CompletedPhase 2

Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) 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)

226 participantsStarted 2022-11-16

Plain-language summary

The study evaluates the safety, immunogenicity, and efficacy of the GSK S. aureus candidate vaccine (GSK3878858A) when administered to two groups: healthy adults (dose-escalation phase) and adults aged 18 to 64 years with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase, the safety and immunogenicity of four different vaccine compositions are assessed in healthy adults. Once safety has been established in this phase, the second phase, known as the proof of principle (PoP) phase, will assess the safety, immunogenicity, and efficacy of the final vaccine composition in adults with a recent SSTI.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All participants must satisfy all the following criteria at study entry: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. * Participant satisfying screening requirements. * Participants who, after the nature of the study has been explained to them, have shown adequate comprehension of the study procedures and knowledge of study. * A male or female * Dose escalation and safety lead-in phase: Aged between 18 and 50 years of age, inclusive, at the time of first vaccination. * PoP phase: Aged between 18 and 64 years of age, inclusive, at the time of first vaccination. * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 30 days prior to vaccination, * has a negative pregnancy test on the day of enrolment, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Additional inclusion criteria only …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)

PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)

Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)

PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)

Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination

Timeframe: During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)

Trial details

NCT IDNCT04420221

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-12

Results submitted2025-03-12

View on ClinicalTrials.gov More Infections, Soft Tissue trials