A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-12

Study Completion Date

2009-11-16

Brief Summary

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The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.

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Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine

Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine A; 4-dose regimen administered \~30 days apart.

Group Type EXPERIMENTAL

Comparator: V212

Intervention Type BIOLOGICAL

0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart

Part 1: Gamma- Irradiated VZV Vaccine A

Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.

Group Type EXPERIMENTAL

Comparator: V212

Intervention Type BIOLOGICAL

0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart

Part 1: Placebo

Participants received a 4-dose placebo regimen administered \~30 days apart.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

Placebo; 4-dose regimen administered \~30 days apart.

Part 2: Gamma- Irradiated VZV Vaccine B

Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.

Group Type EXPERIMENTAL

Comparator: V212

Intervention Type BIOLOGICAL

0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart

Part 2: Gamma- Irradiated VZV Vaccine C

Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.

Group Type EXPERIMENTAL

Comparator: V212

Intervention Type BIOLOGICAL

0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart

Interventions

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Comparator: V212

0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart

Intervention Type BIOLOGICAL

Comparator: Placebo

Placebo; 4-dose regimen administered \~30 days apart.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Must be 50 to 59 years of age
* No fever on vaccination days
* Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
* Females of child-bearing potential must use acceptable forms of birth control

Exclusion Criteria

* Prior history of shingles
* Prior receipt of any chickenpox or shingles vaccine
* Pregnant or breastfeeding
* Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
* Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
* Received immunoglobulin or blood products
* Receiving treatment that may weaken the immune system
* Have an immune system disorder

Minimum Eligible Age

50 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes