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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Herpes Zoster

Treatments: Biological: Comparator: Placebo; Biological: Comparator: V212

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696709

V212-004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 50 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 5 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Biological: Comparator: V212

Part 1: Gamma- Irradiated VZV Vaccine A

Experimental group

Description:

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

Treatment:

Biological: Comparator: V212

Part 1: Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Comparator: Placebo

Part 2: Gamma- Irradiated VZV Vaccine B

Experimental group

Description:

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

Treatment:

Biological: Comparator: V212

Part 2: Gamma- Irradiated VZV Vaccine C

Experimental group

Description:

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

Treatment:

Biological: Comparator: V212