Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population

M.V.W. Van Der Velden; R.S. Fritz; E.M. Pöllabauer; D. Portsmouth; M.K. Howard; T.R. Kreil; T. Dvorak; S. Fritsch; T.H. Vesikari; J. Díez Domingo; Peter Richmond; B. Lee; O. Kistner; H.J. Ehrlich; P.N. Barrett; G. Aichinger

doi:10.1093/infdis/jit498

Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population

M.V.W. Van Der Velden, R.S. Fritz, E.M. Pöllabauer, D. Portsmouth, M.K. Howard, T.R. Kreil, T. Dvorak, S. Fritsch, T.H. Vesikari, J. Díez Domingo, Peter Richmond, B. Lee, O. Kistner, H.J. Ehrlich, P.N. Barrett, G. Aichinger

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Abstract

Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population.Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-g or 3.75-g hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(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(H5N1) vaccine approximately 1 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 microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 g A/Vietnam vaccine and in 100% of participants after the booster.Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population.Clinical Trials Registration. NCT01052402. © 2013 The Author.

Original language	English
Pages (from-to)	12-23
Journal	Journal of Infectious Diseases
Volume	209
Issue number	1
DOIs	https://doi.org/10.1093/infdis/jit498
Publication status	Published - 2014

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Van Der Velden, M. V. W., Fritz, R. S., Pöllabauer, E. M., Portsmouth, D., Howard, M. K., Kreil, T. R., Dvorak, T., Fritsch, S., Vesikari, T. H., Díez Domingo, J., Richmond, P., Lee, B., Kistner, O., Ehrlich, H. J., Barrett, P. N., & Aichinger, G. (2014). Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population. Journal of Infectious Diseases, 209(1), 12-23. https://doi.org/10.1093/infdis/jit498

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title = "Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population",

abstract = "Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population.Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-g or 3.75-g hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(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(H5N1) vaccine approximately 1 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 microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 g A/Vietnam vaccine and in 100% of participants after the booster.Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population.Clinical Trials Registration. NCT01052402. {\textcopyright} 2013 The Author.",

author = "{Van Der Velden}, M.V.W. and R.S. Fritz and E.M. P{\"o}llabauer and D. Portsmouth and M.K. Howard and T.R. Kreil and T. Dvorak and S. Fritsch and T.H. Vesikari and {D{\'i}ez Domingo}, J. and Peter Richmond and B. Lee and O. Kistner and H.J. Ehrlich and P.N. Barrett and G. Aichinger",

year = "2014",

doi = "10.1093/infdis/jit498",

language = "English",

volume = "209",

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Van Der Velden, MVW, Fritz, RS, Pöllabauer, EM, Portsmouth, D, Howard, MK, Kreil, TR, Dvorak, T, Fritsch, S, Vesikari, TH, Díez Domingo, J, Richmond, P, Lee, B, Kistner, O, Ehrlich, HJ, Barrett, PN & Aichinger, G 2014, 'Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population', Journal of Infectious Diseases, vol. 209, no. 1, pp. 12-23. https://doi.org/10.1093/infdis/jit498

TY - JOUR

T1 - Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population

AU - Van Der Velden, M.V.W.

AU - Fritz, R.S.

AU - Pöllabauer, E.M.

AU - Portsmouth, D.

AU - Howard, M.K.

AU - Kreil, T.R.

AU - Dvorak, T.

AU - Fritsch, S.

AU - Vesikari, T.H.

AU - Díez Domingo, J.

AU - Richmond, Peter

AU - Lee, B.

AU - Kistner, O.

AU - Ehrlich, H.J.

AU - Barrett, P.N.

AU - Aichinger, G.

PY - 2014

Y1 - 2014

N2 - Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population.Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-g or 3.75-g hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(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(H5N1) vaccine approximately 1 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 microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 g A/Vietnam vaccine and in 100% of participants after the booster.Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population.Clinical Trials Registration. NCT01052402. © 2013 The Author.

AB - Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population.Methods. Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-g or 3.75-g hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(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(H5N1) vaccine approximately 1 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 microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 g A/Vietnam vaccine and in 100% of participants after the booster.Conclusions. A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population.Clinical Trials Registration. NCT01052402. © 2013 The Author.

U2 - 10.1093/infdis/jit498

DO - 10.1093/infdis/jit498

M3 - Article

VL - 209

SP - 12

EP - 23

JO - Journal Infectious Diseases

JF - Journal Infectious Diseases

SN - 0022-1899

IS - 1

ER -

Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population

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