Herpes Zoster
Conditions
Brief summary
Primary objective: To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination. Secondary objectives: To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
Interventions
BIOLOGICALZOSTAVAX®
One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU
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
* Participant of either gender aged ≥50 years * Positive history of varicella or residence for \>30 years in a country with endemic VZV infection * All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination * Participant having signed the informed consent form prior to any study procedure
Exclusion criteria
* Febrile within 72 hours prior to vaccination * Prior history of Herpes Zoster clinically diagnosed by a physician * Previously received a varicella or zoster vaccine * Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination * Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study * Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study * Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study * Taking any non topical antiviral therapy with activity against herpesviruses. * On immunosuppressive therapy * Known or suspected immune dysfunction caused by a medical condition, or any other cause * History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin * Known active tuberculosis * Significant underlying illness preventing completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titre (GMT) of Varicella Antibodies | Predose (Day 0) and Day 28-35 Post Dose | Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0) | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | All Enrolled |
|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
Primary
Geometric Mean Titre (GMT) of Varicella Antibodies
Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Time frame: Predose (Day 0) and Day 28-35 Post Dose
Population: All vaccinated participants excluding those with any protocol deviation which may have interfered with the immunogenicity evaluation and excluding participants with herpes zoster onset before the post-vaccination blood sample
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All Enrolled | Geometric Mean Titre (GMT) of Varicella Antibodies | Predose | 215.8 gpELISA units/mL |
| All Enrolled | Geometric Mean Titre (GMT) of Varicella Antibodies | Postdose | 674.0 gpELISA units/mL |
95% CI: [2.6, 3.8]