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CompletedNCT02624375Updated Dec 5, 2019Results posted

Immune Response to Shingles Vaccination

A Phase 4 interventional study of Zoster Vaccine Live in Shingles, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by University of Washington · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
70 Years and older
Sex
All
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Study summary

The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).

Read the detailed description

Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.

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Conditions studied

  • Shingles

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In context

Herpes Zoster

360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.

This study's enrollment of 10 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 70 years of age or older.
  • History of chickenpox.

Exclusion criteria

Exclusion Criteria

  • Previous vaccination with Zostavax or with the chickenpox vaccine.
  • History of ever having had shingles.
  • Been in close contact with a person who had chickenpox or shingles in the past 5 years.
  • VZV seronegative
  • Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
  • HIV seropositive.
  • Hepatitis C infection or active Hepatitis B infection.
  • History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
  • Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
  • Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
  • Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
  • Donated blood in the past 8 weeks or planning to donate blood during the study
  • Weighs less than 110 lbs
  • Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Additional exclusions for optional skin biopsy:

  1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
  2. History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
  3. History of keloid formation or excessive scarring
  4. History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
  5. Allergy to lidocaine, silver nitrate, or mupirocin.
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    10 persons over 70 years of age that received Zostavax

    10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)

    Drug: Zoster Vaccine Live

Interventions

  • DrugZoster Vaccine Live

    Also known as: ZOSTAVAX

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What researchers measure

Primary outcomes

  1. Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood

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

    Time frame: 6 months

  2. Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin

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

    Time frame: 4 weeks

Secondary outcomes

  1. Number of Participants With Adverse Events Due to Zostavax

    To measure the occurrence of adverse events after Zostavax.

    Time frame: 6 months

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Results

Posted Dec 5, 2019

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 flow — Overall Study
MilestonePersons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Started10
Completed10
Not completed0

Outcome measures

PrimaryPercentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood

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

Time frame:
6 months
Reported as:
Median · percentage of CD4 T cells
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
percentage of CD4 T cellsPersons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood0.02 (0 to 0.07)
PrimaryPercentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin

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

Time frame:
4 weeks
Reported as:
Median · Percentage of CD4 T cells
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
Percentage of CD4 T cellsPersons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin0 (0 to 0.05)
SecondaryNumber of Participants With Adverse Events Due to Zostavax

To measure the occurrence of adverse events after Zostavax.

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events Due to Zostavax
ParticipantsPersons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Number of Participants With Adverse Events Due to Zostavax0

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Person 70 and over receiving Zostavax

Age, Continuous
Age, Continuous(years)Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Median74.5 (70 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Female7
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Hispanic or Latino0
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White9
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
United States10
no history of shingles or shingles vaccination
no history of shingles or shingles vaccination(Participants)Persons 70 and Over Receiving Zostavax (Zoster Vaccine Live)
Count of participants10
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Study locations

1 site
  • University of Washington Virology Research Clinic
    Seattle, Washington 98104, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 16, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02624375
Lead sponsor
University of Washington
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Christine Johnston (Associate Professor, University of Washington) — Principal investigator
First posted
Dec 8, 2015
Start date
Feb 2016
Primary completion
Nov 2019
Completion
Nov 2019
Results posted
Dec 5, 2019
Last update
Dec 5, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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