Safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in adults with tuberculosis: A phase II randomised study
| Autor: | Philippe Moris, Shih-Lung Cheng, Manfred Danilovits, Wei-Juin Su, Paul Gillard, Marcela Castro, Anne Bollaerts, Opokua Ofori-Anyinam, Pan-Chyr Yang, Lea Pehme, Erik Jongert, Marie-Ange Demoitié |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
CD4-Positive T-Lymphocytes Male 0301 basic medicine Microbiology (medical) medicine.medical_specialty Tuberculosis Adolescent MedDRA Immunology Pain Microbiology Mycobacterium tuberculosis Young Adult 03 medical and health sciences T-cell Internal medicine Humans Medicine Single-Blind Method Tuberculosis Vaccines Adverse effect Immunity Cellular Reactogenicity biology business.industry Middle Aged M72/AS01E vaccine medicine.disease biology.organism_classification Antibodies Bacterial Immunogenicity Vaccination 030104 developmental biology Infectious Diseases Erythema Cohort Female Safety business Tuberculosis vaccines |
| Zdroj: | Tuberculosis. 100:118-127 |
| ISSN: | 1472-9792 |
| DOI: | 10.1016/j.tube.2016.07.005 |
| Popis: | Summary Previous studies have shown that the M72/AS01 E candidate tuberculosis vaccine is immunogenic with a clinically acceptable safety profile in healthy and Mycobacterium tuberculosis -infected adults. This phase II, observer-blind, randomised study compared the safety, reactogenicity, and immunogenicity of M72/AS01 E in 3 cohorts: tuberculosis-naive adults (n = 80), adults previously treated for tuberculosis (n = 49), and adults who have completed the intensive phase of tuberculosis treatment (n = 13). In each cohort, 18–59-year-old adults were randomised (1:1) to receive two doses of M72/AS01 E (n = 71) or placebo (n = 71) and followed-up until six months post-dose 2. Safety and reactogenicity were assessed as primary objective. Recruitment in the study ended prematurely because of a high incidence of large injection site redness/swelling reactions in M72/AS01 E -vaccinated adults undergoing tuberculosis treatment. No additional clinically relevant adverse events were observed, except one possibly vaccine-related serious adverse event (hypersensitivity in a tuberculosis-treated-M72/AS01 E participant). Robust and persistent M72-specific humoral and polyfunctional CD4 + T-cell-mediated immune responses were observed post-M72/AS01 E vaccination in each cohort. In conclusion, the M72/AS01 E vaccine was immunogenic in adults previously or currently treated for tuberculosis, but further analyses are needed to explain the high local reactogenicity in adults undergoing tuberculosis treatment. ClinicalTrials.gov: NCT01424501 |
| Databáze: | OpenAIRE |
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