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Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting

Abstract Background Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB ende... Full description

Journal Title: Vaccine 2015, Vol.33 (32), p.4025-4034
Main Author: Penn-Nicholson, Adam
Other Authors: Geldenhuys, Hennie , Burny, Wivine , van der Most, Robbert , Day, Cheryl L , Jongert, Erik , Moris, Philippe , Hatherill, Mark , Ofori-Anyinam, Opokua , Hanekom, Willem , Bollaerts, Anne , Demoitie, Marie-Ange , Kany Luabeya, Angelique Kany , De Ruymaeker, Evi , Tameris, Michele , Lapierre, Didier , Scriba, Thomas J
Format: Electronic Article Electronic Article
Language: English
Subjects:
M72
Quelle: Alma/SFX Local Collection
Publisher: Netherlands: Elsevier Ltd
ID: ISSN: 0264-410X
Link: https://www.ncbi.nlm.nih.gov/pubmed/26072017
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5845829
title: Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting
format: Article
creator:
  • Penn-Nicholson, Adam
  • Geldenhuys, Hennie
  • Burny, Wivine
  • van der Most, Robbert
  • Day, Cheryl L
  • Jongert, Erik
  • Moris, Philippe
  • Hatherill, Mark
  • Ofori-Anyinam, Opokua
  • Hanekom, Willem
  • Bollaerts, Anne
  • Demoitie, Marie-Ange
  • Kany Luabeya, Angelique Kany
  • De Ruymaeker, Evi
  • Tameris, Michele
  • Lapierre, Didier
  • Scriba, Thomas J
subjects:
  • Adolescent
  • Allergy and Immunology
  • Antigens, Bacterial - immunology
  • Article
  • AS01E
  • Cytokine
  • Cytokines - biosynthesis
  • Double-Blind Method
  • Drug Combinations
  • Drug-Related Side Effects and Adverse Reactions - epidemiology
  • Drug-Related Side Effects and Adverse Reactions - pathology
  • Endemic Diseases
  • Environmental
  • Female
  • Flow Cytometry
  • Human immunodeficiency virus
  • Humans
  • Immunology
  • Infectious Diseases
  • Injections, Intramuscular
  • Killer Cells, Natural - immunology
  • Lipid A - administration & dosage
  • Lipid A - adverse effects
  • Lipid A - analogs & derivatives
  • M72
  • M72/AS01E
  • Male
  • Microbiology(all)
  • Molecular Medicine
  • Mycobacterium tuberculosis
  • Mycobacterium tuberculosis - immunology
  • NK cell
  • Occupational Health
  • Placebos - administration & dosage
  • Public Health
  • Saponins - administration & dosage
  • Saponins - adverse effects
  • Staining and Labeling
  • T cell
  • T-Lymphocytes - immunology
  • Treatment Outcome
  • Tuberculosis
  • Tuberculosis - epidemiology
  • Tuberculosis - prevention & control
  • Tuberculosis Vaccines - administration & dosage
  • Tuberculosis Vaccines - adverse effects
  • Tuberculosis Vaccines - immunology
  • Vaccine
  • Vaccines, Subunit - administration & dosage
  • Vaccines, Subunit - adverse effects
  • Vaccines, Subunit - immunology
  • veterinary(all)
ispartof: Vaccine, 2015, Vol.33 (32), p.4025-4034
description: Abstract Background Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB endemic region, regardless of Mycobacterium tuberculosis ( M.tb ) infection status. Methods In a phase II, double-blind randomized, controlled study ( NCT00950612 ), two doses of M72/AS01E or placebo were administered intramuscularly, one month apart. Participants were followed-up post-vaccination, for 6 months. M72-specific immunogenicity was evaluated by intracellular cytokine staining analysis of T cells and NK cells by flow cytometry. Results No serious adverse events were recorded. M72/AS01E induced robust T cell and antibody responses, including antigen-dependent NK cell IFN-γ production. CD4 and CD8 T cell responses were sustained at 6 months post vaccination. Irrespective of M.tb infection status, vaccination induced a high frequency of M72-specific CD4 T cells expressing multiple combinations of Th1 cytokines, and low level IL-17. We observed rapid boosting of immune responses in M.tb -infected participants, suggesting natural infection acts as a prime to vaccination. Conclusions The clinically acceptable safety and immunogenicity profile of M72/AS01E in adolescents living in an area with high TB burden support the move to efficacy trials.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleSafety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting
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creatorPenn-Nicholson, Adam ; Geldenhuys, Hennie ; Burny, Wivine ; van der Most, Robbert ; Day, Cheryl L ; Jongert, Erik ; Moris, Philippe ; Hatherill, Mark ; Ofori-Anyinam, Opokua ; Hanekom, Willem ; Bollaerts, Anne ; Demoitie, Marie-Ange ; Kany Luabeya, Angelique Kany ; De Ruymaeker, Evi ; Tameris, Michele ; Lapierre, Didier ; Scriba, Thomas J
creatorcontribPenn-Nicholson, Adam ; Geldenhuys, Hennie ; Burny, Wivine ; van der Most, Robbert ; Day, Cheryl L ; Jongert, Erik ; Moris, Philippe ; Hatherill, Mark ; Ofori-Anyinam, Opokua ; Hanekom, Willem ; Bollaerts, Anne ; Demoitie, Marie-Ange ; Kany Luabeya, Angelique Kany ; De Ruymaeker, Evi ; Tameris, Michele ; Lapierre, Didier ; Scriba, Thomas J ; the Vaccine Study Team ; Vaccine Study Team
descriptionAbstract Background Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB endemic region, regardless of Mycobacterium tuberculosis ( M.tb ) infection status. Methods In a phase II, double-blind randomized, controlled study ( NCT00950612 ), two doses of M72/AS01E or placebo were administered intramuscularly, one month apart. Participants were followed-up post-vaccination, for 6 months. M72-specific immunogenicity was evaluated by intracellular cytokine staining analysis of T cells and NK cells by flow cytometry. Results No serious adverse events were recorded. M72/AS01E induced robust T cell and antibody responses, including antigen-dependent NK cell IFN-γ production. CD4 and CD8 T cell responses were sustained at 6 months post vaccination. Irrespective of M.tb infection status, vaccination induced a high frequency of M72-specific CD4 T cells expressing multiple combinations of Th1 cytokines, and low level IL-17. We observed rapid boosting of immune responses in M.tb -infected participants, suggesting natural infection acts as a prime to vaccination. Conclusions The clinically acceptable safety and immunogenicity profile of M72/AS01E in adolescents living in an area with high TB burden support the move to efficacy trials.
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1Geldenhuys, Hennie
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9Hanekom, Willem
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11Demoitie, Marie-Ange
12Kany Luabeya, Angelique Kany
13De Ruymaeker, Evi
14Tameris, Michele
15Lapierre, Didier
16Scriba, Thomas J
17the Vaccine Study Team
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0Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting
1Vaccine
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descriptionAbstract Background Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB endemic region, regardless of Mycobacterium tuberculosis ( M.tb ) infection status. Methods In a phase II, double-blind randomized, controlled study ( NCT00950612 ), two doses of M72/AS01E or placebo were administered intramuscularly, one month apart. Participants were followed-up post-vaccination, for 6 months. M72-specific immunogenicity was evaluated by intracellular cytokine staining analysis of T cells and NK cells by flow cytometry. Results No serious adverse events were recorded. M72/AS01E induced robust T cell and antibody responses, including antigen-dependent NK cell IFN-γ production. CD4 and CD8 T cell responses were sustained at 6 months post vaccination. Irrespective of M.tb infection status, vaccination induced a high frequency of M72-specific CD4 T cells expressing multiple combinations of Th1 cytokines, and low level IL-17. We observed rapid boosting of immune responses in M.tb -infected participants, suggesting natural infection acts as a prime to vaccination. Conclusions The clinically acceptable safety and immunogenicity profile of M72/AS01E in adolescents living in an area with high TB burden support the move to efficacy trials.
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0Adolescent
1Allergy and Immunology
2Antigens, Bacterial - immunology
3Article
4AS01E
5Cytokine
6Cytokines - biosynthesis
7Double-Blind Method
8Drug Combinations
9Drug-Related Side Effects and Adverse Reactions - epidemiology
10Drug-Related Side Effects and Adverse Reactions - pathology
11Endemic Diseases
12Environmental
13Female
14Flow Cytometry
15Human immunodeficiency virus
16Humans
17Immunology
18Infectious Diseases
19Injections, Intramuscular
20Killer Cells, Natural - immunology
21Lipid A - administration & dosage
22Lipid A - adverse effects
23Lipid A - analogs & derivatives
24M72
25M72/AS01E
26Male
27Microbiology(all)
28Molecular Medicine
29Mycobacterium tuberculosis
30Mycobacterium tuberculosis - immunology
31NK cell
32Occupational Health
33Placebos - administration & dosage
34Public Health
35Saponins - administration & dosage
36Saponins - adverse effects
37Staining and Labeling
38T cell
39T-Lymphocytes - immunology
40Treatment Outcome
41Tuberculosis
42Tuberculosis - epidemiology
43Tuberculosis - prevention & control
44Tuberculosis Vaccines - administration & dosage
45Tuberculosis Vaccines - adverse effects
46Tuberculosis Vaccines - immunology
47Vaccine
48Vaccines, Subunit - administration & dosage
49Vaccines, Subunit - adverse effects
50Vaccines, Subunit - immunology
51veterinary(all)
