ABOUT THE STRIVE STUDY

Learn more about the study and eligibility to participate.

What is this study about?

  • To evaluate the safety and efficacy of an investigational vaccine when administered to adults undergoing a spinal fusion surgical procedure.
  • To investigate whether a single vaccination given 10-60 days before spinal surgery can prevent Staphylococcus aureus (staph) infections.

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Prior to making a new vaccine available to doctors or their patients:

  • Drug companies must test the investigational vaccine in a series of clinical research trials.
  • The safety and tolerability of this current investigational vaccine for Staphylococcus aureus have been studied in healthy adult subjects in two previous clinical trials.
  • The next step is to study the safety and efficacy of this investigational vaccine in patients planning a spinal fusion surgical procedure.

This study is planning to enroll:

  • 2,600 adults in the US, Canada, and Europe
  • Ages 18 to 85 years of age
  • Who are scheduled to have spinal fusion surgery

The information collected from this study may help in the development of a vaccine to prevent disease caused by Staphylococcus aureus.

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What is Staphylococcus aureus?

Skin is the body’s natural barrier to infection.

When the skin is opened for surgery, it is possible for bacteria (germs) to enter the wound and cause an infection.

  • These types of infections are known as surgical site and bloodstream infections.
  • About 1 to 3 people in every 100 develop a surgical site infection after spinal surgery.
  • One of the most common germs found in these infections is Staphylococcus aureus, also known as aureus, staph, staph aureus, MRSA, MSSA or golden staph.

Who can take part in the study?

You may be eligible for this study if you are:

  • 18 to 85 years of age
  • Scheduled to undergo an elective spinal fusion procedure
  • Available for the entire duration of the study
  • Willing and able to comply with study procedures and sign an informed consent document
  • Willing to complete health questions, a physical exam and required tests to determine study qualification

If you do qualify, you will be asked to:

  • Attend 5 study clinic visits and 1 telephone check-up visit over a 6 to 8 month period (visits for the study will most likely coincide with the visits that are scheduled after your surgery)
  • Receive a single one-time vaccination with either SA4Ag or placebo (a liquid that looks like the vaccine but has no active ingredients) 10 to 60 days before your surgery
  • Record any vaccine reactions in an electronic diary each day for 10 days after vaccination
  • Give a blood sample at each study visit
  • Have your nose and throat wiped with a cotton swab to collect study lab samples at each study visit
  • Attend the study clinic for follow-up appointments if needed
  • Use birth control to prevent pregnancy for the study duration for subjects of childbearing potential

Will it cost anything to participate?

No, all study vaccine and study-related procedures are provided at no cost to eligible participants. You will also be offered reasonable reimbursement for travel and expenses.

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Informative video about Staphylococcus aureus, vaccines and the Strive Study.

Take a moment now to learn more through this educational video.

Talk to your surgeon to see if this study is suitable for you

If you are interested in participating in this study or would like more information, please visit the Site Locations page to find the site contact information for a study location convenient to you.

Find Locations

NOTE: Please contact the study site as soon as possible if you are considering participating in this study as study participants need to receive the study vaccine 10 to 60 days prior to surgery to meet the study requirements.

STUDY LOCATIONS
STUDY LOCATIONS

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CLINICAL TRIAL INFORMATION
CLINICAL TRIAL INFORMATION

Learn more about how clinical research trials work

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ADDITIONAL RESOURCES
ADDITIONAL RESOURCES

Information related to Staphylococcus aureus

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