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Completed

NCT Number: NCT00822757

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

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: V710

Biological

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

Comparator: Placebo

Biological

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

Primary outcomes

  1. Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).

    Time frame: Prevaccination to 14 days postvaccination

    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).

Other outcomes

  1. GMFR by Age

    Time frame: Prevaccination to 14 days postvaccination

    Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)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 0657nI 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) pre/14 days postvac.

  2. GMFR in Antibody Concentration From Baseline

    Time frame: Prevaccination to Days 10, 14, 28, and 84 postvaccination

    An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 14, 2009
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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