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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

Conditions
-----------------
Herpes Zoster

Intervention / Treatment
-----------------
* Biological: Comparator: V212
* Biological: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine<br>Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine A; 4-dose regimen administered  30 days apart. | Biological: Comparator: V212<br>* 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<br>|
| Experimental: Part 1: Gamma- Irradiated VZV Vaccine A<br>Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered  30 days apart. | Biological: Comparator: V212<br>* 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<br>|
| Placebo Comparator: Part 1: Placebo<br>Participants received a 4-dose placebo regimen administered  30 days apart. | Biological: Comparator: Placebo<br>* Placebo; 4-dose regimen administered  30 days apart.<br>|
| Experimental: Part 2: Gamma- Irradiated VZV Vaccine B<br>Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered  30 days apart. | Biological: Comparator: V212<br>* 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<br>|
| Experimental: Part 2: Gamma- Irradiated VZV Vaccine C<br>Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered  30 days apart. | Biological: Comparator: V212<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients | Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome. | Baseline and  28 days Postdose 4 ( Day 118) | 
| Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients | Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and  28 days Postdose 4 ( Day 118) | 
| Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients | Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and  28 days Postdose 4 ( Day 118) | 
| Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed. | Up to  28 days Postdose 4 (Up to  118 days) | 
| Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card | An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence > 0% in one or more vaccination groups. | Up to Day 5 post any vaccination (Up to  5 days) | 
| Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card | 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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence > 0% in one or more vaccination groups. | Up to  28 days Postdose 4 (Up to  118 days) | 
| Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card | Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed. | Up to  28 days Postdose 4 (Up to  118 days) | 
| Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event | An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed. | Up to Dose 4 (Up to  90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA | Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1. | Baseline and  28 days Postdose 4 ( Day 118) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herpes Zoster (Shingles)