Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
Shingles, Herpes Zoster
About this trial
This is an interventional basic science trial for Shingles focused on measuring Shingles vaccine, Immune response, Zoster vaccine
Eligibility Criteria
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.
Sites / Locations
- Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
A - Live zoster vaccine
B - recombinant zoster vaccine
C - Live zoster vaccine
D - recombinant 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)
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)
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)
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)