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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04420221




Registration number
NCT04420221
Ethics application status
Date submitted
4/06/2020
Date registered
9/06/2020

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2021-006215-29
Secondary ID [2] 0 0
208833
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Soft Tissue 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sa-5Ag half dose non-adjuvanted
Treatment: Other - Sa-5Ag full dose non-adjuvanted
Treatment: Other - Sa-5Ag half dose adjuvanted
Treatment: Other - Sa-5Ag full dose adjuvanted
Treatment: Other - Placebo

Experimental: Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj) - Participants received 1 dose of the half dose formulation of the vaccine on Day 1.

Experimental: Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj - Participants received 1 dose of the full dose formulation of the vaccine on Day 1.

Experimental: Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj - Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.

Experimental: Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj - Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.

Placebo comparator: Dose-escalation Safety Lead-in Epoch: Placebo - 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.

Experimental: Proof of Principle (PoP): Full dose Adj - Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.

Placebo comparator: PoP: Placebo - Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.


Treatment: Other: Sa-5Ag half dose non-adjuvanted
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.

Treatment: Other: Sa-5Ag full dose non-adjuvanted
1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.

Treatment: Other: Sa-5Ag half dose adjuvanted
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.

Treatment: Other: Sa-5Ag full dose adjuvanted
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.

Treatment: Other: Placebo
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Timepoint [2] 0 0
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)
Primary outcome [3] 0 0
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Timepoint [3] 0 0
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)
Primary outcome [4] 0 0
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Timepoint [4] 0 0
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)
Primary outcome [5] 0 0
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Timepoint [5] 0 0
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)
Primary outcome [6] 0 0
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Timepoint [6] 0 0
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)
Primary outcome [7] 0 0
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
Timepoint [7] 0 0
From Day 1 to Day 366
Primary outcome [8] 0 0
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
Timepoint [8] 0 0
From Day 61 to Day 426 (post vaccination at Day 61)
Primary outcome [9] 0 0
PoP: Number of Participants With SAEs
Timepoint [9] 0 0
From Day 1 to Day 426
Primary outcome [10] 0 0
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
Timepoint [10] 0 0
From Day 1 to Day 366
Primary outcome [11] 0 0
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
Timepoint [11] 0 0
From Day 61 to Day 426 (post vaccination at Day 61)
Primary outcome [12] 0 0
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
Timepoint [12] 0 0
From Day 1 to Day 426
Primary outcome [13] 0 0
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Timepoint [13] 0 0
On Day 8 compared to Baseline (Day 1)
Primary outcome [14] 0 0
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Timepoint [14] 0 0
On Day 68 compared to Baseline (Day 61)
Primary outcome [15] 0 0
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Timepoint [15] 0 0
On Day 8
Primary outcome [16] 0 0
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Timepoint [16] 0 0
On Day 68
Secondary outcome [1] 0 0
Number of Participants With at Least One Culture Confirmed Case of Recurrent Staphylococcus Aureus (S. Aureus) Skin and Soft Tissue Infection (SSTI) - Interim Analysis
Timepoint [1] 0 0
From Day 75 to Day 426
Secondary outcome [2] 0 0
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
Timepoint [2] 0 0
From Day 75 to Day 426
Secondary outcome [3] 0 0
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
Timepoint [3] 0 0
From Day 15 to Day 426

Eligibility
Key inclusion criteria
All participants must satisfy all the following criteria at study entry:

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

Additional inclusion criteria only 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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)
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/03/2024
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKlline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04420221