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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331161
First Posted: April 7, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nadine Rouphael, Emory University
Results First Submitted: January 19, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from Atlanta and Denver from July 2011 until March 2012 using flyers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Older Group

Participants between the ages of 60-79

ZOSTAVAX: shingles vaccine, one dose
Younger Group

Participants between the ages of 25-40

ZOSTAVAX: shingles vaccine, one dose

Participant Flow:   Overall Study
    Older Group   Younger Group
STARTED   44   33 
COMPLETED   43   31 
NOT COMPLETED   1   2 
Physician Decision                1                0 
Lost to Follow-up                0                1 
Pregnancy                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Age 60-79 Years Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
Age 25-40 Years Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
Total Total of all reporting groups

Baseline Measures
   Age 60-79 Years   Age 25-40 Years   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 44   33   77 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   20   33   53 
>=65 years   24   0   24 
Age 
[Units: Years]
Median (Full Range) 		 68 
 (60 to 77)  		 33 
 (25 to 40)  		 61 
 (25 to 77) 
Gender 
[Units: Participants]
 		     
Female   25   23   48 
Male   19   10   29 
Region of Enrollment 
[Units: Participants]
 		     
United States   44   33   77 
Ethnicity 
[Units: Participants]
 		     
Hispanic   3   3   6 
Non hispanic   41   30   71 


  Outcome Measures
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1.  Primary:   Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX   [ Time Frame: 2 years ]
  Show Outcome Measure 1

2.  Secondary:   The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX   [ Time Frame: 2 years ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: nroupha@emory.edu



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: October 12, 2017