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 5, 2015

Last verified: October 2015

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: Shingles

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

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 (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535236

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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

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.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00535236 History of Changes
Other Study ID Numbers:	V212-002 2007_608
Study First Received:	September 25, 2007
Last Updated:	October 5, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016

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