Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)

Study Overview
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Brief Summary
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This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Biological: Comparator: V710
* Biological: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age Good physical health based upon medical history and physical examination Willing and able to participate in the entire study duration Female subject with a negative urine pregnancy test immediately prior to study vaccination Exclusion Criteria: Chronic skin infections or a chronic skin condition (e.g. psoriasis) Serious S. aureus infection in the last 12 months Allergy to aluminum-containing substance taken in the body or to any other vaccine component Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days Participation in a prior V710 vaccine clinical study Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>V710 | Biological: Comparator: V710<br>* Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.<br>|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: placebo<br>* Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac). | Prevaccination to 14 days postvaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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study in healthy subjects