S. Aureus Vaccine for Soft Tissue Infections
Recruiting at57 trial locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: GlaxoSmithKline
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial tests a new GSK vaccine for Staphylococcus aureus. It first checks safety in healthy adults, then tests effectiveness in adults with skin infections. The vaccine aims to help the body fight off these bacteria.
Research Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKlline
Eligibility Criteria
Adults aged 18-50 for initial phase and 18-64 with recent S. aureus skin infection for the second phase, who understand the study and can follow its procedures. Women must use contraception or be non-childbearing. Excludes those with certain medical conditions, drug abuse history, or on immune-modifying drugs.Inclusion Criteria
I am a woman who can have children and have used birth control effectively.
Subjects who can and will comply with the requirements of the protocol
I am either male or female.
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Exclusion Criteria
Microbiological test results suggesting SSTI etiology other than S. aureus for PoP at vaccination
Concurrent participation in another clinical study with exposure to investigational products
I am taking long-term immune system altering medications.
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Treatment Details
Interventions
- GSK3878858A (Cancer Vaccine)
Trial OverviewThe trial is testing a new vaccine (GSK3878858A) against S. aureus infections in two phases: first, different doses/compositions in healthy adults; second, efficacy in adults with recent S. aureus skin infections using the final vaccine composition.
Participant Groups
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Vaccine Group 5aExperimental Treatment1 Intervention
Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61).
Group II: Half dose non-adj Group 1aExperimental Treatment1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1.
Group III: Half dose adj Group 3aExperimental Treatment1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1.
Group IV: Full dose non-adj Group 2aExperimental Treatment1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1
Group V: Full dose adj Group 4aExperimental Treatment1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61)
Group VI: Placebo Group 1bPlacebo Group1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
Group VII: Placebo Group 2bPlacebo Group1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
Group VIII: Placebo Group 3bPlacebo Group1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
Group IX: Placebo Group 4bPlacebo Group1 Intervention
Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).
Group X: Placebo Group 5bPlacebo Group1 Intervention
Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
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Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School