Clinical trial NCT01385566: A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
Official title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 223
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
timeFrame: Baseline and 6 weeks following vaccine administration
measure: Number of Participants Reporting an Adverse Experience (AE)
timeFrame: Up to 42 days following vaccine administration
measure: Number of Participants Reporting a Serious Adverse Experience (SAE)
timeFrame: Up to 42 days following vaccine administration
measure: Number of Participants Reporting a Serious Adverse Experience
timeFrame: Within 5 days after the blood draw at approximately 20 months following vaccine administration
measure: Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
timeFrame: Up to 5 days following vaccine administration
measure: Number of Participants Reporting Systemic Adverse Experiences
timeFrame: Up to 42 days following vaccine administration
measure: Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
timeFrame: Up to 42 days following vaccine administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Beals CR, Railkar RA, Schaeffer AK, Levin Y, Kochba E, Meyer BK, Evans RK, Sheldon EA, Lasseter K, Lang N, Weinberg A, Canniff J, Levin MJ. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis. 2016 Aug;16(8):915-22. doi: 10.1016/S1473-3099(16)00133-X. Epub 2016 Apr 6.