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A Study to Test the Safety and Antibody Response of V212 in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00696709
First received: June 11, 2008
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  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: 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 Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy 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:
  • 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 ]
  • To assess varicella zoster virus (VZV) vaccine safety and tolerability [ Time Frame: through 28 days postdose 4 ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
heat-treated VZV vaccine
 Biological: Comparator: V212
0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart
Experimental: 2
alternative inactivation method VZV vaccine A
 Biological: Comparator: V212
0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart
Placebo Comparator: 3
Placebo
 Biological: Comparator: Placebo
Placebo; 4-dose regimen administered ~30 days apart.
Experimental: 4
alternative inactivation method VZV vaccine B
 Biological: Comparator: V212
0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart
Experimental: 5
alternative inactivation method VZV vaccine C
 Biological: Comparator: V212
0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 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

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: NCT00696709     History of Changes
Other Study ID Numbers: 2008_528, V212-004
Study First Received: June 11, 2008
Last Updated: December 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Herpes Zoster (Shingles)

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

ClinicalTrials.gov processed this record on May 16, 2013