Phase 2
Completed N=110
Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults
Source: ClinicalTrials.gov NCT00397943 ↗Enrolled (actual)
110
Serious AEs
3.6%
Results posted
Aug 2018
Primary outcomePrimary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms — 38; 40; 9; 1 Participants
Summary
This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
38; 40; 9; 1; 10; 7 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
27; 21; 6; 2; 3; 0 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
37; 33; 10; 7; 7; 12 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects With SAEs |
0; 0 | — |
| PRIMARY Number of Subjects With SAEs |
0; 0 | — |
| PRIMARY Number of Subjects With SAEs |
0; 0 | — |
| PRIMARY Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels |
39; 39; 10; 10; 10; 0 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels |
38; 40; 10; 10; 10; 2 | — |
| PRIMARY Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels |
39; 39; 10; 10; 10; 0 | — |
| PRIMARY Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels |
39; 39; 10; 10; 10; 0 | — |
| PRIMARY Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels |
39; 39; 10; 10; 10; 0 | — |
| PRIMARY Levels of C-reactive Protein |
0.30; 0.20; 0.20; 0.10; 0.25 | — |
| PRIMARY Levels of C-reactive Protein |
0.30; 0.20; 0.20; 0.10; 0.25 | — |
| PRIMARY Levels of C-reactive Protein |
0.30; 0.20; 0.20; 0.10; 0.25 | — |
| PRIMARY Levels of C-reactive Protein |
0.30; 0.20; 0.20; 0.10; 0.25 | — |
| PRIMARY Levels of C-reactive Protein |
0.30; 0.20; 0.20; 0.10; 0.25 | — |
| PRIMARY Levels of C-reactive Protein |
0.30; 0.20; 0.20; 0.10; 0.25 | — |
| PRIMARY Levels of Immunoglobulin E |
35.00; 60.35; 49.15; 40.85; 44.20 | — |
| PRIMARY Levels of Immunoglobulin E |
35.00; 60.35; 49.15; 40.85; 44.20 | — |
| PRIMARY Levels of Immunoglobulin E |
35.00; 60.35; 49.15; 40.85; 44.20 | — |
| PRIMARY Levels of Immunoglobulin E |
35.00; 60.35; 49.15; 40.85; 44.20 | — |
| PRIMARY Levels of Immunoglobulin E |
35.00; 60.35; 49.15; 40.85; 44.20 | — |
| PRIMARY Levels of Immunoglobulin E |
35.00; 60.35; 49.15; 40.85; 44.20 | — |
| SECONDARY Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F |
1.4; 1.4; 1.4; 1.4; 1.4; 24.7 | — |
| SECONDARY Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 |
38.9; 21.6; 29.2; 19.3 | — |
| SECONDARY Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines |
90.5; 65.5; 58.0; 134.5; 45.0; 955.5 | — |
| SECONDARY Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines |
1506.0; 826.0; 1313.0; 507.0 | — |
| SECONDARY Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule |
1467.0; 800.0; 1106.5; 493.5; 574.0; 307.0 | — |
| SECONDARY Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule |
1467.0; 800.0; 1106.5; 493.5; 574.0; 307.0 | — |
| SECONDARY Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers |
31; 36; 24; 23 | — |
| SECONDARY Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers |
31; 36; 24; 23 | — |
| SECONDARY Concentrations of IFN-γ Produced in Serum Samples |
0.6; 0.6; 0.6; 1.0; 1.0; 4.5 | — |
Eligibility Criteria
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.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subjects must have PPD negative skin reactivity (0 mm induration 48 to 72 hours after PPD skin test administration).
- Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
- Seronegative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
Exclusion Criteria
- History of previous exposure to experimental products containing components of the experimental vaccine.
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period. Vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen are allowed.
- History of documented exposure to Mycobacterium tuberculosis.
- History of prior vaccination with experimental Mycobacterium tuberculosis vaccines.
- Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
- Participation in another experimental protocol during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
- History of hypersensitivity to vaccines or vaccine components
- History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease.
- History of any neurological disorders or seizures.
- History of chronic alcohol consumption and/or drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects.
- Pregnant female, lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions.
Data sourced from ClinicalTrials.gov (NCT00397943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.