Safety and immunogenicity of the novel H4:IC31 tuberculosis vaccine candidate in BCG-vaccinated adults: Two phase I dose escalation trials - Norrby, Maria; Vesikari, Timo; Lindqvist, Lars; Maeurer, Markus; Ahmed, Raija; Mahdavifar, Shahnaz; Bennett, Sean; McClain, J. Bruce; Shepherd, Barbara M.; Li, Daner; Hokey, David A.; Kromann, Ingrid; et al. (Vaccine, 2017)
Keywords: Acyltransferases - administration & dosage; Acyltransferases - adverse effects; Acyltransferases - immunology; adjuvants; Adult; adults; Allergy and Immunology; Antigens; Antigens, Bacterial - administration & dosage; Antigens, Bacterial - adverse effects; Antigens, Bacterial - immunology; Bacterial Proteins - administration & dosage; Bacterial Proteins - adverse effects; Bacterial Proteins - immunology; CD4-positive T-lymphocytes; CD4-Positive T-Lymphocytes - immunology; cell proliferation; Clinical trial; Clinical trials; cytokines; Double-Blind Method; Drug Combinations; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Family medical history; fever; Finland; Health care; Healthy Volunteers; Human; Humans; immune response; Immunity; Immunization; Immunogenicity; Injection; injection site; interferon-gamma; Mycobacterium; Mycobacterium tuberculosis; Neutrophils; Oligodeoxyribonucleotides - administration & dosage; Oligodeoxyribonucleotides - adverse effects; Oligopeptides - administration & dosage; Oligopeptides - adverse effects; pain; placebos; Placebos - administration & dosage; Proteins; Safety; screening; Studies; Sweden; Treatment Outcome; tuberculin; Tuberculosis; Tuberculosis - prevention & control; Tuberculosis Vaccines - administration & dosage; Tuberculosis Vaccines - adverse effects; Tuberculosis Vaccines - immunology; Urine; vaccination; Vaccine; Vaccines; Sweden; Finland; ANE, Sweden; ANE, Finland; Human; AE; BCG; MHC; Vaccine; INR; Immunity; TB; FASCIA; Tuberculosis; TST; ICS; Clinical trial; Mtb; MDR; Safety; bacillus Calmette-Guérin; major histocompatibility complex; Flow-cytometric Assay for Specific Cell-mediated Immune-response in Activated whole blood; international normalized ratio; multidrug-resistant; tuberculosis; adverse events; tuberculin skin test; intracellular cytokine staining; Mycobacterium tuberculosis