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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nadine Rouphael, Emory University
ClinicalTrials.gov Identifier:
NCT01331161
First received: April 6, 2011
Last updated: January 19, 2016
Last verified: January 2016
Results First Received: January 19, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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
  Show All Outcome Measures

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  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 ( US NIH Grant/Contract Award Number )
HIPCVAX005 ( Other Identifier: Other )
Study First Received: April 6, 2011
Results First Received: January 19, 2016
Last Updated: January 19, 2016
Health Authority: United States: Federal Government