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The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses

Abstract Background Efforts to reduce risk of tuberculosis disease in children include development of effective vaccines. Our aim was to test safety and immunogenicity of the new adenovirus 35-vectored tuberculosis vaccine candidate AERAS-402 in infants, administered as a boost following a prime wit... Full description

Journal Title: Vaccine 2014, Vol.32 (45), p.5908-5917
Main Author: Kagina, Benjamin M.N
Other Authors: Tameris, Michele D , Geldenhuys, Hennie , Hatherill, Mark , Abel, Brian , Hussey, Gregory D , Scriba, Thomas J , Mahomed, Hassan , Sadoff, Jerald C , Hanekom, Willem A
Format: Electronic Article Electronic Article
Language: English
Subjects:
Age
BCG
Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0264-410X
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title: The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses
format: Article
creator:
  • Kagina, Benjamin M.N
  • Tameris, Michele D
  • Geldenhuys, Hennie
  • Hatherill, Mark
  • Abel, Brian
  • Hussey, Gregory D
  • Scriba, Thomas J
  • Mahomed, Hassan
  • Sadoff, Jerald C
  • Hanekom, Willem A
subjects:
  • AERAS-402
  • Age
  • Allergy and Immunology
  • Antitubercular agents
  • Applied microbiology
  • BCG
  • BCG Vaccine - administration & dosage
  • Biological and medical sciences
  • CD4-Positive T-Lymphocytes - immunology
  • CD8-Positive T-Lymphocytes - immunology
  • Child development
  • Clinical trials
  • Cloning
  • Cytokines
  • Dose-Response Relationship, Immunologic
  • Double-Blind Method
  • Female
  • Fundamental and applied biological sciences. Psychology
  • Humans
  • Immunization, Secondary
  • Infant
  • Infants
  • Interferon-gamma - immunology
  • Interleukin-2 - immunology
  • Lymphocytes
  • Male
  • Microbiology
  • Pandemics
  • Peptides
  • South Africa
  • Tuberculosis
  • Tuberculosis - prevention & control
  • Tuberculosis vaccines
  • Tuberculosis Vaccines - adverse effects
  • Tuberculosis Vaccines - therapeutic use
  • Tumor Necrosis Factor-alpha - immunology
  • Vaccination
  • Vaccine-induced T cell immunity
  • Vaccines
  • Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
ispartof: Vaccine, 2014, Vol.32 (45), p.5908-5917
description: Abstract Background Efforts to reduce risk of tuberculosis disease in children include development of effective vaccines. Our aim was to test safety and immunogenicity of the new adenovirus 35-vectored tuberculosis vaccine candidate AERAS-402 in infants, administered as a boost following a prime with the Bacille Calmette-Guerin vaccine. Methods In a phase 1 randomised, double-blind, placebo-controlled, dose-escalation trial, BCG-vaccinated infants aged 6–9 months were sequentially assigned to four study groups, then randomized to receive an increasing dose-strength of AERAS-402, or placebo. The highest dose group received a second dose of vaccine or placebo 56 days after the first. The primary study outcome was safety. Whole blood intracellular cytokine staining assessed immunogenicity. Results Forty-two infants received AERAS-402 and 15 infants received placebo. During follow-up of 182 days, an acceptable safety profile was shown with no serious adverse events or discontinuations related to the vaccine. AERAS-402 induced a specific T cell response. A single dose of AERAS-402 induced CD4T cells predominantly expressing single IFN-γ whereas two doses induced CD4T cells predominantly expressing IFN-γ, TNF-α and IL-2 together. CD8T cells were induced and were more likely to be present after 2 doses of AERAS-402. Conclusions AERAS-402 was safe and immunogenic in healthy infants previously vaccinated with BCG at birth. Administration of the highest dose twice may be the most optimal vaccination strategy, based on the induced immunity. Multiple differences in T cell responses when infants are compared with adults vaccinated with AERAS-402, in the same setting and using the same whole blood intracellular cytokine assay, suggest specific strategies may be important for vaccination for each population.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleThe novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses
sourceAlma/SFX Local Collection
creatorKagina, Benjamin M.N ; Tameris, Michele D ; Geldenhuys, Hennie ; Hatherill, Mark ; Abel, Brian ; Hussey, Gregory D ; Scriba, Thomas J ; Mahomed, Hassan ; Sadoff, Jerald C ; Hanekom, Willem A
creatorcontribKagina, Benjamin M.N ; Tameris, Michele D ; Geldenhuys, Hennie ; Hatherill, Mark ; Abel, Brian ; Hussey, Gregory D ; Scriba, Thomas J ; Mahomed, Hassan ; Sadoff, Jerald C ; Hanekom, Willem A ; 018-402 Clinical Lab study team
descriptionAbstract Background Efforts to reduce risk of tuberculosis disease in children include development of effective vaccines. Our aim was to test safety and immunogenicity of the new adenovirus 35-vectored tuberculosis vaccine candidate AERAS-402 in infants, administered as a boost following a prime with the Bacille Calmette-Guerin vaccine. Methods In a phase 1 randomised, double-blind, placebo-controlled, dose-escalation trial, BCG-vaccinated infants aged 6–9 months were sequentially assigned to four study groups, then randomized to receive an increasing dose-strength of AERAS-402, or placebo. The highest dose group received a second dose of vaccine or placebo 56 days after the first. The primary study outcome was safety. Whole blood intracellular cytokine staining assessed immunogenicity. Results Forty-two infants received AERAS-402 and 15 infants received placebo. During follow-up of 182 days, an acceptable safety profile was shown with no serious adverse events or discontinuations related to the vaccine. AERAS-402 induced a specific T cell response. A single dose of AERAS-402 induced CD4T cells predominantly expressing single IFN-γ whereas two doses induced CD4T cells predominantly expressing IFN-γ, TNF-α and IL-2 together. CD8T cells were induced and were more likely to be present after 2 doses of AERAS-402. Conclusions AERAS-402 was safe and immunogenic in healthy infants previously vaccinated with BCG at birth. Administration of the highest dose twice may be the most optimal vaccination strategy, based on the induced immunity. Multiple differences in T cell responses when infants are compared with adults vaccinated with AERAS-402, in the same setting and using the same whole blood intracellular cytokine assay, suggest specific strategies may be important for vaccination for each population.
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publisherKidlington: Elsevier Ltd
subjectAERAS-402 ; Age ; Allergy and Immunology ; Antitubercular agents ; Applied microbiology ; BCG ; BCG Vaccine - administration & dosage ; Biological and medical sciences ; CD4-Positive T-Lymphocytes - immunology ; CD8-Positive T-Lymphocytes - immunology ; Child development ; Clinical trials ; Cloning ; Cytokines ; Dose-Response Relationship, Immunologic ; Double-Blind Method ; Female ; Fundamental and applied biological sciences. Psychology ; Humans ; Immunization, Secondary ; Infant ; Infants ; Interferon-gamma - immunology ; Interleukin-2 - immunology ; Lymphocytes ; Male ; Microbiology ; Pandemics ; Peptides ; South Africa ; Tuberculosis ; Tuberculosis - prevention & control ; Tuberculosis vaccines ; Tuberculosis Vaccines - adverse effects ; Tuberculosis Vaccines - therapeutic use ; Tumor Necrosis Factor-alpha - immunology ; Vaccination ; Vaccine-induced T cell immunity ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
ispartofVaccine, 2014, Vol.32 (45), p.5908-5917
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2Geldenhuys, Hennie
3Hatherill, Mark
4Abel, Brian
5Hussey, Gregory D
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7Mahomed, Hassan
8Sadoff, Jerald C
9Hanekom, Willem A
10018-402 Clinical Lab study team
title
0The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses
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descriptionAbstract Background Efforts to reduce risk of tuberculosis disease in children include development of effective vaccines. Our aim was to test safety and immunogenicity of the new adenovirus 35-vectored tuberculosis vaccine candidate AERAS-402 in infants, administered as a boost following a prime with the Bacille Calmette-Guerin vaccine. Methods In a phase 1 randomised, double-blind, placebo-controlled, dose-escalation trial, BCG-vaccinated infants aged 6–9 months were sequentially assigned to four study groups, then randomized to receive an increasing dose-strength of AERAS-402, or placebo. The highest dose group received a second dose of vaccine or