Herpes Zoster
Conditions
Brief summary
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
Interventions
BIOLOGICALzoster vaccine live (ZOSTAVAX™)
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
BIOLOGICALComparator: Placebo
1 dose 0.65 mL/dose subcutaneous injection of placebo.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
Exclusion criteria
* History of allergy to any vaccine component * Prior receipt of a varicella or zoster vaccine * Ability to defend against infection is suppressed by a medical condition or medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | To Day 28 postvaccination | SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 4 weeks postvaccination | The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | From prevaccination (baseline) to 4 weeks postvaccination | GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination |
Participant flow
Recruitment details
Patients were recruited at 9 sites in the United States. First patient enrolled: May-2006; Last patient last visit: July - 2007
Participants by arm
| Arm | Count |
|---|---|
| ZOSTAVAX™ / Placebo 0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2) | 51 |
| Placebo / ZOSTAVAX™ 0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2) | 50 |
| Total | 101 |
Baseline characteristics
| Characteristic | ZOSTAVAX™ / Placebo | Placebo / ZOSTAVAX™ | Total |
|---|---|---|---|
| Age, Customized 50 to 59 Years of age | 10 participants | 10 participants | 20 participants |
| Age, Customized ≥ 60 Years of age | 41 participants | 40 participants | 81 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Black | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic American | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 47 participants | 42 participants | 89 participants |
| Sex: Female, Male Female | 36 Participants | 24 Participants | 60 Participants |
| Sex: Female, Male Male | 15 Participants | 26 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 98 | 4 / 96 |
| serious Total, serious adverse events | 0 / 98 | 0 / 96 |
Outcome results
Primary
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Time frame: To Day 28 postvaccination
Population: All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZOSTAVAX™ | Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | With Vaccine-related SAEs | 0 Participants |
| ZOSTAVAX™ | Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | Without Vaccine-related SAEs | 100 Participants |
| Placebo | Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | With Vaccine-related SAEs | 0 Participants |
| Placebo | Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | Without Vaccine-related SAEs | 101 Participants |
Secondary
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Time frame: From prevaccination (baseline) to 4 weeks postvaccination
Population: Per-protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZOSTAVAX™ | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | 2.1 Geometric mean fold rise |
| Placebo | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | 1.0 Geometric mean fold rise |
Secondary
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Time frame: 4 weeks postvaccination
Population: Per-protocol population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ZOSTAVAX™ | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 810.1 gpELISA units/mL |
| Placebo | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 391.1 gpELISA units/mL |