Clinical trial NCT00518687: Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Staphylococcus Aureus
Bacteremia
Mediastinitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 8031
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
timeFrame: Up to 90 days after surgery
measure: Incidence Rate of Vaccine-related Serious Adverse Experiences
timeFrame: Up to 360 days after surgery
Secondary outcomes:
measure: Number of Participants With Invasive Staphylococcus Aureus Infection
timeFrame: Up to 90 days after surgery
measure: Number of Participants With Surgical-site Staphylococcus Aureus Infection
timeFrame: Up to 90 days after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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.