Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02114333
Other study ID # 13-3192
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2014
Est. completion date May 2020

Study information

Verified date July 2020
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.


Description:

160 people from the Denver area will participate. Duration is up to 5 years with 10-12 visits in that period. Subjects are randomized into one of 4 arms to receive either Zostavax or HZ/su. In this single blind study all subjects receive 2 injections: one at the first visit (Day 0) and the second at Day 60. HZ/su subjects will receive vaccine at both visits; Zostavax subjects will receive vaccine at the first visit and a placebo at the Day 60 visit. Blood is collected from all subjects at most visits. Some subjects spit into a tube for saliva collection. A urine sample is collected prior to vaccination if subject is a woman of childbearing potential. Subjects are asked to complete a diary to record any reactions in the 30 days after each injection. The Day 90 visit is the last one until the annual visits for blood draws begin at Day 365. Some subjects are also seen at Year 2 and Year 4; all subjects are seen at Year 5 for blood draw.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date May 2020
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria:

- History of varicella or residence int he US for 30 years

- For Arms C and D - prior live zoster vaccine at least 5 years previously

- For Arms A and B - Age 50-59 or 70-85

- For Arms C and D - Age 70-85

- For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine

Exclusion Criteria:

- History of herpes zoster

- For Arms A and B - prior live zoster vaccine

- Immune compromising illness or therapies or chronic illness

- Allergy to previous herpes zoster vaccine

- Other investigational drugs or vaccines within the past 6 months before the study and until last visit

- Blood products for 3 months prior to or planned during the study

- Concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination.

- Vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine.

- Pregnancy or breast-feeding

- Current drug addiction or alcoholism.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Zostavax
0.65ml, subcutaneous
HZ/su vaccine
0.5ml, intramuscular
Placebo
0.65ml, subcutaneous

Locations

Country Name City State
United States Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluation of Unsolicited adverse events Within 30 days of each vaccination
Primary Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number Measured up to Day 730
Secondary Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) Measured up to Day 730
See also
  Status Clinical Trial Phase
Completed NCT03120364 - Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over Phase 3
Completed NCT01165203 - Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects Phase 2
Recruiting NCT06088745 - A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine Phase 3
Completed NCT01385566 - A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2) Phase 1
Completed NCT01911065 - T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020 Phase 4
Completed NCT01137669 - ZOSTAVAX® in Renal Transplant Patients Phase 1
Completed NCT00550745 - ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020) Phase 4
Completed NCT01132729 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions N/A
Completed NCT01132716 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions N/A
Completed NCT00231816 - A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) Phase 3
Completed NCT02852876 - Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food Phase 1
Completed NCT05082688 - Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX) Phase 2
Completed NCT04099706 - Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT N/A
Active, not recruiting NCT04091451 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles Phase 3
Completed NCT02519855 - Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) Phase 3
Completed NCT04523246 - Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents Early Phase 1
Completed NCT05047770 - A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine Phase 3
Completed NCT03314103 - Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age Phase 3
Completed NCT01527370 - Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) Phase 3
Completed NCT01954251 - Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older Phase 3