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). - STAPH AUREUS BIOCONJ-001 STG

GlaxoSmithKline Biologicals SA0 个研究点目标入组 632 人开始时间: 2022年3月9日最近更新: 2024年6月10日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals SA
入组人数: 632

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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).
•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 632
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•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 d

研究者

发起方

GlaxoSmithKline Biologicals SA

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