A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003)
A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate Biomarkers of Immunity to Varicella Zoster Virus Following Immunization With V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine or With ZOSTAVAX in Healthy Volunteers
2 other identifiers
interventional
120
0 countries
N/A
Brief Summary
A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™. The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. The first 42 eligible participants were enrolled into Part A of the study. In Part A, the reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in Part A were performed at 48 hours post administration. After all skin test reactions were obtained at baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction. The interim analysis from Part A confirmed the study sample size, an additional 78 subjects were enrolled into Part B to achieve the planned sample size (N=120). The study procedures for Part B of the study were identical to those in Part A with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2009
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
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
April 13, 2011
CompletedOctober 6, 2015
October 1, 2015
9 months
April 22, 2009
March 22, 2011
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With a Negative VZV Skin Test at Baseline (Part A)
Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure \< 5mm for saline and \< 5mm for the VZV antigen were considered to have a negative baseline skin test.
48 hours following administration of the baseline skin test
Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)
Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination. For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring \>= 5mm for the VZV antigen was considered a positive skin test.
48-72 hours after administration of skin test at 14-17 days postdose 2
Secondary Outcomes (3)
VZV Skin Test Reactions at 48 and 72 Hours (Part A)
48 hours and 72 hours post administration of baseline skin test
Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)
1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2
Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)
1-5 days post administration of each VZV skin test
Other Outcomes (1)
Number of Participants With a Negative Reaction for Saline at Baseline (Part A)
48 hours following administration of the baseline skin test
Study Arms (3)
V212
EXPERIMENTALParticipants randomized to receive V212 (heat treated VZV Vaccine)
Zostavax™
ACTIVE COMPARATORParticipants randomized to receive Zostavax™ (Zoster Vaccine, live)
Placebo
PLACEBO COMPARATORParticipants randomized to receive placebo
Interventions
Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31
Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31
Three intradermal injections of the 0.1 ml varicella antigen (VZV Skin Test reagent) were administered, once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination.
One intradermal injection of the 0.1 ml saline was administered at the time of the baseline VZV skin test prior to the first vaccination. Saline and VZV skin test reagents were administered on opposite arms.
Eligibility Criteria
You may qualify if:
- Participant has prior history of Varicella
- Female participants are of non-childbearing potential
You may not qualify if:
- Participant has had a hypersensitivity reaction to any vaccine component
- Participant has a prior history of Herpes Zoster
- Participant has received any Varicella or Zoster vaccine including Zostavax
- Participant has a history of immunosuppression caused by disease, corticosteroids, cancer therapy or organ transplant
- Participant has an active cancer
- Participant has received or will receive a live virus vaccine or an inactivated virus vaccine 4 weeks prior to participating in study (with the exception of influenza vaccine)
- Participant is not bed-ridden or homebound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
PMID: 37781954DERIVED
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.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 6, 2015
Results First Posted
April 13, 2011
Record last verified: 2015-10