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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00822757
First received: January 13, 2009
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: Comparator: V710
Biological: Comparator: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). [ Time Frame: Prevaccination to 14 days postvaccination ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • GMFR by Age [ Time Frame: Prevaccination to 14 days postvaccination ] [ Designated as safety issue: No ]
    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.

  • GMFR in Antibody Concentration From Baseline [ Time Frame: Prevaccination to Days 10, 14, 28, and 84 postvaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
V710
Biological: Comparator: V710
Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.
Placebo Comparator: 2
Placebo
Biological: Comparator: placebo
Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822757

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00822757     History of Changes
Other Study ID Numbers: V710-004, 2007_531
Study First Received: January 13, 2009
Results First Received: June 22, 2011
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
study in healthy subjects

ClinicalTrials.gov processed this record on August 28, 2014