What is the mechanism of action of this treatment?

Common treatments for soft tissue infections (STIs) caused by Staphylococcus aureus include antibiotics such as beta-lactams (e.g., penicillins and cephalosporins), which inhibit bacterial cell wall synthesis, and clindamycin, which inhibits protein synthesis by binding to the 50S ribosomal subunit. These treatments are crucial as they directly target and eliminate the bacterial pathogens causing the infection. The GSK S. aureus candidate vaccine aims to stimulate the immune system to recognize and combat Staphylococcus aureus, potentially reducing the incidence and severity of infections. This is particularly important for STI patients as it could provide a proactive approach to preventing infections, reducing reliance on antibiotics, and mitigating the risk of antibiotic resistance.

What side effects are associated with this type of intervention?

Common treatments for soft tissue infections, particularly those targeting Staphylococcus aureus, include antibiotics such as penicillin, cephalosporins, and vancomycin. Known side effects of these antibiotics can include gastrointestinal issues (nausea, vomiting, diarrhea), allergic reactions (rash, anaphylaxis), and, in the case of vancomycin, nephrotoxicity and ototoxicity. Vaccines or immunotherapies targeting Staphylococcus aureus, like the GSK candidate vaccine, may cause side effects such as injection site reactions (pain, redness, swelling), fever, fatigue, and muscle aches. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks of treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for soft tissue infections, including antibiotics such as vancomycin, daptomycin, and linezolid, which are effective against methicillin-resistant Staphylococcus aureus (MRSA). Additionally, newer agents like ceftaroline and delafloxacin have been approved for acute bacterial skin and skin structure infections (ABSSSI). These treatments primarily focus on direct antibacterial action rather than stimulating an immune response. The GSK S. aureus candidate vaccine represents a novel approach by aiming to enhance the body's immune response to prevent or mitigate infections caused by Staphylococcus aureus.

What other types of research exist?

Promising alternatives to the GSK S. aureus candidate vaccine for soft tissue infections include: 1) Pfizer's SA4Ag vaccine, which targets four S. aureus antigens and has shown promising results in early trials. 2) Monoclonal antibodies such as AR-301 (Salvecin) by Aridis Pharmaceuticals, which targets the alpha-toxin of S. aureus and has demonstrated efficacy in clinical trials. 3) Bacteriophage therapy, which uses viruses that specifically target and kill S. aureus bacteria, is also being explored as a novel treatment option.

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Cancer Vaccine

S. Aureus Vaccine for Soft Tissue Infections

Phase 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18 and 50 years of age, inclusive, at the time of first vaccination for dose escalation and safety lead-in phase

Healthy subjects for PoP screening epoch with ongoing SSTI suspected to be caused by S. aureus or ongoing S. aureus SSTI confirmed by culture

Must not have

Administration of long-acting immune-modifying drugs

Known bleeding diathesis or prolonged bleeding time condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 7 days after the first dose (days 1 to 8)

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, allergic reactions or other immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I am healthy but suspect or have confirmed a skin infection caused by S. aureus.

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I am between 18 and 64 years old.

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I am a woman who cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking long-term immune system altering medications.

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I have a condition that causes prolonged bleeding.

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I have uncontrolled neurological disorders or seizures.

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I cannot have shots or blood taken due to my health condition.

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I am not on long-term immune system drugs.

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I have been vaccinated against S. aureus.

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I am currently undergoing or have undergone cytotoxic therapy.

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I haven't received immunoglobulins or blood products in the last 3 months.

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I do not have major lung, heart, liver, kidney issues, cancer, type 1 diabetes, or uncontrolled type 2 diabetes.

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I am at high risk for serious skin infections.

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I do not have an active illness at the time of screening or injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 7 days after the second dose (days 61 to 68)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 7 days after the second dose (days 61 to 68)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 7 days after the second dose (days 61 to 68) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values

Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)

Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)

+3 more

Secondary study objectives

Staphylococcus aureus

Trial Design

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).

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for soft tissue infections (STIs) caused by Staphylococcus aureus include antibiotics such as beta-lactams (e.g., penicillins and cephalosporins), which inhibit bacterial cell wall synthesis, and clindamycin, which inhibits protein synthesis by binding to the 50S ribosomal subunit. These treatments are crucial as they directly target and eliminate the bacterial pathogens causing the infection. The GSK S. aureus candidate vaccine aims to stimulate the immune system to recognize and combat Staphylococcus aureus, potentially reducing the incidence and severity of infections. This is particularly important for STI patients as it could provide a proactive approach to preventing infections, reducing reliance on antibiotics, and mitigating the risk of antibiotic resistance.