Trial Outcomes & Findings for Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly (NCT NCT01331161)

NCT ID: NCT01331161

Last Updated: 2016-02-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2016-02-17

Participant Flow

Subjects were recruited from Atlanta and Denver from July 2011 until March 2012 using flyers

Participant milestones

Measure	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
Overall Study STARTED	44	33
Overall Study COMPLETED	43	31
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	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
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Pregnancy	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Age 60-79 Years n=44 Participants Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.	Age 25-40 Years n=33 Participants Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	33 Participants n=4 Participants	53 Participants n=27 Participants
Age, Categorical >=65 years	24 Participants n=93 Participants	0 Participants n=4 Participants	24 Participants n=27 Participants
Age, Continuous	68 years n=93 Participants	33 years n=4 Participants	61 years n=27 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	23 Participants n=4 Participants	48 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	10 Participants n=4 Participants	29 Participants n=27 Participants
Region of Enrollment United States	44 participants n=93 Participants	33 participants n=4 Participants	77 participants n=27 Participants
Ethnicity Hispanic	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity Non hispanic	41 Participants n=93 Participants	30 Participants n=4 Participants	71 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 years

Population: participants with immunoglobulin gene responses that correlated with adaptive immune responses

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

Outcome measures

Measure	Participants 60-79 Years n=44 Participants participants who received one dose of vaccine	Participants 25-40 Years of Age n=33 Participants participants with one dose of vaccine
Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX	44 participants	33 participants

SECONDARY outcome

Timeframe: 2 years

Population: Participants with both T and B cell responses to vaccine

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

Outcome measures

Measure	Participants 60-79 Years n=44 Participants participants who received one dose of vaccine	Participants 25-40 Years of Age n=33 Participants participants with one dose of vaccine
The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX	23 participants	27 participants

Adverse Events

Older Group

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Younger Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Older Group n=44 participants at risk Participants between the ages of 60-79 ZOSTAVAX: shingles vaccine, one dose	Younger Group n=33 participants at risk Participants between the ages of 25-40 ZOSTAVAX: shingles vaccine, one dose
Endocrine disorders Hyponatremia	2.3% 1/44 • Number of events 1	0.00% 0/33
Reproductive system and breast disorders Breast Cancer	2.3% 1/44 • Number of events 1	0.00% 0/33

Other adverse events

Measure	Older Group n=44 participants at risk Participants between the ages of 60-79 ZOSTAVAX: shingles vaccine, one dose	Younger Group n=33 participants at risk Participants between the ages of 25-40 ZOSTAVAX: shingles vaccine, one dose
Skin and subcutaneous tissue disorders Local Injection site reactions	13.6% 6/44 • Number of events 6	0.00% 0/33
Skin and subcutaneous tissue disorders Bruise at blood draw site	9.1% 4/44 • Number of events 4	3.0% 1/33 • Number of events 1
Infections and infestations Cold symptoms	6.8% 3/44 • Number of events 3	6.1% 2/33 • Number of events 2

Additional Information

Nadine Rouphael, MD

Emory University

Phone: 404-712-1435

Email: nroupha@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place