NCT02114333

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Shingles
• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Zostavax	0.65ml, subcutaneous
BIOLOGICAL	HZ/su vaccine	0.5ml, intramuscular
BIOLOGICAL	Placebo	0.65ml, subcutaneous

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-03-01
• Completion: 2020-05-01
• First posted: 2014-04-15
• Last updated: 2020-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study