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

• 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: Emory University
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Age 60-79 Years	Age 25-40 Years	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Participants with both T and B cell responses to vaccine

Arm/Group Title	Age 60-79 Years	Age 25-40 Years
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Older Group		Younger Group
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	--/--		--/--
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
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

Limitations and Caveats

[Not Specified]

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
• EMail: nroupha@emory.edu

• Responsible Party: Nadine Rouphael, Emory University
• ClinicalTrials.gov Identifier: NCT01331161
• 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