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

NCT00822757 | Completed Phase 1 Results

• 2 other identifiers: V710-0042007_531
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

study in healthy subjects

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• GMFR by Age

  Prevaccination to 14 days postvaccination

• GMFR in Antibody Concentration From Baseline

  Prevaccination to Days 10, 14, 28, and 84 postvaccination

Study Arms (2)

1

EXPERIMENTAL

V710

Biological: Comparator: V710

2

PLACEBO COMPARATOR

Placebo

Biological: Comparator: placebo

Interventions

Comparator: V710 BIOLOGICAL

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

1

Comparator: placebo BIOLOGICAL

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

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.

  PMID: 22192849 RESULT

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: August 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 2, 2015
• Results First Posted: November 21, 2011

Record last verified: 2015-10