placebo 56 days after the first. The primary study outcome was safety. Whole blood intracellular cytokine staining assessed immunogenicity. Results Forty-two infants received AERAS-402 and 15 infants received placebo. During follow-up of 182 days, an acceptable safety profile was shown with no serious adverse events or discontinuations related to the vaccine. AERAS-402 induced a specific T cell response. A single dose of AERAS-402 induced CD4T cells predominantly expressing single IFN-γ whereas two doses induced CD4T cells predominantly expressing IFN-γ, TNF-α and IL-2 together. CD8T cells were induced and were more likely to be present after 2 doses of AERAS-402. Conclusions AERAS-402 was safe and immunogenic in healthy infants previously vaccinated with BCG at birth. Administration of the highest dose twice may be the most optimal vaccination strategy, based on the induced immunity. Multiple differences in T cell responses when infants are compared with adults vaccinated with AERAS-402, in the same setting and using the same whole blood intracellular cytokine assay, suggest specific strategies may be important for vaccination for each population.
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4Applied microbiology
5BCG
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20Infant
21Infants
22Interferon-gamma - immunology
23Interleukin-2 - immunology
24Lymphocytes
25Male
26Microbiology
27Pandemics
28Peptides
29South Africa
30Tuberculosis
31Tuberculosis - prevention & control
32Tuberculosis vaccines
33Tuberculosis Vaccines - adverse effects
34Tuberculosis Vaccines - therapeutic use
35Tumor Necrosis Factor-alpha - immunology
36Vaccination
37Vaccine-induced T cell immunity
38Vaccines
39Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
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titleThe novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses
authorKagina, Benjamin M.N ; Tameris, Michele D ; Geldenhuys, Hennie ; Hatherill, Mark ; Abel, Brian ; Hussey, Gregory D ; Scriba, Thomas J ; Mahomed, Hassan ; Sadoff, Jerald C ; Hanekom, Willem A
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8CD4-Positive T-Lymphocytes - immunology
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35Tumor Necrosis Factor-alpha - immunology
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7Mahomed, Hassan
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abstractAbstract Background Efforts to reduce risk of tuberculosis disease in children include development of effective vaccines. Our aim was to test safety and immunogenicity of the new adenovirus 35-vectored tuberculosis vaccine candidate AERAS-402 in infants, administered as a boost following a prime with the Bacille Calmette-Guerin vaccine. Methods In a phase 1 randomised, double-blind, placebo-controlled, dose-escalation trial, BCG-vaccinated infants aged 6–9 months were sequentially assigned to four study groups, then randomized to receive an increasing dose-strength of AERAS-402, or placebo. The highest dose group received a second dose of vaccine or placebo 56 days after the first. The primary study outcome was safety. Whole blood intracellular cytokine staining assessed immunogenicity. Results Forty-two infants received AERAS-402 and 15 infants received placebo. During follow-up of 182 days, an acceptable safety profile was shown with no serious adverse events or discontinuations related to the vaccine. AERAS-402 induced a specific T cell response. A single dose of AERAS-402 induced CD4T cells predominantly expressing single IFN-γ whereas two doses induced CD4T cells predominantly expressing IFN-γ, TNF-α and IL-2 together. CD8T cells were induced and were more likely to be present after 2 doses of AERAS-402. Conclusions AERAS-402 was safe and immunogenic in healthy infants previously vaccinated with BCG at birth. Administration of the highest dose twice may be the most optimal vaccination strategy, based on the induced immunity. Multiple differences in T cell responses when infants are compared with adults vaccinated with AERAS-402, in the same setting and using the same whole blood intracellular cytokine assay, suggest specific strategies may be important for vaccination for each population.
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pubElsevier Ltd
pmid25218194
doi10.1016/j.vaccine.2014.09.001