Persistence of Protection by Shingrix

Herpes Zoster Clinical Trial

Official title:

Persistence of Protection Conferred by Shingrix Against Herpes Zoster

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169009
• Other study ID #: 18-0580
• Secondary ID: 1U01AI141919-01
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Zostavax
Intradermal injection of Zostavax
• Shingrix
Given to subjects in Arm 4 who've never had a herpes zoster vaccine

Locations

Country	Name	City	State
United States	Clinical Trials Center at University of Colorado Anschutz Medical Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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