Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Number of Subjects With Biochemical and Haematological Levels Above Normal
研究概览
简要总结
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who the Investigator believes that they can and will comply with the requirements of the protocol.
- •A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject prior to any study procedure.
- •Subjects must be HIV-positive and must have:
- •received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening
- •documented suppressed HIV-1 RNA levels following HAART-treatment.
- •a protocol defined CD4+ T cell count at screening
- •If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.
- •Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
- •No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
- •No history of extrapulmonary TB.
- •No history of chemotherapy for TB.
排除标准
- •Any change in antiretroviral drug regimen within 12 weeks prior to screening.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
- •History of previous administration of experimental Mycobacterium tuberculosis vaccines.
- •History of previous exposure to experimental products containing components of the experimental vaccine.
- •Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
- •Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
- •Planned participation or participation in another experimental protocol during the study period.
- •A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.
- •Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.
- •History of allergic reactions or anaphylaxis to any vaccine.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of chronic alcohol consumption and/or drug abuse which in the Investigator's opinion would put the subject at risk.
- •Pregnant female, lactating female or female planning to become pregnant or stop contraception.
研究组 & 干预措施
Group B
Subjects receiving the adjuvant
干预措施: Control vaccine with the adjuvant system. (Biological)
Group C
Subjects receiving physiological saline
干预措施: Control vaccine with physiological saline (Biological)
Group A
Subjects receiving the candidate vaccine
干预措施: GSK's candidate Mycobacterium tuberculosis vaccine 692342 (Biological)
结局指标
主要结局
Number of Subjects With Biochemical and Haematological Levels Above Normal
时间窗: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophil \[EOS\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Solicited General Symptoms
时间窗: During the 7-day period (Days 0-6) post vaccination following each dose
Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. 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 Normal Biochemical and Haematological Levels
时间窗: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophil \[EOS\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Biochemical and Haematological Levels Below Normal
时间窗: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophil \[EOS\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Solicited Local Symptoms
时间窗: During the 7-day period (Days 0-6) post vaccination following each dose
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 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Number of Subjects With Unsolicited Adverse Events (AEs)
时间窗: During the 30-day period (Days 0-29) post vaccination
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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: During the entire study period, from Day 0 up to Day 210
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 Normal Haematological Levels
时间窗: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Below Normal
时间窗: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Above Normal
时间窗: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
次要结局
- Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule(At Day 0, 30, 60 and 210)
- Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes(From Day 60 to Day 210)
- Cell Count of CD4+ T Cells(At Day 0, 30, 60 and 210)
- Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines(At Day 0, 30, 60 and 210)
- Anti-M72 Specific Antibody Concentrations(At Day 0, 30, 60 and 210)