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

July 7, 2020 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A - Live zoster vaccine

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)
Biological: Zostavax
0.65ml, subcutaneous
Biological: Placebo
0.65ml, subcutaneous
Other Names:
  • normal saline
ACTIVE_COMPARATOR: B - recombinant zoster vaccine

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)
Biological: HZ/su vaccine
0.5ml, intramuscular
Other Names:
  • Recombinant vaccine
ACTIVE_COMPARATOR: C - Live zoster vaccine

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)
Biological: Zostavax
0.65ml, subcutaneous
Biological: Placebo
0.65ml, subcutaneous
Other Names:
  • normal saline
ACTIVE_COMPARATOR: D - recombinant zoster vaccine

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)
Biological: HZ/su vaccine
0.5ml, intramuscular
Other Names:
  • Recombinant vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number
Time Frame: Measured up to Day 730
Measured up to Day 730

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
Time Frame: Measured up to Day 730
Measured up to Day 730

Other Outcome Measures

Outcome Measure
Time Frame
Evaluation of Unsolicited adverse events
Time Frame: Within 30 days of each vaccination
Within 30 days of each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Myron J Levin, M.D., University of Colorado School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

May 1, 2020

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (ESTIMATE)

April 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-3192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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