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A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003)

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ClinicalTrials.gov Identifier: NCT00886613
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : April 13, 2011
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

April 22, 2009
April 23, 2009
March 22, 2011
April 13, 2011
October 6, 2015
March 2009
December 2009   (Final data collection date for primary outcome measure)
  • Number of Participants With a Negative VZV Skin Test at Baseline (Part A) [ Time Frame: 48 hours following administration of the baseline skin test ]
    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.
  • Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B) [ Time Frame: 48-72 hours after administration of skin test at 14-17 days postdose 2 ]
    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.
determine whether VZV Skin Test is a responsive measure of immunogenicity after vaccination with V212 [ Time Frame: 10 Weeks ]
Complete list of historical versions of study NCT00886613 on ClinicalTrials.gov Archive Site
  • VZV Skin Test Reactions at 48 and 72 Hours (Part A) [ Time Frame: 48 hours and 72 hours post administration of baseline skin test ]
    Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test.
  • Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B) [ Time Frame: 1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2 ]
    The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included.
  • Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B) [ Time Frame: 1-5 days post administration of each VZV skin test ]
    The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen.
assess the safety of VZV Skin test antigen and V212 in healthy elderly men and women [ Time Frame: 10 Weeks ]
Number of Participants With a Negative Reaction for Saline at Baseline (Part A) [ Time Frame: 48 hours following administration of the baseline skin test ]
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. The skin reaction (erythema and induration) to saline 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 had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline.
Not Provided
 
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

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.

All eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (VZV Skin Test reagent), 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. Reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Herpes Zoster
  • Biological: V212
    Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31
  • Biological: Comparator: Zostavax™
    Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31
    Other Name: V211 (Zoster Vaccine Live (Oka/Merck))
  • Biological: Comparator: Placebo
    Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31
  • Other: VZV Skin Test
    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.
  • Other: Saline
    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.
  • Experimental: V212
    Participants randomized to receive V212 (heat treated VZV Vaccine)
    Interventions:
    • Biological: V212
    • Other: VZV Skin Test
    • Other: Saline
  • Active Comparator: Zostavax™
    Participants randomized to receive Zostavax™ (Zoster Vaccine, live)
    Interventions:
    • Biological: Comparator: Zostavax™
    • Other: VZV Skin Test
    • Other: Saline
  • Placebo Comparator: Placebo
    Participants randomized to receive placebo
    Interventions:
    • Biological: Comparator: Placebo
    • Other: VZV Skin Test
    • Other: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant has prior history of Varicella
  • Female participants are of non-childbearing potential

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00886613
V212-003
2009_579
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP