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Persistence of Protection by Shingrix | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT04169009

Persistence of Protection by Shingrix

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 (F...

Lead sponsor: University of Colorado, Denver•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Colorado, Denver

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

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.

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 15, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment105

Start dateJul 2020

Last updatedOct 15, 2024

Condition

Locations shown

Clinical Trials Center at University of Colorado Anschutz Medical Center

Aurora, Colorado

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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