Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 600
- Primary Endpoint
- Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
Study Overview
Brief Summary
This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.
Detailed Description
All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All Groups:
- •Must not have a fever of ≥100.4° F on the day of vaccination
- •Any underlying chronic illness must be in stable condition
- •History of varicella or residence in a VZV-endemic area for ≥30 years
- •70 years of age or older
- •Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
- •70 years of age or older
- •60 to 69 years of age
- •50 to 59 years of age
Exclusion Criteria
- •All Groups:
- •History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
- •Prior history of herpes zoster
- •Pregnant or breast-feeding, or expecting to conceive within the duration of the study
- •Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
- •Received any other vaccine within 4 weeks prevaccination
- •On immunosuppressive therapy
- •Has known or suspected immune dysfunction
- •Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
- •Groups 2, 3, and 4:
- •Has previously received any varicella or zoster vaccine
Arms & Interventions
Group 1: Booster Dose Participants ≥70 years of age
Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)
Intervention: Zoster Vaccine, Live (Biological)
Group 2: First Dose Participants ≥70 years of age
Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age
Intervention: Zoster Vaccine, Live (Biological)
Group 3: First Dose Participants ≥60 and <70 years of age
Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live
Intervention: Zoster Vaccine, Live (Biological)
Group 4: First Dose Participants ≥50 and <60 years of age
Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live
Intervention: Zoster Vaccine, Live (Biological)
Outcomes
Primary Outcomes
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
Time Frame: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
Time Frame: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Secondary Outcomes
- Number of Participants Reporting One or More Adverse Experiences(Up to 42 days postvaccination)