Text Size

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: April 10, 2013
Last verified: March 2013
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 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.


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 postvaccination ] [ Designated as safety issue: No ]
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)

  • Geometric Mean Fold Rise (GMFR) From Day 1 to Week 6 Postvaccination in VZV Antibody Titers [ Time Frame: Day 1 and Week 6 postvaccination ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Reporting One or More Adverse Experiences [ Time Frame: Up to 42 days postvaccination ] [ Designated as safety issue: Yes ]

    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.



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 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 (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™

Detailed Description:

After completion of the 42-day postvaccination period, participants will remain in study follow-up for 1-year postvaccination

  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 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
  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
Results First Received: April 10, 2013
Last Updated: April 10, 2013
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 June 17, 2013