Herpes Zoster, Shingles
Conditions
Brief summary
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
Interventions
BIOLOGICALZoster Vaccine Live
One approximately 0.65 mL injection subcutaneously on Day 1
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 illnesses must be stable
Exclusion criteria
* History of hypersensitivity reaction to any vaccine component * Prior receipt of a varicella or zoster vaccine * Prior history of herpes zoster * Have recently had another vaccination * Have recently received blood products other than autologous blood transfusion * Pregnant or breast feeding * Use of immunosuppressive therapy * Known or suspected immune dysfunction * Use of nontopical antiviral therapy with activity against herpesvirus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination | Prevaccination up to 6 weeks postvaccination | Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA). |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination | Prevaccination up to 6 weeks postvaccination | GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1. |
| Number of Participants With Serious Adverse Events | Up to 42 days postvaccination | A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. |
Participant flow
Recruitment details
Ten sites in India enrolled adult participants in the study.
Participants by arm
| Arm | Count |
|---|---|
| Zoster Vaccine Live A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity. | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Zoster Vaccine Live |
|---|---|
| Age, Continuous | 58.6 Years STANDARD_DEVIATION 7.1 |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 250 |
| serious Total, serious adverse events | 2 / 250 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
Time frame: Prevaccination up to 6 weeks postvaccination
Population: This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Zoster Vaccine Live | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination | 2.8 Ratio |
Primary
Number of Participants With Serious Adverse Events
A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment.
Time frame: Up to 42 days postvaccination
Population: This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zoster Vaccine Live | Number of Participants With Serious Adverse Events | 2 Participants |
Primary
The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Time frame: Prevaccination up to 6 weeks postvaccination
Population: This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Zoster Vaccine Live | The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination | Prevaccination (n=250) | 149.8 gpELISA units/mL |
| Zoster Vaccine Live | The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination | 6 weeks postvaccination (n=243) | 410.8 gpELISA units/mL |