Persistence of Protection by Shingrix

NCT04169009 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 18-05801U01AI141919-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

immunology

Outcome Measures

Primary Outcomes (1)

• Magnitude of Varicella-Zoster Virus (VZV) DNAemia

  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.

  Until VZV DNA is undetectable in the blood, measured up to Day 7

Study Arms (4)

ZVL >5 years previously

ACTIVE COMPARATOR

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.

Biological: Zostavax

ZVL 6-12 months previously

ACTIVE COMPARATOR

Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.

Biological: Zostavax

No previous ZVL

ACTIVE COMPARATOR

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.

Biological: Zostavax; Biological: Shingrix

SRX >5 years previously

ACTIVE COMPARATOR

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.

Biological: Zostavax

Interventions

Zostavax BIOLOGICAL

Intradermal injection of Zostavax

No previous ZVL; SRX >5 years previously; ZVL 6-12 months previously; ZVL >5 years previously

Shingrix BIOLOGICAL

Given to subjects in Arm 4 who've never had a herpes zoster vaccine

No previous ZVL

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior history of herpes zoster (HZ)
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Clinical Trials Center at University of Colorado Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Adriana Weinberg MD
• Organization: University of Colorado Anschutz Medical Campus

adriana.weinberg@cuanschutz.edu

303-724-4480

Study Officials

• Adriana Weinberg, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: November 19, 2019
• Study Start: July 28, 2020
• Primary Completion: March 31, 2023
• Study Completion: June 13, 2024
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)