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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00535236
First received: September 25, 2007
Last updated: October 31, 2013
Last verified: October 2013

September 25, 2007
October 31, 2013
November 2007
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00535236 on ClinicalTrials.gov Archive Site
Safety and tolerability of V212 in immunocompromised patients [ Time Frame: 28 days post dose 4 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
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A Study of an Investigational V212/Heat-Treated VZV Vaccine in Immunocompromised Adults (V212-002)(COMPLETED)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Herpes Zoster
  • Herpes Zoster-related Complications
  • Biological: Comparator: V212
    0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
  • Biological: Comparator: Placebo
    0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
  • Experimental: 1
    Arm 1: Vaccine
    Intervention: Biological: Comparator: V212
  • Placebo Comparator: 2
    Arm 2: Pbo Comparator
    Intervention: Biological: Comparator: Placebo
Mullane KM, Winston DJ, Wertheim MS, Betts RF, Poretz DM, Camacho LH, Pergam SA, Mullane MR, Stek JE, Sterling TM, Zhao Y, Manoff SB, Annunziato PW. Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults. J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
341
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00535236
V212-002, 2007_608
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP