reproductive system and breast disorders     
Breast Cancer * [2]  1/44 (2.27%)  1 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
resulted in hospitalization- unrelated to study product
[2]
Breast cancer unrelated to study product
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Older Group Younger Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/44 (29.55%)      3/33 (9.09%)    
Infections and infestations     
Cold symptoms * [1]  3/44 (6.82%)  3 2/33 (6.06%)  2
Skin and subcutaneous tissue disorders     
Local Injection site reactions  [2]  6/44 (13.64%)  6 0/33 (0.00%)  0
Bruise at blood draw site  [3]  4/44 (9.09%)  4 1/33 (3.03%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
None related to study product- severity varied between 1 to 3 - all resolved
[2]
All were attributed as related to study product- severity was between 1 and 2- all resolved
[3]
realted to phlebotomy intervention- all resolved
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: Nadine Rouphael, MD
Organization: Emory University
Phone: 404-712-1435
Responsible Party: Nadine Rouphael, Emory University
ClinicalTrials.gov Identifier: NCT01331161     History of Changes
Other Study ID Numbers: IRB00050285
U19AI090023 ( U.S. NIH Grant/Contract )
HIPCVAX005 ( Other Identifier: Other )
First Submitted: April 6, 2011
First Posted: April 7, 2011
Results First Submitted: January 19, 2016
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016