Infections, Soft TissuePhase 2NCT04420221

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)

A Phase 2 study testing Sa-5Ag half dose non-adjuvanted, Sa-5Ag full dose non-adjuvanted and Sa-5Ag half dose adjuvanted in people with Infections, Soft Tissue, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Soft Tissue
What is being tested?: Sa-5Ag half dose non-adjuvanted, Sa-5Ag full dose non-adjuvanted and Sa-5Ag half dose adjuvanted
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 226 participants
Where: No sites listed yet
Study dates: 16 Nov 2022to 12 Mar 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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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 for participants to be enrolled in the dose-escalation safety lead-in screening epoch:
Healthy participants as established by medical history, clinical examination and laboratory assessment.
Additional inclusion criteria only for participants to be enrolled in the PoP screening epoch:
Healthy participants as established by medical history and clinical examination before entering into the study with an ongoing SSTI suspected to be caused by S. aureus, as diagnosed by investigator (before randomization participants have to be treated until clinical resolution of culture confirmed SSTI caused by S. aureus). SSTI must be amenable to microbiological culturing per standard clinical practice (i.e. recovery of drainage sample from abscess or suppurative cellulitis).
OR
Healthy participants as established by medical history and clinical examination before entering into the study with an ongoing S. aureus SSTI (i.e. S. aureus is the most likely cause), as confirmed by a S. aureus positive culture performed outside the study procedures and not earlier than 30 days prior to Informed Consent Form signature. Before randomisation participants have to be treated until clinical resolution of the culture confirmed SSTI caused by S. aureus. These participants will be enrolled whether they have or have not already started specific treatment of the infection. In case they have not started the treatment, this will be then given in compliance with the standard medical practice for the management of S. aureus SSTIs and the choice and judgment of the most appropriate treatment will be applied by the investigator, outside the study procedures.

Who cannot join

All participants at study entry
Body mass index (BMI) >40 kg/m2
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Hypersensitivity to latex
Recurrent history of uncontrolled neurological disorders or seizures
History of potential immune-mediated disease (pIMD)

Show all 35Show fewer

Clinical conditions that in the investigator's opinion represent a contraindication to intramuscular vaccination and blood draws
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s) within 30 days before the first dose of study vaccine(s)/placebo (Day -29 to Day 1), or during the study period
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine/placebo dose
Cytotoxic therapy (e.g., medications used during cancer chemotherapy)
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)
Administration of immunoglobulins and/or any blood products or plasma derivatives within 3 months before the first dose of study vaccine or during the study period
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 15 days before the first dose and ending 15 days after the last dose of vaccine(s) administration with the exception of any non-adjuvanted influenza vaccine which may be administered ≥7 days before or after each study vaccination
In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Product Information.
Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device)
Received a vaccine against S. aureus
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after completion of the vaccination series
History of chronic alcohol consumption and/or drug abuse
Any study personnel or immediate dependents, family, or household member
All participants at the time of vaccination
Any clinically significant hematological (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet count and red blood cell count) and/or biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine) laboratory abnormality
Additional exclusion criteria applied only for dose-escalation safety lead-in
Any active or ongoing illness at screening or time of injection
History of any serious chronic or progressive disease according to the judgment of the investigator
Additional exclusion criteria applied only for PoP at study entry
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Major congenital defects, as assessed by the investigator
Acute or chronic, clinically significant pulmonary, cardiovascular*, hepatic or renal functional abnormality, neoplasm, diabetes type 1 and uncontrolled diabetes type 2*, as determined by physical examination or laboratory screening tests * Note: Well-controlled type 2 diabetes mellitus (HbA1c <7%) and well-controlled arterial hypertension (blood pressure <140/90 mmHg) can be considered for inclusion in the study.
Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study
Individuals at risk for severe or life-threatening SSTIs (e.g., lymphatic or venous insufficiency, liver and kidney disease, IV drug use, etc.)
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
Additional exclusion criteria applied only for PoP at vaccination
Microbiological test results of drainage suggest that the SSTI etiology could be other than infection with S. aureus

About this study

Official 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)

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.

