Giuseppe
Emeritus
[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]
Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in a Pediatric Population
Maikel V. W. van der Velden a,?, Richard Fritz b,?, Eva Maria P?llabauer a, Daniel Portsmouth b, M. Keith Howard b, Thomas R. Kreil b, Thomas Dvorak c, Sandor Fritsch c, Timo Vesikari d, J. Diez-Domingo e, Peter Richmond f, Bee Wah Lee g, Otfried Kistner b, Hartmut J. Ehrlich c, P. Noel Barrett b and Gerald Aichinger a
Author Affiliations: <SUP>a</SUP>Vaccine R&D, Baxter BioScience, Vienna, Austria; <SUP>b</SUP>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria; <SUP>c</SUP>Global R&D, Baxter BioScience, Vienna, Austria; <SUP>d</SUP>University of Tampere Medical School, Tampere, Finland; <SUP>e</SUP>Centro Superior de Investigaci?n en Salud P?blica (CSISP), Valencia, Spain; <SUP>f</SUP>University of Western Australia School of Paediatrics and Child Health, Vaccine Trials Group, Telethon Institute for Child Health Research, Princess Margaret Hospital for Children, Subiaco, WA, Australia; <SUP>g</SUP>The Child and Allergy Clinic, Mount Elizabeth Medical Centre, Singapore, Singapore
Corresponding author: Dr. Gerald Aichinger, Vaccine R&D, Baxter BioScience, IZD Tower, Wagramerstra?e 17-19, A-1220 Vienna, Austria, Email: gerald_aichinger@baxter.com, Tel:+43 1 20100 247 2060, Fax: +43 1 20100 534
? These authors contributed equally to the study
Abstract
Background.
Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines which are safe and effective in the pediatric population.
Methods.
Infants and children aged 6-35 months and 3-8 years were randomized to receive two immunizations with a 7.5 ?g or 3.75 ?g hemagglutinin (HA) dose of a non-adjuvanted whole-virus A/Vietnam strain H5N1 vaccine; adolescents aged 9-17 years received a 7.5 ?g dose only. A subset of participants received a booster immunization with an A/Indonesia strain H5N1 vaccine approximately one year later. HA and neuraminidase antibody responses were assessed.
Results.
Vaccination was safe and well-tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5 ?g dose of A/Vietnam vaccine induced virus neutralization (MN) titers ≥1:20 against the A/Vietnam strain in 68.8% to 85.4% of participants in the different age groups. After the booster, 93.1% to 100% of participants achieved MN titers ≥1:20 against the A/Vietnam and A/Indonesia strains. NA-inhibiting antibodies were induced in ≥90% of participants after two immunizations with the 7.5 ?g A/Vietnam vaccine and in 100% of participants after the booster.
Conclusions.
A whole-virus H5N1 vaccine is suitable for pre-pandemic or pandemic immunization in a pediatric population.
Clinical Trial Registration. ClinicalTrials.gov.NCT01052402
Received May 14, 2013. Revision received August 23, 2013. Accepted August 27, 2013.
? The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
For Permissions, please e-mail: journals.permissions@oup.com.
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Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in a Pediatric Population
Maikel V. W. van der Velden a,?, Richard Fritz b,?, Eva Maria P?llabauer a, Daniel Portsmouth b, M. Keith Howard b, Thomas R. Kreil b, Thomas Dvorak c, Sandor Fritsch c, Timo Vesikari d, J. Diez-Domingo e, Peter Richmond f, Bee Wah Lee g, Otfried Kistner b, Hartmut J. Ehrlich c, P. Noel Barrett b and Gerald Aichinger a
Author Affiliations: <SUP>a</SUP>Vaccine R&D, Baxter BioScience, Vienna, Austria; <SUP>b</SUP>Vaccine R&D, Baxter BioScience, Orth/Donau, Austria; <SUP>c</SUP>Global R&D, Baxter BioScience, Vienna, Austria; <SUP>d</SUP>University of Tampere Medical School, Tampere, Finland; <SUP>e</SUP>Centro Superior de Investigaci?n en Salud P?blica (CSISP), Valencia, Spain; <SUP>f</SUP>University of Western Australia School of Paediatrics and Child Health, Vaccine Trials Group, Telethon Institute for Child Health Research, Princess Margaret Hospital for Children, Subiaco, WA, Australia; <SUP>g</SUP>The Child and Allergy Clinic, Mount Elizabeth Medical Centre, Singapore, Singapore
Corresponding author: Dr. Gerald Aichinger, Vaccine R&D, Baxter BioScience, IZD Tower, Wagramerstra?e 17-19, A-1220 Vienna, Austria, Email: gerald_aichinger@baxter.com, Tel:+43 1 20100 247 2060, Fax: +43 1 20100 534
? These authors contributed equally to the study
Abstract
Background.
Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines which are safe and effective in the pediatric population.
Methods.
Infants and children aged 6-35 months and 3-8 years were randomized to receive two immunizations with a 7.5 ?g or 3.75 ?g hemagglutinin (HA) dose of a non-adjuvanted whole-virus A/Vietnam strain H5N1 vaccine; adolescents aged 9-17 years received a 7.5 ?g dose only. A subset of participants received a booster immunization with an A/Indonesia strain H5N1 vaccine approximately one year later. HA and neuraminidase antibody responses were assessed.
Results.
Vaccination was safe and well-tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5 ?g dose of A/Vietnam vaccine induced virus neutralization (MN) titers ≥1:20 against the A/Vietnam strain in 68.8% to 85.4% of participants in the different age groups. After the booster, 93.1% to 100% of participants achieved MN titers ≥1:20 against the A/Vietnam and A/Indonesia strains. NA-inhibiting antibodies were induced in ≥90% of participants after two immunizations with the 7.5 ?g A/Vietnam vaccine and in 100% of participants after the booster.
Conclusions.
A whole-virus H5N1 vaccine is suitable for pre-pandemic or pandemic immunization in a pediatric population.
Clinical Trial Registration. ClinicalTrials.gov.NCT01052402
Received May 14, 2013. Revision received August 23, 2013. Accepted August 27, 2013.
? The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
For Permissions, please e-mail: journals.permissions@oup.com.
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