Persistence of Protection by Shingrix
Herpes Zoster
About this trial
This is an interventional basic science trial for Herpes Zoster focused on measuring immunology
Eligibility Criteria
Inclusion Criteria:
- Age 50-85
- General good health
- Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
- ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
- ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
- ARM 3 ONLY: Have never received any shingles vaccination
Exclusion Criteria:
- Prior history of herpes zoster (HZ)
- Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.
- Significant immune suppressive illness or therapy
- Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.
- Women of childbearing potential.
- Pregnancy or breastfeeding.
- Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.
Sites / Locations
- Clinical Trials Center at University of Colorado Anschutz Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
ZVL >5 years previously
ZVL 6-12 months previously
No previous ZVL
SRX >5 years previously
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.