Conditions: Infections, Soft Tissue
Being tested: Sa-5Ag half dose non-adjuvanted, Sa-5Ag full dose non-adjuvanted, Sa-5Ag half dose adjuvanted, Sa-5Ag full dose adjuvanted, Placebo
Keywords: S. aureus, skin and soft tissue infection, first time in human, S. aureus vaccine
Medical subject headings: Soft Tissue Infections, Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sa-5Ag half dose non-adjuvantedBiological
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
Sa-5Ag full dose non-adjuvantedBiological
1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
Sa-5Ag half dose adjuvantedBiological
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
Sa-5Ag full dose adjuvantedBiological
A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.
PlaceboBiological
One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo Groups 1 to 3 (Dose-escalation epoch) and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo Group 4 (Dose-escalation epoch) and Group PoP: Placebo, administered intramuscularly.

Study groups in NCT04420221
Study group	Role	What they receive
Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj)	Experimental	Participants received 1 dose of the half dose formulation of the vaccine on Day 1. Receives: Biological: Sa-5Ag half dose non-adjuvanted
Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj	Experimental	Participants received 1 dose of the full dose formulation of the vaccine on Day 1. Receives: Biological: Sa-5Ag full dose non-adjuvanted
Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj	Experimental	Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1. Receives: Biological: Sa-5Ag half dose adjuvanted
Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj	Experimental	Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61. Receives: Biological: Sa-5Ag full dose adjuvanted
Dose-escalation Safety Lead-in Epoch: Placebo	Placebo comparator	Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch. Receives: Biological: Placebo
Proof of Principle (PoP): Full dose Adj	Experimental	Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61. Receives: Biological: Sa-5Ag full dose adjuvanted
PoP: Placebo	Placebo comparator	Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
Measured: 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
The solicited administration site AEs assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
Measured: 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
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
Measured: 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
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever were assessed. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
Measured: 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
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
Measured: 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)
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
Measured: 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)
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Measured: From Day 1 to Day 366
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Measured: From Day 61 to Day 426 (post vaccination at Day 61)
PoP: Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Measured: From Day 1 to Day 426
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From Day 1 to Day 366
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From Day 61 to Day 426 (post vaccination at Day 61)
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From Day 1 to Day 426
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
The Biochemical parameters assessed were: Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and the Haematological parameters assessed were: Haemoglobin, white blood cells (WBC) decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Measured: On Day 8 compared to Baseline (Day 1)
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Measured: On Day 68 compared to Baseline (Day 61)
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Measured: On Day 8
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Measured: On Day 68

Secondary outcomes (3)

Number of Participants With at Least One Culture Confirmed Case of Recurrent Staphylococcus Aureus (S. Aureus) Skin and Soft Tissue Infection (SSTI) - Interim Analysis
An interim analysis was performed after 13 cases of recurrent SA-SSTI were reported following 14 days from the study intervention dose 2.
Measured: From Day 75 to Day 426
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
After encountering futility at the interim analysis, an EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the second dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
Measured: From Day 75 to Day 426
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
An EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the first dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
Measured: From Day 15 to Day 426

