Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
Completed · Phase 1 · Has a placebo group
Conditions studied: Shingles, Herpes Zoster
In brief
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.
Key facts
- Study ID
- NCT02114333
- Run by
- University of Colorado, Denver
- People needed
- 160
- Starts
- 2014-05-01
- Expected to finish
- 2020-05-01
- Last updated by the study team
- 2020-07-08
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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