Phase 3
N=600
Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
Herpes Zoster · Varicella-zoster Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01245751 ↗Enrolled (actual)
600
Serious AEs
11.0%
Results posted
May 2013
Primary outcome: Primary: Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) — 248.0; 254.2; 389.1; 368.6 gpELISA Units/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoster Vaccine, Live (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) |
248.0; 254.2; 389.1; 368.6 | <0.001 sig |
| PRIMARY Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers |
1.5 | <0.001 sig |
| SECONDARY Number of Participants Reporting One or More Adverse Experiences |
104; 95; 72; 72; 68; 61 | — |
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.
Eligibility Criteria
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
- Group 1:
- 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
- Group 2:
- 70 years of age or older
- Group 3:
- 60 to 69 years of age
- Group 4:
- 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
Data sourced from ClinicalTrials.gov (NCT01245751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.