Trial record 2 of 231 for:    "Herpes Zoster" [DISEASE]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02114333
First received: April 11, 2014
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 (HZ/su) contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's 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.


Condition Intervention Phase
Adult
Shingles
Herpes Zoster
Biological: Zostavax
Biological: HZ/su vaccine
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the GSK Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number [ Time Frame: Measured up to Day 730 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) [ Time Frame: Measured up to Day 730 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Unsolicited adverse events [ Time Frame: Within 30 days of each vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: May 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Recombinant vaccine

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114333

Contacts
Contact: Nancy Lang, BSN 303-724-2454 nancy.lang@ucdenver.edu

Locations
United States, Colorado
Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Nancy Lang, BSN    303-724-2454    nancy.lang@ucdenver.edu   
Principal Investigator: Myron J Levin, M.D.         
Sponsors and Collaborators
University of Colorado, Denver
GlaxoSmithKline
Investigators
Principal Investigator: Myron J Levin, M.D. University of Colorado School of Medicine
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02114333     History of Changes
Other Study ID Numbers: 13-3192
Study First Received: April 11, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Shingles vaccine
Immune response
Zoster vaccine

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014