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A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(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: NCT00696709
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Herpes Zoster Shingles Biological: Comparator: V212 Biological: Comparator: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Varicella zoster virus (VZV) vaccine will elicit an acceptable VZV-specific immune response as measured by gpELISA [ Time Frame: 28 days postdose 4 ]
  2. To assess varicella zoster virus (VZV) vaccine safety and tolerability [ Time Frame: through 28 days postdose 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00696709


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00696709     History of Changes
Other Study ID Numbers: V212-004
2008_528
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Herpes Zoster (Shingles)

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