Herpes Zoster Clinical Trial
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
NCT number | NCT02114333 |
Other study ID # | 13-3192 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | May 2020 |
Verified date | July 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | May 2020 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluation of Unsolicited adverse events | Within 30 days of each vaccination | ||
Primary | Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number | Measured up to Day 730 | ||
Secondary | Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) | Measured up to Day 730 |
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