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Persistence of Protection by Shingrix

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zostavax
Shingrix
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Herpes Zoster focused on measuring immunology

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 50-85
  • General good health
  • Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
  • ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
  • ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
  • ARM 3 ONLY: Have never received any shingles vaccination

Exclusion Criteria:

  • Prior history of herpes zoster (HZ)
  • Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.
  • Significant immune suppressive illness or therapy
  • Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.
  • Women of childbearing potential.
  • Pregnancy or breastfeeding.
  • Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.

Sites / Locations

  • Clinical Trials Center at University of Colorado Anschutz Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

ZVL >5 years previously

ZVL 6-12 months previously

No previous ZVL

SRX >5 years previously

Arm Description

Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.

Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.

Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.

Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.

Outcomes

Primary Outcome Measures

Magnitude of Varicella-Zoster Virus (VZV) DNAemia
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2019
Last Updated
June 2, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04169009
Brief Title
Persistence of Protection by Shingrix
Official Title
Persistence of Protection Conferred by Shingrix Against Herpes Zoster
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
immunology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZVL >5 years previously
Arm Type
Active Comparator
Arm Description
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Arm Title
ZVL 6-12 months previously
Arm Type
Active Comparator
Arm Description
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Arm Title
No previous ZVL
Arm Type
Active Comparator
Arm Description
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Arm Title
SRX >5 years previously
Arm Type
Active Comparator
Arm Description
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Intervention Type
Biological
Intervention Name(s)
Zostavax
Intervention Description
Intradermal injection of Zostavax
Intervention Type
Biological
Intervention Name(s)
Shingrix
Intervention Description
Given to subjects in Arm 4 who've never had a herpes zoster vaccine
Primary Outcome Measure Information:
Title
Magnitude of Varicella-Zoster Virus (VZV) DNAemia
Description
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
Time Frame
Until VZV DNA is undetectable in the blood, measured up to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 50-85 General good health Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment ARM 3 ONLY: Have never received any shingles vaccination Exclusion Criteria: Prior history of herpes zoster (HZ) Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration. Significant immune suppressive illness or therapy Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study. Women of childbearing potential. Pregnancy or breastfeeding. Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Weinberg, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Center at University of Colorado Anschutz Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Persistence of Protection by Shingrix

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