A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: V212 Lot 3; Biological: V212 Lot 2; Biological: V212 Lot 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180295

V212-014

2014-001030-29 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 50 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

V212 Lot 1

Experimental group

Description:

Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart

Treatment:

Biological: V212 Lot 1

V212 Lot 2

Experimental group

Description:

Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart

Treatment:

Biological: V212 Lot 2

V212 Lot 3

Experimental group

Description:

Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart

Treatment:

Biological: V212 Lot 3