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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)

Primary Purpose

Infections, Soft Tissue

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sa-5Ag half dose non-adjuvanted
Sa-5Ag full dose non-adjuvanted
Sa-5Ag half dose adjuvanted
Sa-5Ag full dose adjuvanted
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Soft Tissue focused on measuring S. aureus, skin and soft tissue infection, first time in human, S. aureus vaccine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

  • Subjects 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 subject prior to performance of any study specific procedure.
  • Subject satisfying screening requirements.
  • Subjects 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 subjects 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 subjects of childbearing potential may be enrolled in the study, if the subject:

    • 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 subjects to be enrolled in the dose-escalation safety lead-in screening epoch:

- Healthy subjects as established by medical history, clinical examination and laboratory assessment.

Additional inclusion criteria only for subjects to be enrolled in the PoP screening epoch:

- Healthy subjects 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 subjects 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 subjects 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 subjects have to be treated until clinical resolution of the culture confirmed SSTI caused by S. aureus. These subjects 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.

Exclusion Criteria:

All subjects at study entry

  • 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)
  • 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 subject 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 subjects 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 subject'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 subject 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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Half dose non-adj Group 1a

Placebo Group 1b

Full dose non-adj Group 2a

Placebo Group 2b

Half dose adj Group 3a

Placebo Group 3b

Full dose adj Group 4a

Placebo Group 4b

Vaccine Group 5a

Placebo Group 5b

Arm Description

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.

Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.

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

Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.

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.

Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.

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)

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).

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).

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).

Outcomes

Primary Outcome Measures

Number of participants with solicited local adverse events (AEs) (any, grade 3)
The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).
Number of participants with solicited local adverse events (AEs) (any, grade 3)
The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimeters [mm]).
Number of participants with solicited general AEs (any, grade 3)
The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general 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.
Number of participants with solicited general AEs (any, grade 3)
The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general 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.
Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)
Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)
Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)
Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)
Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)
Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)
Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values
The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values
The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.

Secondary Outcome Measures

Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI
This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the second dose.
Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI
This co-secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the first dose.

Full Information

First Posted
June 4, 2020
Last Updated
August 4, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04420221
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
March 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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). In the dose-escalation safety lead-in phase in healthy adults safety and immunogenicity of 4 different compositions is assessed. After safety has been shown in this phase, in the second phase, proof of principle (PoP) phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the final composition of the vaccine is assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Soft Tissue
Keywords
S. aureus, skin and soft tissue infection, first time in human, S. aureus vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
632 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Half dose non-adj Group 1a
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group 1b
Arm Type
Placebo Comparator
Arm Description
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
Arm Title
Full dose non-adj Group 2a
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Group 2b
Arm Type
Placebo Comparator
Arm Description
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
Arm Title
Half dose adj Group 3a
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group 3b
Arm Type
Placebo Comparator
Arm Description
Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.
Arm Title
Full dose adj Group 4a
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo Group 4b
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Vaccine Group 5a
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo Group 5b
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Sa-5Ag half dose non-adjuvanted
Intervention Description
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Sa-5Ag full dose non-adjuvanted
Intervention Description
1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Sa-5Ag half dose adjuvanted
Intervention Description
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Sa-5Ag full dose adjuvanted
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
Primary Outcome Measure Information:
Title
Number of participants with solicited local adverse events (AEs) (any, grade 3)
Description
The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).
Time Frame
During 7 days after the first dose (Days 1 to 8)
Title
Number of participants with solicited local adverse events (AEs) (any, grade 3)
Description
The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimeters [mm]).
Time Frame
During 7 days after the second dose (Days 61 to 68)
Title
Number of participants with solicited general AEs (any, grade 3)
Description
The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general 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.
Time Frame
During 7 days after the first dose (Days 1 to 8)
Title
Number of participants with solicited general AEs (any, grade 3)
Description
The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general 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.
Time Frame
During 7 days after the second dose (Days 61 to 68)
Title
Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)
Description
Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Time Frame
During 30 days after the first dose (Days 1 to 31)
Title
Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)
Description
Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Time Frame
During 30 days after the second dose (Days 61 to 91)
Title
Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)
Description
Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Time Frame
Throughout the study period [from Day 1 (day of vaccination) until Day 366
Title
Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)
Description
Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Time Frame
Throughout the study period [from Day 1 (day of vaccination) until Day 426
Title
Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)
Description
Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Time Frame
Throughout the study period [from Day 1 (day of vaccination) until Day 366
Title
Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)
Description
Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.
Time Frame
Throughout the study period [from Day 1 (day of vaccination) until Day 426
Title
Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values
Description
The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
Time Frame
At Day 8 (7 days after the first dose)
Title
Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values
Description
The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.
Time Frame
At Day 68 (7 days after the second dose)
Secondary Outcome Measure Information:
Title
Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI
Description
This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the second dose.
Time Frame
Starting from Day 75 (i.e.14 days after the second dose) up to Day 426 (12 months after the second dose).
Title
Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI
Description
This co-secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the first dose.
Time Frame
Starting from Day 15 (i.e. 14 days after the first dose) up to Day 426 (12 months after the second dose).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All subjects must satisfy all the following criteria at study entry: Subjects 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 subject prior to performance of any study specific procedure. Subject satisfying screening requirements. Subjects 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 subjects 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 subjects of childbearing potential may be enrolled in the study, if the subject: 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 subjects to be enrolled in the dose-escalation safety lead-in screening epoch: - Healthy subjects as established by medical history, clinical examination and laboratory assessment. Additional inclusion criteria only for subjects to be enrolled in the PoP screening epoch: - Healthy subjects 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 subjects 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 subjects 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 subjects have to be treated until clinical resolution of the culture confirmed SSTI caused by S. aureus. These subjects 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. Exclusion Criteria: All subjects at study entry 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) 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 subject 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 subjects 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 subject'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 subject 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKlline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
GSK Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
GSK Investigational Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
GSK Investigational Site
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
GSK Investigational Site
City
Darlinghurst, Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Fortitude Valley
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
GSK Investigational Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
GSK Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
GSK Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
GSK Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
GSK Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
GSK Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380061
Country
India
Facility Name
GSK Investigational Site
City
Shivajinagar,Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Facility Name
GSK Investigational Site
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
400606
Country
India
Facility Name
GSK Investigational Site
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208002
Country
India
Facility Name
GSK Investigational Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221007
Country
India
Facility Name
GSK Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700016
Country
India
Facility Name
GSK Investigational Site
City
Lucknow
ZIP/Postal Code
226000
Country
India
Facility Name
GSK Investigational Site
City
Nagpur
ZIP/Postal Code
440003
Country
India
Facility Name
GSK Investigational Site
City
Nagpur
ZIP/Postal Code
441108
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
GSK Investigational Site
City
Nawton
ZIP/Postal Code
3200
Country
New Zealand
Facility Name
GSK Investigational Site
City
Nelson
ZIP/Postal Code
7011
Country
New Zealand
Facility Name
GSK Investigational Site
City
New Lynn
ZIP/Postal Code
0600
Country
New Zealand
Facility Name
GSK Investigational Site
City
Otahuhu
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-851
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Facility Name
GSK Investigational Site
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
00-215
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
01-142
Country
Poland
Facility Name
GSK Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
GSK Investigational Site
City
Durban
State/Province
KwaZulu- Natal
ZIP/Postal Code
4052
Country
South Africa
Facility Name
GSK Investigational Site
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2QW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com

Learn more about this trial

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)

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