Herpes Zoster
Conditions
Brief summary
The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.
Interventions
BIOLOGICALV212 Lot 1
Inactivated Varicella Zoster Virus vaccine
BIOLOGICALV212 Lot 2
Inactivated Varicella Zoster Virus vaccine
BIOLOGICALV212 Lot 3
Inactivated Varicella Zoster Virus vaccine
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Afebrile (\<=100.4 °F \[\<=38.0 °C\]) oral or equivalent on Day 1 before the first vaccination * Any underlying chronic illness that is not in stable condition * History of varicella, antibodies to VZV, or residence (for \>=30 years) in a country with endemic VZV infection * Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation * Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination
Exclusion criteria
* History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin) * Prior history of herpes zoster * History of receipt or expects to receive any varicella or zoster vaccine during the study period * Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination * Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study * Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination * Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study * Has participated in an investigational drug or vaccine study within 30 days before enrollment * Has any acute illness or significant underlying illness that may interfere with interpretation of the study * Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids * Has known or suspected immune dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers | 28 days postdose 4 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with a Serious Adverse Experience | Up to 28 days postdose 4 |
Outcome results
None listed