Jean Brown Research Announces Participation in a Phase II/III Clinical Trial of Investigational Vaccine Used to Prevent Infection in Cardiothoracic Surgery Patients
Jean Brown Research Announces Its Participation in a Phase II/III Clinical Trial of an Investigational Vaccine Used to Prevent Staphylococcus Aureus Infection in Patients Undergoing Cardiothoracic Surgery.
Salt Lake City, UT, May 19, 2010 --(PR.com)-- Jean Brown Research is pleased to announce that it has been selected as a study site for a clinical trial of an investigational vaccine to prevent Staphylococcus aureus (S. aureus) infection in patients undergoing cardiothoracic surgery.
About Hospital‐Acquired Infection and Staphylococcus aureus
Hospital‐acquired infection is a major health challenge worldwide because it often prolongs hospital stay and can lead to serious complications including death. The most common cause of hospital‐ acquired infection is S. aureus, a bacterium comprising several strains including methicillin‐resistant S. aureus (MRSA). S. aureus is the main pathogen responsible for infection associated with medical procedures and causes both wound infection and bacteremia, a life‐threatening infection of the blood.
Within the setting of cardiothoracic surgery S. aureus is even more concerning as these patients can develop surgical site infection including mediastinitis, a serious infection of the area between the lungs (mediastinum).
Several strains of S. aureus, including MRSA, are resistant to antibiotics making it extremely difficult to prevent and treat these infections. Currently, no vaccine exists to prevent S. aureus infection. Therefore, a vaccine that could be used prophylatically may confer important therapeutic benefits to patients who are at risk of developing a life‐threatening S. aureus infection.
About the Drug
V710 is a novel vaccine being developed by Merck & Co., Inc. to prevent serious hospital‐acquired infections caused by S. aureus such as bacteremia and mediastinitis. Animal studies and early clinical trials have showed promising results for the vaccine. In animal studies, V710 conferred protection against all subtypes of S. aureus bacterium, including MRSA. A recent Phase I study of V710 in more than 120 healthy volunteers showed that the vaccine was immunogenic, safe, and generally well tolerated. A study of V710 in patients with end‐stage kidney disease who are receiving hemodialysis is currently underway.
About the Study
This Phase II/III study is being conducted to investigate the safety and immune response of a single dose of V710 vaccine in adult patients undergoing elective cardiothoracic surgery who are at risk of infection. This study, which is intended to enroll more than 8000 subjects, is being conducted at more than 60 study sites located throughout North America, Central America, South America, Europe, and Asia. It is anticipated that the results from this study will be used to support a filing with the FDA for product approval in the United States.
About Jean Brown Research
Based in Salt Lake City, Utah, Jean Brown Research is a privately held, specialty research group recognized worldwide for its experience and 20 year history in clinical research. Jean Brown Research provides superior customer service, proficiency, innovation, and commitment for every clinical trial no matter how small or large. Our industry reputation arises from our unparalleled expertise in clinical research and our ability to consistently deliver quality results on time, every time. For more information about Jean Brown Research, please contact 801.261.2000 or visit www.jeanbrownresearch.com.
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About Hospital‐Acquired Infection and Staphylococcus aureus
Hospital‐acquired infection is a major health challenge worldwide because it often prolongs hospital stay and can lead to serious complications including death. The most common cause of hospital‐ acquired infection is S. aureus, a bacterium comprising several strains including methicillin‐resistant S. aureus (MRSA). S. aureus is the main pathogen responsible for infection associated with medical procedures and causes both wound infection and bacteremia, a life‐threatening infection of the blood.
Within the setting of cardiothoracic surgery S. aureus is even more concerning as these patients can develop surgical site infection including mediastinitis, a serious infection of the area between the lungs (mediastinum).
Several strains of S. aureus, including MRSA, are resistant to antibiotics making it extremely difficult to prevent and treat these infections. Currently, no vaccine exists to prevent S. aureus infection. Therefore, a vaccine that could be used prophylatically may confer important therapeutic benefits to patients who are at risk of developing a life‐threatening S. aureus infection.
About the Drug
V710 is a novel vaccine being developed by Merck & Co., Inc. to prevent serious hospital‐acquired infections caused by S. aureus such as bacteremia and mediastinitis. Animal studies and early clinical trials have showed promising results for the vaccine. In animal studies, V710 conferred protection against all subtypes of S. aureus bacterium, including MRSA. A recent Phase I study of V710 in more than 120 healthy volunteers showed that the vaccine was immunogenic, safe, and generally well tolerated. A study of V710 in patients with end‐stage kidney disease who are receiving hemodialysis is currently underway.
About the Study
This Phase II/III study is being conducted to investigate the safety and immune response of a single dose of V710 vaccine in adult patients undergoing elective cardiothoracic surgery who are at risk of infection. This study, which is intended to enroll more than 8000 subjects, is being conducted at more than 60 study sites located throughout North America, Central America, South America, Europe, and Asia. It is anticipated that the results from this study will be used to support a filing with the FDA for product approval in the United States.
About Jean Brown Research
Based in Salt Lake City, Utah, Jean Brown Research is a privately held, specialty research group recognized worldwide for its experience and 20 year history in clinical research. Jean Brown Research provides superior customer service, proficiency, innovation, and commitment for every clinical trial no matter how small or large. Our industry reputation arises from our unparalleled expertise in clinical research and our ability to consistently deliver quality results on time, every time. For more information about Jean Brown Research, please contact 801.261.2000 or visit www.jeanbrownresearch.com.
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Contact
Jean Brown Research
Matt Longson
(801) 261-4594
www.jeanbrownresearch.com
Matt Longson
(801) 261-4594
www.jeanbrownresearch.com
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