Persistence of Protection by Shingrix

Phase 4

Completed

• Conditions: Herpes Zoster
• Interventions: Biological: Zostavax; Biological: Shingrix

• Registration Number: NCT04169009
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2020-07-28
• Primary Completion: 2023-03-31
• Study Completion: 2024-06-13
• Status Verified: 2024-07
• Results First Submitted: 2024-07-02
• Results First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Results First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRX >5 years previously	Zostavax	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.
ZVL 6-12 months previously	Zostavax	Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
ZVL >5 years previously	Zostavax	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.
No previous ZVL	Zostavax	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.
No previous ZVL	Shingrix	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.

Primary Outcome Measures

Name	Time	Method
Magnitude of Varicella-Zoster Virus (VZV) DNAemia	Until VZV DNA is undetectable in the blood, measured up to Day 7	Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.

Trial Locations

Locations (1)

Clinical Trials Center at University of Colorado Anschutz Medical Center; 🇺🇸 Aurora, Colorado, United States