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 202212 Mar 2024

First posted9 Jun 2020
Study start16 Nov 2022
Primary completion12 Mar 2024
Study completion12 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, Soft TissueStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04420221
Sponsor's protocol ID: 208833
Other IDs: 2021-006215-29
Status last verified: Apr 2025
First submitted: 4 Jun 2020
Last updated: 8 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Athan E, Greenberg RN, Baker DA, Shah R, Dubhashi S, Badat A, Thurlow C, Schlessinger J, Wronski A, Zakrzewski M, Turner D, Bindi I, Basile V, Galletti B, Spensieri F, Brazzoli M, Zigon G, Cilio GL, Ranzato G, Lattanzi M, Pellegrini M; Staph aureus 208833 study group. Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted S. aureus Vaccine in Adults with Recent Skin And Soft Tissue Infections: An Observer-blind, Randomized, Placebo-controlled, Multinational Phase 1/2 Trial. Clin Infect Dis. 2026 Mar 9:ciag162. doi: 10.1093/cid/ciag162. Online ahead of print.
PubMed 41800789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT04420221
Acronym / sponsor ID: 208833
Conditions: Infections, Soft Tissue
Keywords: S. aureus, skin and soft tissue infection, first time in human, S. aureus vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Nov 2022 (actual)
Primary completion: 12 Mar 2024 (actual)
Study completion: 12 Mar 2024 (actual)
First posted: 9 Jun 2020 (actual)
Results: Posted 8 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj)	Experimental	Biological: Sa-5Ag half dose non-adjuvantedParticipants received 1 dose of the half dose formulation of the vaccine on Day 1.
Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj	Experimental	Biological: Sa-5Ag full dose non-adjuvantedParticipants received 1 dose of the full dose formulation of the vaccine on Day 1.
Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj	Experimental	Biological: Sa-5Ag half dose adjuvantedParticipants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj	Experimental	Biological: Sa-5Ag full dose adjuvantedParticipants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
Dose-escalation Safety Lead-in Epoch: Placebo	Placebo comparator	Biological: PlaceboParticipants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
Proof of Principle (PoP): Full dose Adj	Experimental	Biological: Sa-5Ag full dose adjuvantedParticipants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
PoP: Placebo	Placebo comparator	Biological: PlaceboParticipants were randomized to receive 2 doses of placebo on Day 1 and Day 61.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (19 listed)

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

Key exclusion criteria (35 listed)

All participants at study entry
Body mass index (BMI) >40 kg/m2
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Hypersensitivity to latex
Recurrent history of uncontrolled neurological disorders or seizures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sa-5Ag half dose non-adjuvanted1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.	Biological	Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj)
Sa-5Ag full dose non-adjuvanted1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.	Biological	Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj
Sa-5Ag half dose adjuvanted1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.	Biological	Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj
Sa-5Ag full dose adjuvantedA series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.	Biological	Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj, Proof of Principle (PoP): Full dose Adj
PlaceboOne dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo Groups 1 to 3 (Dose-escalation epoch) and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo Group 4 (Dose-escalation epoch) and Group PoP: Placebo, administered intramuscularly.	Biological	Dose-escalation Safety Lead-in Epoch: Placebo, PoP: Placebo

Primary outcome

Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Time frame: 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)
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Time frame: 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)
The solicited administration site AEs assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Time frame: 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)
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Time frame: 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)
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever were assessed. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Time frame: 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)
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Time frame: 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)
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
Time frame: From Day 1 to Day 366
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
Time frame: From Day 61 to Day 426 (post vaccination at Day 61)
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
PoP: Number of Participants With SAEs
Time frame: From Day 1 to Day 426
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
Time frame: From Day 1 to Day 366
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
Time frame: From Day 61 to Day 426 (post vaccination at Day 61)
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
Time frame: From Day 1 to Day 426
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Time frame: On Day 8 compared to Baseline (Day 1)
The Biochemical parameters assessed were: Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and the Haematological parameters assessed were: Haemoglobin, white blood cells (WBC) decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Time frame: On Day 68 compared to Baseline (Day 61)
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Time frame: On Day 8
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Time frame: On Day 68
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.

3 secondary outcomes

Number of Participants With at Least One Culture Confirmed Case of Recurrent Staphylococcus Aureus (S. Aureus) Skin and Soft Tissue Infection (SSTI) - Interim Analysis
Time frame: From Day 75 to Day 426
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
Time frame: From Day 75 to Day 426
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
Time frame: From Day 15 to Day 426

Results and safety

Results posted to the registry on 8 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)	6	6
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj	6	6
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj	6	6
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj	6	6
Dose-escalation Safety Lead-in Epoch: Placebo	8	8
Proof of Principle (PoP): Full Dose Adj	105	80
PoP: Placebo	89	79

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

Time frame: 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). Count of participants. Unit: Participants

