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A Study of an Investigational V212/Heat-Treated VZV Vaccine in Immunocompromised Adults

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00535236
First received: September 25, 2007
Last updated: January 28, 2010
Last verified: January 2010
History of Changes
  Purpose

The proposed indication for the investigational heat-treated varicella-zoster virus (VZV) vaccine is the prevention of herpes zoster (HZ) and HZ-related complications in immunocompromised individuals.


Condition Intervention Phase
Herpes Zoster
Herpes Zoster-related Complications
 Biological: Comparator: V212
Biological: Comparator: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Immunogenicity of V212 when administered to immunocompromised patients [ Time Frame: 28 days postdose 4 ] [ Designated as safety issue: No ]
  • Safety and tolerability of V212 when administered to immunocompromised patients [ Time Frame: through 28 days postdose 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability of V212 in immunocompromised patients [ Time Frame: 28 days post dose 4 ] [ Designated as safety issue: Yes ]

Enrollment: 341
Study Start Date: November 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: Vaccine
 Biological: Comparator: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
Placebo Comparator: 2
Arm 2: Pbo Comparator
 Biological: Comparator: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
  • HIV-infected patients with a baseline CD4 cell count < or = to 200 cells/mm^3
  • Patients with hematologic malignancies; or patients who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies

Exclusion Criteria:

  • History of allergy to any vaccine component
  • Prior history of HZ
  • Prior history of receipt of any varicella or zoster vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535236

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00535236     History of Changes
Other Study ID Numbers: 2007_608, V212-002
Study First Received: September 25, 2007
Last Updated: January 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Prevention of herpes zoster and HZ-related complications

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

ClinicalTrials.gov processed this record on May 16, 2013