None listed
Conditions
Interventions
Group 1 Type of group
Single injection of 0.5 mL (60 pg) of V710
Group name:Group 2 Type of group
Single injection of 0.5 mL of placebo (diluent of normal saline solution [0.9%]).
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is or is over 18 years of age. • The patient is scheduled to undergo cardiothoracic surgery that involves a complete middle stemotomy (which does not include heart transplant surgery) within 14 to 60 days after the vaccination. • The patient can understand all study procedures and agrees to participate in the study by providing written informed consent. • The patient intends to participate throughout the study period (ie, from postoperative day 90 for most patients, to postoperative day 360 for the subgroup of patients identified to be followed for an immune response to long term). • Potentially fertile female patients are required to have a negative pregnancy test in urine or serum immediately before vaccination in the study. Potentially fertile female patients must have been using an acceptable form of birth control for two weeks prior to enrollment, and agree to use an acceptable method of birth control for one month after vaccination. Acceptable methods of birth control include the use of hormonal contraceptives, an intrauterine device (IUD), a diaphragm with spermicide, a contraceptive sponge, tubal ligation, condoms, or abstinence.
Exclusion criteria
Exclusion criteria: • The patient develops an invasive infection caused by S. aureus (eg, bacteremia, endocarditis, pneumonia, mediastinitis, osteomyelitis, etc.) in the three months prior to entry into the study. • The underlying condition of the patient is sufficiently unstable that there is a realistic possibility (> 50%) that cardiothoracic surgery is necessary within 10 days after study entry / vaccination. • The patient is planning to undergo cardiothoracic surgery which does not involve a complete mid-stemotomy (ie, minimally invasive cardiothoracic surgery). • The patient is planning to undergo heart transplant surgery or debridement of the sternum to remedy an infection resulting from previous cardiothoracic surgery. • The patient has some type of ventricular assist device placed at the time of entering the study. • The patient has a history of anaphylaxis to any of the components of the vaccine. • The patient has previously received V710 (either in this study in a previous V710 study). • The patient has received any other investigational vaccine against S. aureus or any or any other antibody under investigation against S. aureus within 12 months prior to entry into the study. • The patient has a temperature of> 100.4 ° F (> 38.0 ° C), oral equivalent, within 48 hours before admission to the study. • The patient has received a live virus vaccine within 30 days prior to the administration of the study vaccine or is scheduled to receive any live virus vaccine within 30 days after the vaccination. • The patient has received any other authorized vaccine (including inactivated or recombinant vaccines) within 14 days prior to the administration of the study vaccine or is scheduled to receive another authorized vaccine (including non-live virus vaccines) within the 30 days after vaccination. • The patient received any immunoglobulin within 90 days prior to the study vaccination or is scheduled to receive this type of product at any time until postoperative day 90. • The patient has received treatment with systemic (intramuscular, oral or intravenous) corticosteroids (at an equivalent dose of prednisone of> 20 mg daily), another immunosuppressant drug (eg, calcineurin inhibitors, mycophenolate, azathioprine) or agents biological agents (eg, rituximab) in the 14 days prior to the study vaccination, or are expected to receive these drugs for a chronic medical condition at any time until postoperative day 90. • The patient has known or suspected impairment of immune function that includes, but not limited to, the following conditions: autoimmune disease, moderate / severe hepatic insufficiency or cirrhosis, renal failure or failure (under hemodialysis or peritoneal dialysis), deficiency of immunoglobulin or other congenital or acquired immunodeficiency, including HIV / AIDS. • The patient has a condition such as hemophilia, other severe coagulation disorders or a significantly impaired venous access, in which venipunctures or repeated injections pose more than minimal risk. • The patient is currently pregnant or giving laclar, or is planning to conceive at any time during the study period (until postoperative day 90). • The patient has a medical condition in which the expected survival is less than 90 days. • The patient has current evidence or recent history (within five years prior to admission to the study) of intravenous drug abuse. • The patient has participated in another clin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Bacteremia Caused by S. aureus: A case of bacteremia caused by S. aureus will be defined as> 1 positive blood culture for S. aureus (regardless of the presence of clinical symptoms). Measure:Proportion of patients with evidence of bacteremia caused by S. aureus and / or deep infections of the sternal surgical wound caused by S. aureus at any time until postoperative day 90 Timepoints:90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:an invasive infection caused by S. aureus includes bacteremia caused by S. aureus \ profuse infections of the sternal surgical wound caused by S. aureus (including mediastinitis); any other deep tissue, organ / space infection caused by S. aureus in another surgical site; or any other deep tissue infection caused by S. aureus (eg, osteomyelitis / septic arthritis, peritonitis, pneumonia, empyema caused by S. aureus, etc.). Measure:Incidence of invasive infection caused by S. aureus until postoperative day 90. Timepoints:Day 90 ; Outcome name:an infection of the surgical site will include incisional superficial, deep incisional or organ / space infections caused by S. aureus at the site of the stemotomy, the site (s) of vascular collection (donor) or any other site in which an intervention / surgical procedure was performed (eg, thoracic catheter placement site). Measure:Incidence of any infection of the surgical site caused by S. aureus until postoperative day 90. Timepoints:Day 90 | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed