ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of an Investigational V212/Heat-Treated VZV Vaccine in Immunocompromised Adults (V212-002)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00535236
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Herpes Zoster Herpes Zoster-related Complications Biological: Comparator: V212 Biological: Comparator: Placebo Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immunogenicity of V212 when administered to immunocompromised patients [ Time Frame: 28 days postdose 4 ]
  2. Safety and tolerability of V212 when administered to immunocompromised patients [ Time Frame: through 28 days postdose 4 ]

Secondary Outcome Measures :
  1. Safety and tolerability of V212 in immunocompromised patients [ Time Frame: 28 days post dose 4 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535236


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535236     History of Changes
Other Study ID Numbers: V212-002
2007_608
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of herpes zoster and HZ-related complications

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Vaccines
Immunologic Factors
Physiological Effects of Drugs