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1Geldenhuys, Hennie
2Burny, Wivine
3van der Most, Robbert
4Day, Cheryl L
5Jongert, Erik
6Moris, Philippe
7Hatherill, Mark
8Ofori-Anyinam, Opokua
9Hanekom, Willem
10Bollaerts, Anne
11Demoitie, Marie-Ange
12Kany Luabeya, Angelique Kany
13De Ruymaeker, Evi
14Tameris, Michele
15Lapierre, Didier
16Scriba, Thomas J
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titleSafety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting
authorPenn-Nicholson, Adam ; Geldenhuys, Hennie ; Burny, Wivine ; van der Most, Robbert ; Day, Cheryl L ; Jongert, Erik ; Moris, Philippe ; Hatherill, Mark ; Ofori-Anyinam, Opokua ; Hanekom, Willem ; Bollaerts, Anne ; Demoitie, Marie-Ange ; Kany Luabeya, Angelique Kany ; De Ruymaeker, Evi ; Tameris, Michele ; Lapierre, Didier ; Scriba, Thomas J
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0Adolescent
1Allergy and Immunology
2Antigens, Bacterial - immunology
3Article
4AS01E
5Cytokine
6Cytokines - biosynthesis
7Double-Blind Method
8Drug Combinations
9Drug-Related Side Effects and Adverse Reactions - epidemiology
10Drug-Related Side Effects and Adverse Reactions - pathology
11Endemic Diseases
12Environmental
13Female
14Flow Cytometry
15Human immunodeficiency virus
16Humans
17Immunology
18Infectious Diseases
19Injections, Intramuscular
20Killer Cells, Natural - immunology
21Lipid A - administration & dosage
22Lipid A - adverse effects
23Lipid A - analogs & derivatives
24M72
25M72/AS01E
26Male
27Microbiology(all)
28Molecular Medicine
29Mycobacterium tuberculosis
30Mycobacterium tuberculosis - immunology
31NK cell
32Occupational Health
33Placebos - administration & dosage
34Public Health
35Saponins - administration & dosage
36Saponins - adverse effects
37Staining and Labeling
38T cell
39T-Lymphocytes - immunology
40Treatment Outcome
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42Tuberculosis - epidemiology
43Tuberculosis - prevention & control
44Tuberculosis Vaccines - administration & dosage
45Tuberculosis Vaccines - adverse effects
46Tuberculosis Vaccines - immunology
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49Vaccines, Subunit - adverse effects
50Vaccines, Subunit - immunology
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5Jongert, Erik
6Moris, Philippe
7Hatherill, Mark
8Ofori-Anyinam, Opokua
9Hanekom, Willem
10Bollaerts, Anne
11Demoitie, Marie-Ange
12Kany Luabeya, Angelique Kany
13De Ruymaeker, Evi
14Tameris, Michele
15Lapierre, Didier
16Scriba, Thomas J
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0Penn-Nicholson, Adam
1Geldenhuys, Hennie
2Burny, Wivine
3van der Most, Robbert
4Day, Cheryl L
5Jongert, Erik
6Moris, Philippe
7Hatherill, Mark
8Ofori-Anyinam, Opokua
9Hanekom, Willem
10Bollaerts, Anne
11Demoitie, Marie-Ange
12Kany Luabeya, Angelique Kany
13De Ruymaeker, Evi
14Tameris, Michele
15Lapierre, Didier
16Scriba, Thomas J
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atitleSafety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting
jtitleVaccine
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date2015
risdate2015
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epage4034
pages4025-4034
issn0264-410X
eissn1873-2518
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0These authors contributed equally to this work.
1Equal senior authorship.
abstractAbstract Background Vaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB endemic region, regardless of Mycobacterium tuberculosis ( M.tb ) infection status. Methods In a phase II, double-blind randomized, controlled study ( NCT00950612 ), two doses of M72/AS01E or placebo were administered intramuscularly, one month apart. Participants were followed-up post-vaccination, for 6 months. M72-specific immunogenicity was evaluated by intracellular cytokine staining analysis of T cells and NK cells by flow cytometry. Results No serious adverse events were recorded. M72/AS01E induced robust T cell and antibody responses, including antigen-dependent NK cell IFN-γ production. CD4 and CD8 T cell responses were sustained at 6 months post vaccination. Irrespective of M.tb infection status, vaccination induced a high frequency of M72-specific CD4 T cells expressing multiple combinations of Th1 cytokines, and low level IL-17. We observed rapid boosting of immune responses in M.tb -infected participants, suggesting natural infection acts as a prime to vaccination. Conclusions The clinically acceptable safety and immunogenicity profile of M72/AS01E in adolescents living in an area with high TB burden support the move to efficacy trials.
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pubElsevier Ltd
pmid26072017
doi10.1016/j.vaccine.2015.05.088
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