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Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029 AM1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Colorado, Denver
Duke University
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01245751
First received: November 19, 2010
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

This study is being conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information will be compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who are receiving their first dose of Zoster Vaccine, Live. The study will determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age causes 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 causes an acceptable rise in the level of Varicella zoster virus (VZV) antibodies.


Condition Intervention Phase
Herpes Zoster
 Biological: Zoster Vaccine, Live
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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™

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Geometric mean titer (GMT) of the antibody responses to Varicella Zoster Virus (VZV) [ Time Frame: Week 6 post-vaccination ] [ Designated as safety issue: No ]
  • Geometric mean fold rise (GMFR) in VZV antibody titers [ Time Frame: Baseline to Week 6 post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants reporting one or more adverse experiences [ Time Frame: Through 42 days post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Booster Dose
Herpes Zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study (NCT00007501)
 Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™
Active Comparator: 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
 Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™
Active Comparator: 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
 Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™
Experimental: 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
 Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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) (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 pre-vaccination
    • On immunosuppressive therapy
    • Has known or suspected immune dysfunction
    • Is taking any non-topical antiviral therapy with activity against Herpes viruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.

  • Groups 2, 3, and 4:

    • Has previously received any Varicella or Zoster vaccine
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01245751     History of Changes
Other Study ID Numbers: V211-029
Study First Received: November 19, 2010
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Shingles
vaccine

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013