Tuberculosis Clinical Trial
Official title:
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.
NCT number | NCT00707967 |
Other study ID # | 111517 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 30, 2008 |
Est. completion date | May 27, 2009 |
Verified date | November 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | May 27, 2009 |
Est. primary completion date | May 27, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | GSK Investigational Site | Lausanne |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Solicited Local Symptoms | 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. | During the 7-day period (Days 0-6) post vaccination following each dose | |
Primary | Number of Subjects With Solicited General Symptoms | 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. | During the 7-day period (Days 0-6) post vaccination following each dose | |
Primary | Number of Subjects With Unsolicited Adverse Events (AEs) | 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. | During the 30-day period (Days 0-29) post vaccination | |
Primary | Number of Subjects With Serious Adverse Events (SAEs) | 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 | During the entire study period, from Day 0 up to Day 210 | |
Primary | Number of Subjects With Normal Biochemical and Haematological Levels | 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. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Normal Haematological Levels | 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. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Normal Haematological Levels | Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Biochemical and Haematological Levels Below Normal | 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. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Haematological Levels Below Normal | 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. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Haematological Levels Below Normal | Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Biochemical and Haematological Levels Above Normal | 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. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Haematological Levels Above Normal | 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. | At Day 0, 7, 30, 37 and 60 | |
Primary | Number of Subjects With Haematological Levels Above Normal | Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above. | At Day 0, 7, 30, 37 and 60 | |
Secondary | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines | Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-?] and/or tumour necrosis factor-alpha [TNF-a] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At Day 0, 30, 60 and 210 | |
Secondary | Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule | Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-?] or tumour necrosis factor-alpha [TNF-a]; IL-2 and CD40-L, or IFN-?, or TNF-a; IFN-? and CD40-L, or IL-2, or TNF-a; TNF-a and CD40-L, or IL-2, or IFN-?. For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines. |
At Day 0, 30, 60 and 210 | |
Secondary | Cell Count of CD4+ T Cells | CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study. | At Day 0, 30, 60 and 210 | |
Secondary | Anti-M72 Specific Antibody Concentrations | Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs). | At Day 0, 30, 60 and 210 | |
Secondary | Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes | Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment. | From Day 60 to Day 210 |
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