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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Shingles, Herpes Zoster

Intervention / Treatment
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* Biological: Zostavax
* Biological: HZ/su vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A - Live zoster vaccine<br>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<br>* 0.65ml, subcutaneous<br>Biological: Placebo<br>* 0.65ml, subcutaneous<br>* Other names: normal saline;|
| Active Comparator: B - recombinant zoster vaccine<br>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<br>* 0.5ml, intramuscular<br>* Other names: Recombinant vaccine;|
| Active Comparator: C - Live zoster vaccine<br>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<br>* 0.65ml, subcutaneous<br>Biological: Placebo<br>* 0.65ml, subcutaneous<br>* Other names: normal saline;|
| Active Comparator: D - recombinant zoster vaccine<br>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<br>* 0.5ml, intramuscular<br>* Other names: Recombinant vaccine;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shingles vaccine, Immune response, Zoster vaccine