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

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

  Hide Participant Flow

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

  Hide Baseline Characteristics

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

  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 ]

  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

  Show Serious Adverse Events

  Other Adverse Events

  Show Other Adverse Events

  Limitations and Caveats

  Hide Limitations and Caveats

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
No text entered.

  More Information

  Hide More Information

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:	February 17, 2016