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

NCT ID: NCT00886613

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-12-31

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.

Detailed Description

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V212

Participants randomized to receive V212 (heat treated VZV Vaccine)

Group Type: EXPERIMENTAL

V212

Intervention Type: BIOLOGICAL

Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31

VZV Skin Test

Intervention Type: OTHER

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.

Saline

Intervention Type: OTHER

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.

Zostavax™

Participants randomized to receive Zostavax™ (Zoster Vaccine, live)

Group Type: ACTIVE_COMPARATOR

Comparator: Zostavax™

Intervention Type: BIOLOGICAL

Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31

VZV Skin Test

Intervention Type: OTHER

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.

Saline

Intervention Type: OTHER

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.

Placebo

Participants randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: BIOLOGICAL

Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31

VZV Skin Test

Intervention Type: OTHER

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.

Saline

Intervention Type: OTHER

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.

Interventions

V212

Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31

Intervention Type: BIOLOGICAL

Comparator: Zostavax™

Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31

Intervention Type: BIOLOGICAL

Comparator: Placebo

Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31

Intervention Type: BIOLOGICAL

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

V211 (Zoster Vaccine Live (Oka/Merck))

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 37781954 (View on PubMed)

Other Identifiers

2009_579

Identifier Type: -

Identifier Source: secondary_id

V212-003

Identifier Type: -

Identifier Source: org_study_id