A Study to Test the Safety and Antibody Response of V212 in Healthy Adults - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00696709

Purpose

The purpose of the study is to see if an investigational vaccine for shingles is safe and well tolerated and brings about an acceptable antibody response.

Condition	Intervention	Phase
Herpes Zoster Shingles	Biological: V212 Biological: Placebo (unspecified)	Phase I

MedlinePlus related topics: Shingles

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

Further study details as provided by Merck:

Primary Outcome Measures:

Varicella zoster virus (VZV) vaccine will elicit an acceptable VZV-specific immune response as measured by gpELISA. [ Time Frame: 28 days postdose 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental heat-treated VZV vaccine	Biological: V212 heat-treated Varicella zoster virus (VZV) vaccine or gamma-irradiated VZV vaccine; 4-dose regimen administered ~30 days apart
2: Experimental gamma-irradiated VZV vaccine	Biological: V212 heat-treated Varicella zoster virus (VZV) vaccine or gamma-irradiated VZV vaccine; 4-dose regimen administered ~30 days apart
3: Placebo Comparator placebo	Biological: Placebo (unspecified) Placebo; 4-dose regimen administered ~30 days apart.

Eligibility

Ages Eligible for Study:	50 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Must be 50 to 59 years of age
No fever on vaccination days
Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
Females of child-bearing potential must use acceptable forms of birth control

Exclusion Criteria:

Prior history of shingles
Prior receipt of any chickenpox or shingles vaccine
Pregnant or breastfeeding
Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
Received immunoglobulin or blood products
Receiving treatment that may weaken the immune system
Have an immune system disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696709

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Alabama
Call for Information	Recruiting
Ozark, Alabama, United States, 36360
Call for Information	Recruiting
Columbiana, Alabama, United States, 35051
United States, Florida
Call for Information	Recruiting
Pembroke Pines, Florida, United States, 33024-0000
United States, Kansas
Call for Information	Recruiting
Overland Park, Kansas, United States, 66211
United States, Kentucky
Call for Information	Recruiting
Lexington, Kentucky, United States, 40509
Call for Information	Recruiting
Bardstown, Kentucky, United States, 40004-1142
United States, Missouri
Call for Information	Recruiting
Kansas City, Missouri, United States, 64114-0000

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_528, V212-004
Study First Received:	June 11, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00696709
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Antibodies
DNA Virus Infections

Healthy
Immunoglobulins
Herpesviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009