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

NCT00518687 | Terminated Phase 2 Results DMC

• 2 other identifiers: V710-0032007_523
• Study Type: interventional
• Target: 8,031
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Staphylococcus Aureus; Bacteremia; Mediastinitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Number of Participants With Invasive Staphylococcus Aureus Infection

  Up to 90 days after surgery

• Number of Participants With Surgical-site Staphylococcus Aureus Infection

  Up to 90 days after surgery

Study Arms (2)

V710 60 µg

EXPERIMENTAL

Biological: V710

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

V710 BIOLOGICAL

0.5-mL single injection of V710 (60 µg)

Also known as: Merck 0657nI Staphylococcus aureus vaccine

V710 60 µg

Placebo BIOLOGICAL

0.5-mL single injection of matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23549582 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Bacteremia; Mediastinitis

Interventions

V710 vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 21, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 2, 2015
• Results First Posted: November 5, 2012

Record last verified: 2015-10