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Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds

Primary Purpose

Shingles, Herpes Zoster

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

About this trial

This is an interventional basic science trial for Shingles focused on measuring Shingles vaccine, Immune response, Zoster vaccine

Eligibility Criteria

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

Inclusion Criteria:

  • History of varicella or residence int he US for 30 years
  • For Arms C and D - prior live zoster vaccine at least 5 years previously
  • For Arms A and B - Age 50-59 or 70-85
  • For Arms C and D - Age 70-85
  • For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine

Exclusion Criteria:

  • History of herpes zoster
  • For Arms A and B - prior live zoster vaccine
  • Immune compromising illness or therapies or chronic illness
  • Allergy to previous herpes zoster vaccine
  • Other investigational drugs or vaccines within the past 6 months before the study and until last visit
  • Blood products for 3 months prior to or planned during the study
  • Concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination.
  • Vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine.
  • Pregnancy or breast-feeding
  • Current drug addiction or alcoholism.

Sites / Locations

  • Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A - Live zoster vaccine

B - recombinant zoster vaccine

C - Live zoster vaccine

D - recombinant zoster vaccine

Arm Description

No previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous)

No previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular)

One previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous)

One previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular)

Outcomes

Primary Outcome Measures

Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number

Secondary Outcome Measures

Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)

Full Information

First Posted
April 11, 2014
Last Updated
July 7, 2020
Sponsor
University of Colorado, Denver
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02114333
Brief Title
Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
Official Title
A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the Glaxo Smith Kline (GSK) Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.
Detailed Description
160 people from the Denver area will participate. Duration is up to 5 years with 10-12 visits in that period. Subjects are randomized into one of 4 arms to receive either Zostavax or HZ/su. In this single blind study all subjects receive 2 injections: one at the first visit (Day 0) and the second at Day 60. HZ/su subjects will receive vaccine at both visits; Zostavax subjects will receive vaccine at the first visit and a placebo at the Day 60 visit. Blood is collected from all subjects at most visits. Some subjects spit into a tube for saliva collection. A urine sample is collected prior to vaccination if subject is a woman of childbearing potential. Subjects are asked to complete a diary to record any reactions in the 30 days after each injection. The Day 90 visit is the last one until the annual visits for blood draws begin at Day 365. Some subjects are also seen at Year 2 and Year 4; all subjects are seen at Year 5 for blood draw.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles, Herpes Zoster
Keywords
Shingles vaccine, Immune response, Zoster vaccine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Live zoster vaccine
Arm Type
Active Comparator
Arm Description
No previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous)
Arm Title
B - recombinant zoster vaccine
Arm Type
Active Comparator
Arm Description
No previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular)
Arm Title
C - Live zoster vaccine
Arm Type
Active Comparator
Arm Description
One previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous)
Arm Title
D - recombinant zoster vaccine
Arm Type
Active Comparator
Arm Description
One previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular)
Intervention Type
Biological
Intervention Name(s)
Zostavax
Intervention Description
0.65ml, subcutaneous
Intervention Type
Biological
Intervention Name(s)
HZ/su vaccine
Other Intervention Name(s)
Recombinant vaccine
Intervention Description
0.5ml, intramuscular
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline
Intervention Description
0.65ml, subcutaneous
Primary Outcome Measure Information:
Title
Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number
Time Frame
Measured up to Day 730
Secondary Outcome Measure Information:
Title
Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
Time Frame
Measured up to Day 730
Other Pre-specified Outcome Measures:
Title
Evaluation of Unsolicited adverse events
Time Frame
Within 30 days of each vaccination

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: History of varicella or residence int he US for 30 years For Arms C and D - prior live zoster vaccine at least 5 years previously For Arms A and B - Age 50-59 or 70-85 For Arms C and D - Age 70-85 For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine Exclusion Criteria: History of herpes zoster For Arms A and B - prior live zoster vaccine Immune compromising illness or therapies or chronic illness Allergy to previous herpes zoster vaccine Other investigational drugs or vaccines within the past 6 months before the study and until last visit Blood products for 3 months prior to or planned during the study Concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination. Vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine. Pregnancy or breast-feeding Current drug addiction or alcoholism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron J Levin, M.D.
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34850039
Citation
Johnson MJ, Liu C, Ghosh D, Lang N, Levin MJ, Weinberg A. Cell-Mediated Immune Responses After Administration of the Live or the Recombinant Zoster Vaccine: 5-Year Persistence. J Infect Dis. 2022 Apr 19;225(8):1477-1481. doi: 10.1093/infdis/jiab580.
Results Reference
derived
PubMed Identifier
30247596
Citation
Weinberg A, Kroehl ME, Johnson MJ, Hammes A, Reinhold D, Lang N, Levin MJ. Comparative Immune Responses to Licensed Herpes Zoster Vaccines. J Infect Dis. 2018 Sep 22;218(suppl_2):S81-S87. doi: 10.1093/infdis/jiy383.
Results Reference
derived

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Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds

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