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

Merck Sharp & Dohme LLC51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Comparator: V710BIOLOGICAL

Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.

Comparator: placeboBIOLOGICAL

Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Prevaccination to 14 days postvaccination

Data from ClinicalTrials.gov

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