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Completed

NCT Number: NCT01385566

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

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

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous

Biological

One 0.65 mL injection subcutaneously on Day 1

Other names: V211

ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous

Biological

One approximately 0.22 mL injection subcutaneously on Day 1

Other names: V211

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal

Biological

Two intradermal injections of approximately 0.15 mL each on Day 1

Other names: V211

ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal

Biological

One intradermal injection of approximately 0.1 mL on Day 1

Other names: V211

Full Dose Intradermal Placebo

Biological

Two intradermal placebo injections of approximately 0.15 mL each on Day 1

Intradermal Placebo

Biological

One intradermal placebo injection of approximately 0.1 mL on Day 1

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2011
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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