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)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    632
  • sponsor
    GlaxoSmithKline
Updated on 6 June 2022
abscess
drainage
cellulitis
hysterectomy
bilateral ovariectomy
Accepts healthy volunteers

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.

Details
Condition Infections, Soft Tissue
Treatment Placebo, Sa-5Ag half dose non-adjuvanted, Sa-5Ag full dose non-adjuvanted, Sa-5Ag half dose adjuvanted, Sa-5Ag full dose adjuvanted
Clinical Study IdentifierNCT04420221
SponsorGlaxoSmithKline
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

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
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
Dose escalation and safety lead-in phase: Aged between 18 and 50 years of age, inclusive, at the time of first vaccination
Female subjects of childbearing potential may be enrolled in the study, if the
PoP phase: Aged between 18 and 64 years of age, inclusive, at the time of first vaccination
has practiced adequate contraception for 30 days prior to vaccination
subject
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
Hypersensitivity to latex
Recurrent history of uncontrolled neurological disorders or seizures
History of potential immune-mediated disease (pIMD)
Cytotoxic therapy (e.g., medications used during cancer chemotherapy)
Received a vaccine against S. aureus
Pregnant or lactating female
History of chronic alcohol consumption and/or drug abuse
Any study personnel or immediate dependents, family, or household member
History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine
Additional exclusion criteria applied only for dose-escalation safety lead-in
Clinical conditions that in the investigator's opinion represent a contraindication to
Any active or ongoing illness at screening or time of injection
intramuscular vaccination and blood draws
Known bleeding diathesis or any condition that may be associated with a prolonged
Additional exclusion criteria applied only for PoP at study entry
bleeding time
Use of any investigational or non-registered product (drug, vaccine or medical device)
Major congenital defects, as assessed by the investigator
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
Additional exclusion criteria applied only for PoP at vaccination
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)
Female planning to become pregnant or planning to discontinue contraceptive
precautions before 2 months after completion of the vaccination series
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
History of any serious chronic or progressive disease according to the judgment of the
investigator
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination
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
Microbiological test results of drainage suggest that the SSTI etiology could be other
than infection with S. aureus
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