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Completed

NCT Number: NCT01245751

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

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Varicella-zoster Vaccine Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine, Live

Biological

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Other names: V211, ZOSTAVAX™

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Number of Participants Reporting One or More Adverse Experiences

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Duke University
  • University of Colorado, Denver

Registry information

Official study title

Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Nov 22, 2010
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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