Herpes Zoster
Conditions
Brief summary
The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
Detailed description
The duration of treatment is 4 weeks.
Interventions
BIOLOGICALComparator: zoster vaccine live (Oka/Merck) refrigerated formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
BIOLOGICALComparator: zoster vaccine live (Oka/Merck) frozen formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)
Exclusion criteria
* Prior history of herpes zoster (shingles) * Prior receipt of varicella or zoster vaccine * Immunosuppressed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 4 weeks | The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | 4 weeks | Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 from prevaccination to Week 4 postvaccination |
Participant flow
Recruitment details
Patients were recruited at 14 sites in the United States. First patient randomized: 08Aug2005; Last patient last visit: 28Nov2005
Participants by arm
| Arm | Count |
|---|---|
| ZOSTAVAX™ With PGSU ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\
45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection | 182 |
| ZOSTAVAX™ With PGS ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\
57,000 PFU), 1 subcutaneous 0.65-mL injection | 185 |
| Total | 367 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Withdrew consent | 2 | 0 |
Baseline characteristics
| Characteristic | ZOSTAVAX™ With PGSU | ZOSTAVAX™ With PGS | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 9.25 | 63.2 years STANDARD_DEVIATION 8.44 | 63.35 years STANDARD_DEVIATION 8.83 |
| Race/Ethnicity Asian | 6 participants | 6 participants | 12 participants |
| Race/Ethnicity Asiatic | 1 participants | 4 participants | 5 participants |
| Race/Ethnicity Black | 19 participants | 15 participants | 34 participants |
| Race/Ethnicity Hispanic American | 30 participants | 34 participants | 64 participants |
| Race/Ethnicity Indian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity Native American | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity White | 124 participants | 126 participants | 250 participants |
| Sex: Female, Male Female | 97 Participants | 106 Participants | 203 Participants |
| Sex: Female, Male Male | 85 Participants | 79 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 180 | 84 / 183 |
| serious Total, serious adverse events | 1 / 180 | 0 / 183 |
Outcome results
Primary
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 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.
Time frame: 4 weeks
Population: The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ZOSTAVAX™ With PGSU | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 717.5 gpELISA units/mL |
| ZOSTAVAX™ With PGS | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 844.9 gpELISA units/mL |
Secondary
Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 4 weeks
Population: All vaccinated subjects with safety follow-up are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZOSTAVAX™ With PGSU | Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | Without vaccine related SAEs | 180 Participants |
| ZOSTAVAX™ With PGSU | Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | With vaccine related SAEs | 0 Participants |
| ZOSTAVAX™ With PGS | Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | With vaccine related SAEs | 0 Participants |
| ZOSTAVAX™ With PGS | Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination | Without vaccine related SAEs | 183 Participants |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination
Time frame: From prevaccination (baseline) to 4 weeks postvaccination
Population: The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ZOSTAVAX™ With PGSU | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | 2.6 gpELISA units/mL |
| ZOSTAVAX™ With PGS | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | 2.9 gpELISA units/mL |