Clinical trial NCT04169009: Persistence of Protection by Shingrix
Official title: Persistence of Protection Conferred by Shingrix Against Herpes Zoster
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Keywords: immunology
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-11-19
Enrollment: 105
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

Detailed description: The primary endpoint of this study was the area under the concentration/time curve of quantitative VZV DNA in plasma. However, all the VZV DNA measurements were below the lower limit of quantitation of the assay. Due to this unexpected outcome, we performed a qualitative analysis of presence or absence of VZV DNA in plasma at Day ≥3 after the vOka challenge.

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.

Primary outcomes:
measure: Magnitude of Varicella-Zoster Virus (VZV) DNAemia
timeFrame: Until VZV DNA is undetectable in the blood, measured up to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Clinical Trials Center at University of Colorado Anschutz Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Adriana Weinberg, MD
role: PRINCIPAL_INVESTIGATOR
References: