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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 7 days after the second dose (days 61 to 68)
Awards & highlights
Study Summary
This trial is testing a vaccine for Staphylococcus aureus, both in healthy adults and in adults who have recently had a skin or soft tissue infection from this bacteria. The trial will assess the safety, immunogenicity (ability to produce immunity), and efficacy (ability to prevent infection) of the vaccine.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 68 (7 days after the second dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 68 (7 days after the second dose)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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).
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,766 Previous Clinical Trials
8,104,954 Total Patients Enrolled
2 Trials studying Soft Tissue Infections
233 Patients Enrolled for Soft Tissue Infections
GSK Clinical TrialsStudy DirectorGlaxoSmithKlline
3,596 Previous Clinical Trials
6,143,706 Total Patients Enrolled
1 Trials studying Soft Tissue Infections
195 Patients Enrolled for Soft Tissue Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 64 years old and ready for my first vaccination.I am taking long-term immune system altering medications.I am a woman who cannot become pregnant.I have a condition that causes prolonged bleeding.I have uncontrolled neurological disorders or seizures.I am a woman who can have children and have used birth control effectively.I cannot have shots or blood taken due to my health condition.I am not on long-term immune system drugs.I have a serious long-term illness.I have been vaccinated against S. aureus.I have health issues that could increase my surgery risks.I am either male or female.I am between 18 and 50 years old.I am currently undergoing or have undergone cytotoxic therapy.I haven't received immunoglobulins or blood products in the last 3 months.I do not have major lung, heart, liver, kidney issues, cancer, type 1 diabetes, or uncontrolled type 2 diabetes.I understand the study procedures and what this study involves.I am at high risk for serious skin infections.I am healthy but suspect or have confirmed a skin infection caused by S. aureus.I am between 18 and 64 years old.I am a woman who cannot become pregnant.I do not have an active illness at the time of screening or injection.I am healthy and can participate in the initial safety assessment of a new treatment.Subjects who can and will comply with the requirements of the protocol.I am between 18 and 50 years old and have not yet received my first vaccination.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group 1b
- Group 2: Placebo Group 2b
- Group 3: Half dose adj Group 3a
- Group 4: Placebo Group 3b
- Group 5: Full dose adj Group 4a
- Group 6: Placebo Group 4b
- Group 7: Half dose non-adj Group 1a
- Group 8: Full dose non-adj Group 2a
- Group 9: Vaccine Group 5a
- Group 10: Placebo Group 5b
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Soft Tissue Infections Patient Testimony for trial: Trial Name: NCT04420221 — Phase 2
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