Overview

This trial is active, not recruiting.

Conditions shingles, herpes zoster
Treatments zostavax, hz/su vaccine, placebo
Phase phase 1
Sponsor University of Colorado, Denver
Collaborator GlaxoSmithKline
Start date May 2014
End date March 2016
Trial size 160 participants
Trial identifier NCT02114333, 13-3192

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Active Comparator)
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)
zostavax
0.65ml, subcutaneous
placebo normal saline
0.65ml, subcutaneous
(Active Comparator)
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)
hz/su vaccine Recombinant vaccine
0.5ml, intramuscular
(Active Comparator)
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)
zostavax
0.65ml, subcutaneous
placebo normal saline
0.65ml, subcutaneous
(Active Comparator)
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)
hz/su vaccine Recombinant vaccine
0.5ml, intramuscular

Primary Outcomes

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

Secondary Outcomes

Measure
Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
time frame: Measured up to Day 730

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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.

Additional Information

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
Principal investigator Myron J Levin, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.