Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

Bacteremia Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00518687
• Other study ID #: V710-003
• Secondary ID: 2007_523
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 17, 2007
• Last updated: October 1, 2015
• Start date: December 2007
• Est. completion date: August 2011

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8031
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.

• Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Exclusion Criteria:

• Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.

• A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.

• Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.

• Participant has any type of ventricular-assist device in place at the time of study entry.

• Participant has a history of anaphylaxis to any of the vaccine components.

• Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.

• Participant has a temperature of =100.4ºF (=38.0ºC), oral equivalent, within 48 hours prior to study vaccination.

• Participant has impairment of the immune system.

• Participant has a medical condition in which the expected survival is less than 90 days.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia
• Mediastinitis
• Staphylococcus Aureus

Intervention

Biological:
• V710
0.5-mL single injection of V710 (60 µg)
• Placebo
0.5-mL single injection of matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection	Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as =1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.	Up to 90 days after surgery	No
Primary	Incidence Rate of Vaccine-related Serious Adverse Experiences	Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.	Up to 360 days after surgery	Yes
Secondary	Number of Participants With Invasive Staphylococcus Aureus Infection	Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.	Up to 90 days after surgery	No
Secondary	Number of Participants With Surgical-site Staphylococcus Aureus Infection	Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.	Up to 90 days after surgery	No