Cargando…

Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers...

Descripción completa

Detalles Bibliográficos
Autores principales: Kang, Kyuri, Han, Seunghoon, Hong, Taegon, Jeon, Sangil, Paek, Jeongki, Kang, Jin Han, Yim, Dong-Seok
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Yonsei University College of Medicine 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5011266/
https://www.ncbi.nlm.nih.gov/pubmed/27593862
http://dx.doi.org/10.3349/ymj.2016.57.6.1354
_version_ 1782451795855933440
author Kang, Kyuri
Han, Seunghoon
Hong, Taegon
Jeon, Sangil
Paek, Jeongki
Kang, Jin Han
Yim, Dong-Seok
author_facet Kang, Kyuri
Han, Seunghoon
Hong, Taegon
Jeon, Sangil
Paek, Jeongki
Kang, Jin Han
Yim, Dong-Seok
author_sort Kang, Kyuri
collection PubMed
description PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. RESULTS: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. CONCLUSION: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.
format Online
Article
Text
id pubmed-5011266
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher Yonsei University College of Medicine
record_format MEDLINE/PubMed
spelling pubmed-50112662016-11-01 Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial Kang, Kyuri Han, Seunghoon Hong, Taegon Jeon, Sangil Paek, Jeongki Kang, Jin Han Yim, Dong-Seok Yonsei Med J Original Article PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. RESULTS: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. CONCLUSION: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial. Yonsei University College of Medicine 2016-11-01 2016-08-30 /pmc/articles/PMC5011266/ /pubmed/27593862 http://dx.doi.org/10.3349/ymj.2016.57.6.1354 Text en © Copyright: Yonsei University College of Medicine 2016 http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kang, Kyuri
Han, Seunghoon
Hong, Taegon
Jeon, Sangil
Paek, Jeongki
Kang, Jin Han
Yim, Dong-Seok
Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
title Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
title_full Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
title_fullStr Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
title_full_unstemmed Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
title_short Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
title_sort immunogenicity and safety of trivalent split influenza vaccine in healthy korean adults with low pre-existing antibody levels: an open phase i trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5011266/
https://www.ncbi.nlm.nih.gov/pubmed/27593862
http://dx.doi.org/10.3349/ymj.2016.57.6.1354
work_keys_str_mv AT kangkyuri immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial
AT hanseunghoon immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial
AT hongtaegon immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial
AT jeonsangil immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial
AT paekjeongki immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial
AT kangjinhan immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial
AT yimdongseok immunogenicityandsafetyoftrivalentsplitinfluenzavaccineinhealthykoreanadultswithlowpreexistingantibodylevelsanopenphaseitrial