A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
1 other identifier
interventional
223
0 countries
N/A
Brief Summary
This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedResults Posted
Study results publicly available
February 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 23, 2016
May 1, 2016
1.7 years
June 28, 2011
December 11, 2012
May 19, 2016
Conditions
Outcome Measures
Primary Outcomes (7)
Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
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.
Baseline and 6 weeks following vaccine administration
Number of Participants Reporting an Adverse Experience (AE)
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.
Up to 42 days following vaccine administration
Number of Participants Reporting a Serious Adverse Experience (SAE)
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.
Up to 42 days following vaccine administration
Number of Participants Reporting a Serious Adverse Experience
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
Within 5 days after the blood draw at approximately 20 months following vaccine administration
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
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.
Up to 5 days following vaccine administration
Number of Participants Reporting Systemic Adverse Experiences
Systemic AEs included all reported AEs except injection-site AEs
Up to 42 days following vaccine administration
Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
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.
Up to 42 days following vaccine administration
Study Arms (6)
Full Dose Subcutaneous
ACTIVE COMPARATORParticipants 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.
1/3 Dose Subcutaneous
EXPERIMENTALParticipants 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.
Full Dose Intradermal
EXPERIMENTALParticipants 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.
1/3 Dose Intradermal
EXPERIMENTALParticipants 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.
1/10 Dose Intradermal
EXPERIMENTALParticipants 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.
1/27 Dose Intradermal
EXPERIMENTALParticipants 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.
Interventions
One 0.65 mL injection subcutaneously on Day 1
One approximately 0.22 mL injection subcutaneously on Day 1
Two intradermal injections of approximately 0.15 mL each on Day 1
One intradermal injection of approximately 0.1 mL on Day 1
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
One intradermal placebo injection of approximately 0.1 mL on Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27061887RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
June 30, 2011
Study Start
September 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 23, 2016
Results First Posted
February 21, 2013
Record last verified: 2016-05