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

Purpose

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.

Condition	Intervention	Phase
Staphylococcus Aureus Bacteremia Mediastinitis	Biological: V710 Biological: Placebo	Phase 2 Phase 3


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

Resource links provided by NLM:

Drug Information available for: Staphylococcus aureus

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection [ Time Frame: Up to 90 days after surgery ] [ Designated as safety issue: No ]
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.
Incidence Rate of Vaccine-related Serious Adverse Experiences [ Time Frame: Up to 360 days after surgery ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Number of Participants With Invasive Staphylococcus Aureus Infection [ Time Frame: Up to 90 days after surgery ] [ Designated as safety issue: No ]
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.
Number of Participants With Surgical-site Staphylococcus Aureus Infection [ Time Frame: Up to 90 days after surgery ] [ Designated as safety issue: No ]
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.


Enrollment:	8031
Study Start Date:	December 2007
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: V710 60 µg	Biological: V710 0.5-mL single injection of V710 (60 µg) Other Name: Merck 0657nI Staphylococcus aureus vaccine
Placebo Comparator: Placebo	Biological: Placebo 0.5-mL single injection of matching placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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.

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fowler VG, Allen KB, Moreira ED, Moustafa M, Isgro F, Boucher HW, Corey GR, Carmeli Y, Betts R, Hartzel JS, Chan IS, McNeely TB, Kartsonis NA, Guris D, Onorato MT, Smugar SS, DiNubile MJ, Sobanjo-ter Meulen A. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial. JAMA. 2013 Apr 3;309(13):1368-78. doi: 10.1001/jama.2013.3010.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00518687 History of Changes
Other Study ID Numbers:	V710-003 2007_523
Study First Received:	August 17, 2007
Results First Received:	October 2, 2012
Last Updated:	October 1, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Bacteremia Mediastinitis Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation	Pathologic Processes Mediastinal Diseases Thoracic Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016