*STAPH AUREUS BIOCONJ-001 STG

• Research type

  Research Study

• Full title

  A Phase I/II, observer-blind, randomised, placebo-controlled study to assess safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine when administered to healthy adults (dose-escalation) and to adults 18 to 64 years of age with a recent S. aureus skin and soft tissue infection (SSTI).

• IRAS ID

  1004912

• Contact name

• Contact email

  GSKClinicalSupportHD@gsk.com

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2021-006215-29

• Clinicaltrials.gov Identifier

  NCT04420221

• Research summary

  Staphylococcus aureus (S. aureus) is a bacterium that can cause a range of different infections including sores, blisters and boils, surgical wound infections and infections of the lungs (pneumonia). S. aureus can also cause other serious infections such as blood poisoning (sepsis) which can lead to damage of many organs. Some forms of S. aureus respond well to antibiotics, whereas others demonstrate antibiotic resistance. S. aureus is among the bacteria with the highest levels of antibiotic resistance globally. Currently there is no vaccine available to prevent S. aureus.
  This research study is to test a new vaccine which has been made to prevent recurrent infections of the skin and soft tissues caused by S. aureus. The study has 5 groups. Groups 1 to 4 consist of healthy participants and in these groups, the aim is to better understand the safety of the vaccine. In each of these study groups, 6 participants receive the study vaccine and 2 participants receive a “dummy” injection which contains saline solution (called a placebo). Enrolment into this phase of the study is already complete.
  The second phase of this study includes Group 5 who are participants with recent infection of the skin and soft tissues caused by S. aureus. Here, the aim is to understand the safety of the vaccine and how well it works in preventing recurrence of infections of the skin and soft tissues caused by S. aureus.
  Eligible participants for group 5 will have a screening period to confirm S.aureus infection. Once the infection has resolved, they will be randomly placed to receive either 2 doses of the experimental S. aureus vaccine or 2 doses of a placebo, given 2 months apart. For these participants, approximately 6 site visits and 5 phone calls with the clinic will be required over a period of about 14 months. Visits can include a physical exam, blood tests, vaccination and review of an electronic diary device which will be provided to record any side effects.

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• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  22/SC/0292

• Date of REC Opinion

  6 Jul 2022

• REC opinion

  Further Information Favourable Opinion