A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Subjects With Solicited General Symptoms
研究概览
简要总结
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Written informed consent obtained from the subject prior to performing any study specific procedure
- •A male or female between, and including, 18 and 45 years of age at the time of first vaccination
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Female subjects of non-childbearing potential may be enrolled in the study
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccina-tion, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
排除标准
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
- •Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before the first dose and ≥ 15 days after the last dose of study vaccine
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period
- •Blood donation within 4 months prior to study entry or planned blood donation at any time during the study
- •Previous vaccination against RSV
- •Previous vaccination with a recombinant simian or human adenoviral vaccine
- •Previous Bexsero or other vaccination against Neisseria meningitidis serogroup B
- •History of or current autoimmune disease
- •Family history of congenital or hereditary immunodefi-ciency
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •History of any neurological disorders or seizures
- •History of transient thrombocytopenia or neurological complications following any prior vaccination
- •Hypersensitivity to latex
- •Hypersensitivity to Bexsero's active substances or to any of its excipients
- •Allergic reaction to kanamycin
- •Any medical condition that in the judgment of the investi-gator would make intramuscular injection unsafe
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Acute disease and/or fever at the time of enrolment
- •Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by physical examination or laboratory screening tests
- •Malignancy within previous 5 years or lymphoproliferative disorders
- •Any clinically significant or any ≥ Grade 2 haematological laboratory abnormality
- •Body mass index > 40 kg/m2
- •Current alcohol and/or drug abuse
- •Pregnant or lactating female
- •Any other condition that the investigator judges may interfere with study procedures or findings
- •Planned move to a location that will prohibit participating in the trial until study end
研究组 & 干预措施
GSK3389245A_LD GROUP
Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose
干预措施: GSK3389245A_LD GROUP (Biological)
GSK3389245A_HD GROUP
Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose
干预措施: GSK3389245A_HD GROUP (Biological)
Bexsero Group
Subjects in this group will receive 2 doses, one month apart, of Bexsero
干预措施: Bexsero (Biological)
Placebo Group
Subjects in this group will receive 2 doses, one month apart, of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Solicited General Symptoms
时间窗: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\] gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
时间窗: From Day 1 to Day 60
Parameters analysed were ALT, activated partial thromboplastin time \[APTT\], AST, total bilirubin \[TB\], CRE, EOS, haemoglobin decrease \[HgD\], LYM, NEU, platelets \[PLA\], PT, white blood cells decrease \[WBCD\] and white blood cells increase \[WBCI\]. Assessed grades were: Unknown \[UG\], grade 0 \[G0\] = no grade, 1 \[G1\] = mild grade, 2 \[G2\] = moderate grade, 3 \[G3\] = severe grade, 4 \[G4\] = potentially life threatening and overall grading \[GTotal\]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: From Day 0 to Day 360
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Solicited Local Symptoms
时间窗: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
时间窗: At Day 360
Haematological/Biochemical parameters assessed were haemoglobin level \[HgL\], red blood cell \[RBC\], white blood cell \[WBC\], lymphocyte \[LYM\], neutrophil \[NEU\], eosinophil \[EOS\], reticulocyte \[RET\], platelet count \[PLC\], haptoglobin \[Hpg\], prothrombin time \[PT\] and partial thromboplastin time \[PTT\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine \[CRE\], lactate dehydrogenase \[LDH\] and bilirubin direct or total \[BLD/BLT\].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).
Number of Subjects With Unsolicited Adverse Events (AEs)
时间窗: During the 30-day (Days 0-29) post-vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
次要结局
- Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers(At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60))
- Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)(At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60))
- Number of Subjects With Haematological and Biochemical Results by Maximum Grade(From Day 1 up to Day 360)
- Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value(At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60))
- Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells(At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60))