Herpes Zoster, Shingles
Conditions
Brief summary
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.
Interventions
BIOLOGICALZoster Vaccine Live
Zoster vaccine live
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* No fever on day of vaccination * Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal * Underlying chronic illness must be stable
Exclusion criteria
* History of hypersensitivity reaction to any vaccine component * Prior history of herpes zoster * Prior receipt of varicella or zoster vaccine * Pregnant or breastfeeding * Have recently received immunoglobulins or blood products other than autologous blood transfusion * Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study * Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study * Use of immunosuppressive therapy * Known or suspected immune dysfunction * Use of nontopical antiviral therapy with activity against herpes virus * Known or suspected active untreated tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody | Day 1 (Baseline) and Week 4 postvaccination | Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline). |
| Geometric Mean Titer (GMT) of VZV Antibody | Day 1 (Baseline) and 4 weeks postvaccination | Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV |
| Percentage of Participants With Clinical Adverse Experiences | Up to 42 days postvaccination | An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. |
| Percentage of Participants Discontinued Due to Clinical Adverse Experiences | Up to 42 days postvaccination | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoster Vaccine Live Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 | 180 |
| Total | 180 |
Baseline characteristics
| Characteristic | Zoster Vaccine Live |
|---|---|
| Age, Customized 60 years or older | 91 Participants |
| Age, Customized Between 50 and 59 years | 89 Participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 96 / 180 |
| serious Total, serious adverse events | 3 / 180 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).
Time frame: Day 1 (Baseline) and Week 4 postvaccination
Population: The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Zoster Vaccine Live | Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody | 2.8 Ratio |
Primary
Geometric Mean Titer (GMT) of VZV Antibody
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
Time frame: Day 1 (Baseline) and 4 weeks postvaccination
Population: The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Zoster Vaccine Live | Geometric Mean Titer (GMT) of VZV Antibody | Day 1 (Baseline) | 66.9 gpELISA units/mL |
| Zoster Vaccine Live | Geometric Mean Titer (GMT) of VZV Antibody | Week 4 postvaccination | 185.4 gpELISA units/mL |
Primary
Percentage of Participants Discontinued Due to Clinical Adverse Experiences
Time frame: Up to 42 days postvaccination
Population: Safety population which included all vaccinated participants who had any safety follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zoster Vaccine Live | Percentage of Participants Discontinued Due to Clinical Adverse Experiences | 0 Percentage of Participants |
Primary
Percentage of Participants With Clinical Adverse Experiences
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Time frame: Up to 42 days postvaccination
Population: Safety population which included all vaccinated participants who had any safety follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoster Vaccine Live | Percentage of Participants With Clinical Adverse Experiences | Injection site adverse experiences | 53.3 Percentage of Participants |
| Zoster Vaccine Live | Percentage of Participants With Clinical Adverse Experiences | Non-injection site adverse experiences | 24.4 Percentage of Participants |