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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02114333

Collaborator

GlaxoSmithKline (Industry)

160

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shingles Herpes Zoster	Biological: Zostavax Biological: HZ/su vaccine Biological: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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 Start Date :

May 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number [Measured up to Day 730]

Secondary Outcome Measures

Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) [Measured up to Day 730]

Other Outcome Measures

Evaluation of Unsolicited adverse events [Within 30 days of each vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.