Measure	Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj) n = 6	Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj n = 6	Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj n = 6	Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj n = 6	Dose-escalation Safety Lead-in Epoch: Placebo n = 8
Vaccination 1, Pain at injection site, Any	2	3	5	5	1
Vaccination 1, Pain at injection site, Severe	0	0	0	0	0
Vaccination 1, Redness at injection site, Any	0	1	0	2	0
Vaccination 1, Redness at injection site, >100 mm	0	0	0	0	0
Vaccination 1, Swelling at injection site, Any	0	0	0	1	0
Vaccination 1, Swelling at injection site, >100 mm	0	0	0	0	0
Vaccination 2, Pain at injection site, Any	–	–	–	6	0
Vaccination 2, Pain at injection site, Severe	–	–	–	0	0

Population analysed: The analysis was performed on Solicited Safety Set (SSS) which included all subjects who received at least 1 dose of the study treatment (Exposed Set) who have solicited safety data. Analysis is presented for Dose-escalation safety lead-in participants.

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

Measure	Proof of Principle (PoP): Full Dose Adj n = 102	PoP: Placebo n = 88
Vaccination 1, Pain at injection site, Any	56	11
Vaccination 1, Pain at injection site, Severe	2	0
Vaccination 1, Redness at injection site, Any	4	0
Vaccination 1, Redness at injection site, >100 mm	1	0
Vaccination 1, Swelling at injection site, Any	7	1
Vaccination 1, Swelling at injection site, >100 mm	2	1
Vaccination 2, Pain at injection site, Any	42	2
Vaccination 2, Pain at injection site, Severe	3	0

Population analysed: The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for PoP participants.

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

Measure	Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj) n = 6	Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj n = 6	Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj n = 6	Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj n = 6	Dose-escalation Safety Lead-in Epoch: Placebo n = 8
Vaccination 1, Abdominal Pain, Any	0	1	0	0	1
Vaccination 1, Abdominal Pain, Severe	0	0	0	0	0
Vaccination 1, Diarrhea, Any	0	1	1	1	0
Vaccination 1, Diarrhea, Severe	0	0	0	0	0
Vaccination 1, Fatigue, Any	1	2	3	3	2
Vaccination 1, Fatigue, Severe	0	0	0	0	0
Vaccination 1, Fever, Any	0	0	0	0	0
Vaccination 1, Fever (°C), > 40.0	0	0	0	0	0

Population analysed: The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for Dose-escalation safety lead-in participants.

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

Measure	Proof of Principle (PoP): Full Dose Adj n = 102	PoP: Placebo n = 88
Vaccination 1, Abdominal Pain, Any	6	6
Vaccination 1, Abdominal Pain, Severe	0	0
Vaccination 1, Diarrhea, Any	11	4
Vaccination 1, Diarrhea, Severe	0	0
Vaccination 1, Fatigue, Any	34	21
Vaccination 1, Fatigue, Severe	2	2
Vaccination 1, Fever, Any	4	1
Vaccination 1, Fever (°C), > 40.0	0	0

Population analysed: The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for PoP participants.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Dose-escalation Safety Lead-in Epoch: Placebo	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Proof of Principle (PoP): Full Dose Adj	5 of 103 (4.9%)	82 of 103 (79.6%)	0 of 103
PoP: Placebo	5 of 89 (5.6%)	60 of 89 (67.4%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41800789Athan E, Greenberg RN, Baker DA, Shah R, Dubhashi S, Badat A, Thurlow C, Schlessinger J, Wronski A, Zakrzewski M, Turner D, Bindi I, Basile V, Galletti B, Spensieri F, Brazzoli M, Zigon G, Cilio GL, Ranzato G, Lattanzi M, Pellegrini M; Staph aureus 208833 study group. Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted S. aureus Vaccine in Adults with Recent Skin And Soft Tissue Infections: An Observer-blind, Randomized, Placebo-controlled, Multinational Phase 1/2 Trial. Clin Infect Dis. 2026 Mar 9:ciag162. doi: 10.1093/cid/ciag162. Online ahead of print.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKlline

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sa-5Ag half dose non-adjuvanted, Sa-5Ag full dose non-adjuvanted and Sa-5Ag half dose adjuvanted in people with Infections, Soft Tissue, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination (time frame: 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)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.