Clinical trial NCT00696709: A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Zoster
Keywords: Herpes Zoster (Shingles)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 290
Sex: ALL
Minimum age (years): 50
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline and ~28 days Postdose 4 (~Day 118)
measure: Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients
timeFrame: Baseline and ~28 days Postdose 4 (~Day 118)
measure: Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients
timeFrame: Baseline and ~28 days Postdose 4 (~Day 118)
measure: Percentage of Participants With a Serious Adverse Event
timeFrame: Up to ~28 days Postdose 4 (Up to ~118 days)
measure: Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card
timeFrame: Up to Day 5 post any vaccination (Up to ~5 days)
measure: Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card
timeFrame: Up to ~28 days Postdose 4 (Up to ~118 days)
measure: Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card
timeFrame: Up to ~28 days Postdose 4 (Up to ~118 days)
measure: Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event
timeFrame: Up to Dose 4 (Up to ~90 days)
Secondary outcomes:
measure: Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA
timeFrame: Baseline and ~28 days Postdose 4 (~Day 118)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: