Correlation of protection against Japanese encephalitis virus and JE vaccine (IXIARO ®) induced neutralizing antibody titers
Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX ® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches...
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| Published in | Vaccine Vol. 29; no. 35; pp. 5925 - 5931 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
11.08.2011
Elsevier Elsevier Limited |
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| Abstract | Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX
® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT
50 titer): high (∼200), medium (∼40–50), low (∼20) and negative (<10). Pooled sera from JE-VAX
® vaccinated subjects (PRNT
50 titer
∼
55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5
ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18
h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX
® sera protected 90–100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT
50.
Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers
≥
10 were protective. |
|---|---|
| AbstractList | Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX
® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT
50 titer): high (∼200), medium (∼40–50), low (∼20) and negative (<10). Pooled sera from JE-VAX
® vaccinated subjects (PRNT
50 titer
∼
55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5
ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18
h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX
® sera protected 90–100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT
50.
Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers
≥
10 were protective. Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX(®) and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT(50) titer): high (∼200), medium (∼40-50), low (∼20) and negative (<10). Pooled sera from JE-VAX(®) vaccinated subjects (PRNT(50) titer∼55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5 ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18 h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX(®) sera protected 90-100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT(50). Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers≥10 were protective. Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX super( registered and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT) sub(5)0 titer): high ([not, vert, similar]200), medium ([not, vert, similar]40-50), low ([not, vert, similar]20) and negative (10). Pooled sera from JE-VAX super( registered vaccinated subjects (PRNT) sub(5)0 titer [not, vert, similar] 55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5 ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18 h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX super( registered sera protected 90-100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT) sub(5)0. Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers = 10 were protective. Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT₅₀ titer): high (∼200), medium (∼40–50), low (∼20) and negative (<10). Pooled sera from JE-VAX® vaccinated subjects (PRNT₅₀ titer∼55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX® sera protected 90–100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT₅₀. Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers≥10 were protective. Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX(®) and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT(50) titer): high (∼200), medium (∼40-50), low (∼20) and negative (<10). Pooled sera from JE-VAX(®) vaccinated subjects (PRNT(50) titer∼55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5 ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18 h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX(®) sera protected 90-100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT(50). Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers≥10 were protective.Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX(®) and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT(50) titer): high (∼200), medium (∼40-50), low (∼20) and negative (<10). Pooled sera from JE-VAX(®) vaccinated subjects (PRNT(50) titer∼55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5 ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18 h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX(®) sera protected 90-100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT(50). Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers≥10 were protective. Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX®and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT50titer): high (∼200), medium (∼40-50), low (∼20) and negative (<10). Pooled sera from JE-VAX®vaccinated subjects (PRNT50titer∼55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX®sera protected 90-100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT50.Ex vivoneutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers≥10 were protective. Abstract Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO), were tested for the ability to protect mice against lethal JEV challenge. Sera from IXIARO vaccinated subjects were pooled into four batches based on neutralizing antibody measured by plaque reduction neutralization test (PRNT50 titer): high (∼200), medium (∼40–50), low (∼20) and negative (<10). Pooled sera from JE-VAX® vaccinated subjects (PRNT50 titer ∼ 55) and pooled JEV antibody negative pre-vaccination sera were used as controls. Groups of ten 6- to 7-week-old female ICR mice were injected intraperitoneally with 0.5 ml of each serum pool diluted 1:2 or 1:10, challenged approximately 18 h later with a lethal dose of either JEV strain SA14 (genotype III) or strain KE-093 (genotype I) and observed for 21 days. All mice in the non-immune serum groups developed clinical signs consistent with JEV infection or died, whereas high titer sera from both IXIARO and JE-VAX® sera protected 90–100% of the animals. Statistical tests showed similar protection against both JEV strains SA14 and KE-093 and protection correlated with the anti-JEV antibody titer of IXIARO sera as measured by PRNT50. Ex vivo neutralizing antibody titers showed that almost all mice with a titer of 10 or greater were fully protected. In a separate study, analysis of geometric mean titers (GMTs) of the groups of mice vaccinated with different doses of IXIARO and challenged with JEV SA14 provided additional evidence that titers ≥ 10 were protective. |
| Author | Van Gessel, Yvonne Dewasthaly, Shailesh Tungtaeng, Anchalee Gettayacamin, Montip Putnak, Robert Krasaesub, Somporn Formica, Alessandra Spruth, Martin Cena, Bruno Klade, Christoph S. |
| Author_xml | – sequence: 1 givenname: Yvonne surname: Van Gessel fullname: Van Gessel, Yvonne organization: Department of Veterinary Medicine, United States Army Medical Component-Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS), Bangkok, Thailand – sequence: 2 givenname: Christoph S. surname: Klade fullname: Klade, Christoph S. organization: Intercell AG, Campus Vienna Biocenter 3, Vienna, Austria – sequence: 3 givenname: Robert surname: Putnak fullname: Putnak, Robert organization: Division of Viral Diseases, Walter Reed Army Institute of Research, Silver Spring, MD, USA – sequence: 4 givenname: Alessandra surname: Formica fullname: Formica, Alessandra organization: Intercell AG, Campus Vienna Biocenter 3, Vienna, Austria – sequence: 5 givenname: Somporn surname: Krasaesub fullname: Krasaesub, Somporn organization: Department of Veterinary Medicine, United States Army Medical Component-Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS), Bangkok, Thailand – sequence: 6 givenname: Martin surname: Spruth fullname: Spruth, Martin organization: Intercell AG, Campus Vienna Biocenter 3, Vienna, Austria – sequence: 7 givenname: Bruno surname: Cena fullname: Cena, Bruno organization: Intercell AG, Campus Vienna Biocenter 3, Vienna, Austria – sequence: 8 givenname: Anchalee surname: Tungtaeng fullname: Tungtaeng, Anchalee organization: Department of Veterinary Medicine, United States Army Medical Component-Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS), Bangkok, Thailand – sequence: 9 givenname: Montip surname: Gettayacamin fullname: Gettayacamin, Montip organization: Department of Veterinary Medicine, United States Army Medical Component-Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS), Bangkok, Thailand – sequence: 10 givenname: Shailesh surname: Dewasthaly fullname: Dewasthaly, Shailesh email: sdewasthaly@intercell.com organization: Intercell AG, Campus Vienna Biocenter 3, Vienna, Austria |
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| ContentType | Journal Article |
| Copyright | 2011 Elsevier Ltd Elsevier Ltd 2015 INIST-CNRS Copyright © 2011 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Aug 11, 2011 |
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| DOI | 10.1016/j.vaccine.2011.06.062 |
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| Keywords | Ixiaro Correlation Vaccine Protection Japanese encephalitis Nervous system diseases Flavivirus Neutralizing antibody Cerebral disorder Infection Virus Viral disease Arbovirus disease Central nervous system disease Japanese encephalitis virus Japanese encephalitis group virus Flaviviridae Quantitative analysis |
| Language | English |
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virus publication-title: Vaccine – volume: 64 start-page: 156 year: 1977 end-page: 160 ident: bib0060 article-title: On distribution-free tests for equality of survival distributions publication-title: Biometrika – volume: 71 start-page: 7851 year: 1997 end-page: 7856 ident: bib0080 article-title: Immunologic correlates of protection against rotavirus challenge after intramuscular immunization of mice publication-title: J Virol – volume: 10 start-page: 861 year: 1992 end-page: 872 ident: bib0125 article-title: Antigenic characterization of the live attenuated Japanese encephalitis vaccine virus SA14-14-2: a comparison with isolates of the virus covering a wide geographic area publication-title: Vaccine – reference: > [website accessed 03.05.11]. – start-page: 919 year: 2004 end-page: 958 ident: bib0015 article-title: Japanese encephalitis vaccines publication-title: Vaccine – volume: 18 start-page: 26 year: 2000 end-page: 32 ident: bib0045 article-title: Points to consider in the development of a surrogate for efficacy of novel Japanese encephalitis virus vaccines publication-title: Vaccine – volume: 65 start-page: 242 year: 2001 end-page: 251 ident: bib0130 article-title: Phylogenetic analysis of Japanese encephalitis virus: envelope gene based analysis reveals a fifth genotype, geographic clustering, and multiple introductions of the virus into the Indian subcontinent publication-title: Am J Trop Med Hyg – volume: 21 start-page: 3675 year: 2003 end-page: 3683 ident: bib0085 article-title: Comparison of protective efficacies of plasmid DNAs encoding Japanese encephalitis virus proteins that induce neutralizing antibody or cytotoxic T lymphocytes in mice publication-title: Vaccine – volume: 60 start-page: 276 year: 2011 end-page: 278 ident: bib0010 article-title: Japanese encephalitis in two children—United States 2010 publication-title: MMWR – volume: 50 start-page: 1155 year: 2010 end-page: 1164 ident: bib0025 article-title: Japanese encephalitis: new options for active immunization publication-title: Clin Infect Dis – volume: 23 start-page: 5205 year: 2005 end-page: 5211 ident: bib0110 article-title: Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2–3 September, 2004 publication-title: Vaccine – volume: 370 start-page: 1806 year: 2007 end-page: 1808 ident: bib0040 article-title: Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial publication-title: Lancet – volume: 18 start-page: 2963 year: 2000 end-page: 2969 ident: bib0020 article-title: Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States publication-title: Vaccine – volume: 47 start-page: 401 year: 2008 end-page: 409 ident: bib0075 article-title: Correlates of vaccine-induced immunity publication-title: Clin Infect Dis – volume: 396 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| Snippet | Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX
® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO),... Abstract Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or... Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX® and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO),... Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX(®) and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO),... Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX®and a new Japanese encephalitis virus (JEV) vaccine (IC51 or IXIARO),... Immune sera from volunteers vaccinated in a blinded Phase 3 clinical trial with JE-VAX super( registered and a new Japanese encephalitis virus (JEV) vaccine... |
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| SubjectTerms | Allergy and Immunology Animals Antibodies, Neutralizing - blood Antibodies, Viral - blood antiserum Applied microbiology Arboviral encephalitis Arboviroses Automation Biological and medical sciences blood serum Brain research Cell culture clinical trials Correlation Dilution Encephalitis Virus, Japanese - immunology Encephalitis Virus, Japanese - pathogenicity Encephalitis, Japanese - immunology Encephalitis, Japanese - mortality Encephalitis, Japanese - prevention & control Encephalitis, Japanese - virology Female Fundamental and applied biological sciences. Psychology genotype Human viral diseases Humans Immune Sera - administration & dosage Immune Sera - immunology Immunization Immunization, Passive Infectious diseases Ixiaro Japanese encephalitis Japanese Encephalitis Vaccines - administration & dosage Japanese Encephalitis Vaccines - immunology Japanese encephalitis virus lethal dose Male Medical sciences Mice Mice, Inbred ICR Microbiology Miscellaneous Neutralization Neutralization Tests neutralizing antibodies Protection Survival Analysis Treatment Outcome Tropical viral diseases Vaccine Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vector-borne diseases Viral diseases Virology volunteers |
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| Title | Correlation of protection against Japanese encephalitis virus and JE vaccine (IXIARO ®) induced neutralizing antibody titers |
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