Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

Phase 3

Completed

• Conditions: Herpes Zoster; Varicella-zoster Vaccine
• Interventions: Biological: Zoster Vaccine, Live

• Registration Number: NCT01245751
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Timeline

• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Study Start: 2011-04
• Primary Completion: 2012-07
• Results First Submitted: 2013-04-10
• Results First Submitted QC: 2013-04-10
• Results First Posted: 2013-05-29
• Study Completion: 2015-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: First Dose Participants ≥70 years of age	Zoster Vaccine, Live	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
Group 1: Booster Dose Participants ≥70 years of age	Zoster Vaccine, Live	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)
Group 3: First Dose Participants ≥60 and <70 years of age	Zoster Vaccine, Live	Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live
Group 4: First Dose Participants ≥50 and <60 years of age	Zoster Vaccine, Live	Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)	Day 1 (Baseline) and Week 6 postvaccination	VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Adverse Experiences	Up to 42 days postvaccination	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.