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A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

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ClinicalTrials.gov Identifier: NCT01385566
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : February 21, 2013
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal Biological: Full Dose Intradermal Placebo Biological: Intradermal Placebo Phase 1

Detailed Description:
This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
Study Start Date : September 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Full Dose Subcutaneous
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
 Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
One 0.65 mL injection subcutaneously on Day 1
Other Name: V211
Biological: Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Experimental: 1/3 Dose Subcutaneous
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
 Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
One approximately 0.22 mL injection subcutaneously on Day 1
Other Name: V211
Biological: Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Experimental: Full Dose Intradermal
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
 Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
Two intradermal injections of approximately 0.15 mL each on Day 1
Other Name: V211
Biological: Full Dose Intradermal Placebo
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
Experimental: 1/3 Dose Intradermal
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
 Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Other Name: V211
Biological: Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Experimental: 1/10 Dose Intradermal
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
 Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Other Name: V211
Biological: Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Experimental: 1/27 Dose Intradermal
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
 Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Other Name: V211
Biological: Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies [ Time Frame: Baseline and 6 weeks following vaccine administration ]
    VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.

  2. Number of Participants Reporting an Adverse Experience (AE) [ Time Frame: Up to 42 days following vaccine administration ]

    An AE is defined as any unfavorable and unintended change in the

    structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.


  3. Number of Participants Reporting a Serious Adverse Experience (SAE) [ Time Frame: Up to 42 days following vaccine administration ]
    An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.

  4. Number of Participants Reporting a Serious Adverse Experience [ Time Frame: Within 5 days after the blood draw at approximately 20 months following vaccine administration ]
    An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention

  5. Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) [ Time Frame: Up to 5 days following vaccine administration ]
    The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.

  6. Number of Participants Reporting Systemic Adverse Experiences [ Time Frame: Up to 42 days following vaccine administration ]
    Systemic AEs included all reported AEs except injection-site AEs

  7. Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) [ Time Frame: Up to 42 days following vaccine administration ]
    Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
  • Temperature less than 100.4 °F on day of vaccination
  • Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
  • In good health

Exclusion Criteria:

  • History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
  • Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
  • Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
  • Prior history of herpes zoster
  • Prior receipt of any varicella or zoster vaccine
  • Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination
  • On immunosuppressive therapy
  • Known or suspected immune dysfunction
  • Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
  • Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
  • Not ambulatory
  • Pregnant or breastfeeding
  • Use of nontopical antiviral therapy with activity against herpes viruses
  • Active untreated tuberculosis
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01385566     History of Changes
Other Study ID Numbers: V211-051
First Posted: June 30, 2011    Key Record Dates
Results First Posted: February 21, 2013
Last Update Posted: June 23, 2016
Last Verified: May 2016

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