Trial Outcomes & Findings for Zoster Vaccine Response in the Frail Elderly (NCT NCT01328548)

Results Overview

As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = \>50 spots and a low baseline response will be ELISPOT = \<10 spots.

Recruitment status

COMPLETED

Target enrollment

241 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Nursing Home Vaccine Group Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Overall Study STARTED	191	50
Overall Study COMPLETED	187	50
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nursing Home Vaccine Group Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Overall Study Death	3	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Zoster Vaccine Response in the Frail Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nursing Home Vaccine Group n=191 Participants Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group n=50 Participants Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine	Total n=241 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	191 Participants n=5 Participants	35 Participants n=7 Participants	226 Participants n=5 Participants
Age, Continuous	89.0 Years STANDARD_DEVIATION 4.69 • n=5 Participants	67.3 Years STANDARD_DEVIATION 4.34 • n=7 Participants	84.5 Years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	154 Participants n=5 Participants	32 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	18 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Canada	191 Participants n=5 Participants	50 Participants n=7 Participants	241 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: IFN-gamma T cell ELISpot assay (sfu) against VZV taken prior to vaccination and 6 weeks post vaccination

As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = \>50 spots and a low baseline response will be ELISPOT = \<10 spots.

Outcome measures

Outcome measures
Measure	Nursing Home Vaccine Group n=187 Participants Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group n=50 Participants Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly Pre-vaccine IFN-gamma T cell ELISpot assay count	50.17 Spot Forming Units per 10^6 PBMC Standard Deviation 54.84	78.17 Spot Forming Units per 10^6 PBMC Standard Deviation 65.37
Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly Post- vaccine IFN-gamma T cell ELISpot assay count	83.22 Spot Forming Units per 10^6 PBMC Standard Deviation 72.56	120.56 Spot Forming Units per 10^6 PBMC Standard Deviation 76.87

PRIMARY outcome

Timeframe: Baseline

Population: Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.

Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.

Outcome measures

Outcome measures
Measure	Nursing Home Vaccine Group n=186 Participants Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio	3.06 T-cell ratio Standard Deviation 2.38	—

PRIMARY outcome

Timeframe: Baseline

Population: Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.

Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.

Outcome measures

Outcome measures
Measure	Nursing Home Vaccine Group n=186 Participants Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells	2.23 % of peripheral blood mononuclear cell Standard Deviation 1.00	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Data not collected.

Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Data not collected.

Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Genotyping was not conducted because of insufficient resources.

These will include Tolllike receptors, cytokines, chemokines, chemokine receptors, interferons and interferon receptors. Tolllike receptors: TLR1TLR9 Cytokines: ILI1A, ILI1B, IL1RN, IL4, IL5, IL12B, IL13, CSF2 Chemokines: CCL1CCL3, CCL3L1, CCL4CCL8, CCL11, CCL13, CCL15CCL28, CXCL1CXCL14, CXCL16, CX3CL1 Chemokine receptors: CCR1CCR10, CXCR1CXCR6, CX3CR1, XCR1XCR2 Interferons: IFNA1IFNA2, IFNA4IFNA8, IFNA10, IFNA13, IFNA14, IFNA16IFNA17, IFNA21, IFNB1, IFNB3, IFNG, IFNK, IFNW1 Interferon receptors: IFNAR1, IFNAR2, IFNGR1, IFNGR2

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.

Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.

Outcome measures

Outcome measures
Measure	Nursing Home Vaccine Group n=186 Participants Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency	65.24 % of peripheral blood mononuclear cell Standard Deviation 15.41	—

Adverse Events

Nursing Home Vaccine Group

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Community Control Vaccine Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nursing Home Vaccine Group n=191 participants at risk Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group n=50 participants at risk Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
General disorders Pre-existing fragile health and advanced age	0.52% 1/191 • Number of events 1	0.00% 0/50
Renal and urinary disorders Progressive renal failure	0.52% 1/191 • Number of events 1	0.00% 0/50
Nervous system disorders Advanced age and medical issues (Parkinson's disease)	0.52% 1/191 • Number of events 1	0.00% 0/50

Other adverse events

Other adverse events
Measure	Nursing Home Vaccine Group n=191 participants at risk Nursing home residents \>= 80 years vaccinated with the ZOSTAVAX zoster vaccine	Community Control Vaccine Group n=50 participants at risk Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
General disorders Cough	2.1% 4/191 • Number of events 4	0.00% 0/50
General disorders Fall	1.6% 3/191 • Number of events 3	0.00% 0/50
General disorders Lethargy	2.6% 5/191 • Number of events 5	0.00% 0/50
General disorders Emesis/Nausea	2.6% 5/191 • Number of events 5	0.00% 0/50
General disorders Pain/Soreness in arm	1.6% 3/191 • Number of events 3	4.0% 2/50 • Number of events 2
General disorders Redness/Swelling in arm	2.1% 4/191 • Number of events 4	18.0% 9/50 • Number of events 9
General disorders Headache	0.52% 1/191 • Number of events 1	2.0% 1/50 • Number of events 1

Additional Information

Dr. Mark Loeb

McMaster University

Phone: 905 515 9140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place