Trial Outcomes & Findings for Immune Response to Shingles Vaccination (NCT NCT02624375)

NCT ID: NCT02624375

Last Updated: 2019-12-05

Results Overview

To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-12-05

Participant Flow

Recruitment occurred from September 2016 to January 2018. Recruitment was done by placing flyers at retirement homes and by contacting persons over 70 who had previously been enrolled in research studies including giving informed written consent to be re contacted for future studies.

Participant milestones

Measure	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Response to Shingles Vaccination

Baseline characteristics by cohort

Measure	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) n=10 Participants We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
Age, Continuous	74.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
no history of shingles or shingles vaccination	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 persons 70 and older who received Zostavax

To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood

Outcome measures

Measure	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) n=10 Participants We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood	0.02 percentage of CD4 T cells Interval 0.0 to 0.07

PRIMARY outcome

Timeframe: 4 weeks

To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax

Outcome measures

Measure	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) n=10 Participants We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin	0 Percentage of CD4 T cells Interval 0.0 to 0.05

SECONDARY outcome

Timeframe: 6 months

To measure the occurrence of adverse events after Zostavax.

Outcome measures

Measure	Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live) n=10 Participants We administered Zostavax at the FDA approved dose and route to an FDA-indication-approved population, namely healthy adults 70 and over. We administered vaccine to 10 persons as proposed in the protocol.
Number of Participants With Adverse Events Due to Zostavax	0 Participants

Adverse Events

Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Johnston, Associate Professor

University of Washington

Phone: 206 520 4340

Email: cjohnsto@uw.edu

Results disclosure agreements

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

Restriction type: LTE60