- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696709
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
October 18, 2019 updated by: Merck Sharp & Dohme LLC
A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
290
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
|
Experimental: 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.
|
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
|
Placebo Comparator: Part 1: Placebo
Participants received a 4-dose placebo regimen administered ~30 days apart.
|
Placebo; 4-dose regimen administered ~30 days apart.
|
Experimental: 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.
|
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
|
Experimental: 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.
|
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
|
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
Time Frame: Baseline and ~28 days Postdose 4 (~Day 118)
|
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
Time Frame: Baseline and ~28 days Postdose 4 (~Day 118)
|
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
Time Frame: Baseline and ~28 days Postdose 4 (~Day 118)
|
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
Time Frame: Up to ~28 days Postdose 4 (Up to ~118 days)
|
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
Time Frame: Up to Day 5 post any vaccination (Up to ~5 days)
|
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
Time Frame: Up to ~28 days Postdose 4 (Up to ~118 days)
|
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
Time Frame: Up to ~28 days Postdose 4 (Up to ~118 days)
|
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
Time Frame: Up to Dose 4 (Up to ~90 days)
|
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
Time Frame: Baseline and ~28 days Postdose 4 (~Day 118)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2008
Primary Completion (Actual)
November 16, 2009
Study Completion (Actual)
November 16, 2009
Study Registration Dates
First Submitted
June 11, 2008
First Submitted That Met QC Criteria
June 12, 2008
First Posted (Estimate)
June 13, 2008
Study Record Updates
Last Update Posted (Actual)
November 8, 2019
Last Update Submitted That Met QC Criteria
October 18, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V212-004 (Other Identifier: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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