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Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naïve Children
C. Claeys, V. Chandrasekaran, J. García-Sicilia, R. Prymula, J. Díez-Domingo, J. Brzostek, J. Marès-Bermúdez, F. Martinón-Torres, AJ. Pollard, R. Růžková, A. Carmona Martinez, A. Ulied, M. Miranda Valdivieso, SN. Faust, MD. Snape, D. Friel, T....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- chřipka lidská prevence a kontrola MeSH
- imunologická paměť * MeSH
- inaktivované vakcíny aplikace a dávkování škodlivé účinky imunologie MeSH
- kojenec MeSH
- lidé MeSH
- neutralizační testy MeSH
- neutralizující protilátky krev MeSH
- nežádoucí účinky léčiv epidemiologie patologie MeSH
- předškolní dítě MeSH
- protilátky virové krev MeSH
- testy inhibice hemaglutinace MeSH
- vakcíny proti chřipce aplikace a dávkování škodlivé účinky imunologie MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: It has not yet been demonstrated whether 2 doses of inactivated quadrivalent influenza vaccine (IIV4) prime a booster response in infants. We evaluated the anamnestic immune response to an IIV4 in children 17-48 months of age. METHODS: Children were randomized to 2 doses of IIV4 or control in the primary phase III study (NCT01439360). One year later, in an open-label revaccination extension study (NCT01702454), a subset of children who received IIV4 in the primary study (primed group) received 1 IIV4 dose and children who received control in the primary study (unprimed) received 2 IIV4 doses 28 days apart. The primary objective was to evaluate hemagglutination inhibition (HI) antibody titers 7 days after first IIV4 vaccination in the per-protocol cohort (N = 224 primed; N = 209 unprimed). Neutralizing and antineuraminidase antibodies were also measured. Safety was analyzed in the total vaccinated cohort (N = 241 primed; N = 229 unprimed). RESULTS: An anamnestic response was observed in primed children relative to unprimed controls, measured by age-adjusted geometric mean HI titer ratios against strains homologous (A/H1N1: 9.0; B/Victoria: 3.9) and heterologous (A/H3N2: 2.7; B/Yamagata: 6.7) to those in the primary vaccination series. The anamnestic response in primed children included increases in neutralizing antibodies (mean geometric increase: 5.0-10.6) and antineuraminidase antibodies (4.9-8.8). No serious adverse events related to vaccination were reported. CONCLUSIONS: In this study, 2-dose priming with IIV4 induced immune memory that was recalled with 1-dose IIV4 the following year to boost HI, antineuraminidase and neutralizing antibodies, even though the IIV4 strain composition partially changed.
Faculty of Medicine University Hospital and Charles University Hradec Králové Czech Republic
GSK King of Prussia Pennsylvania
Hospital de Antequera Málaga Spain
Hospital Materno Infantil La Paz Madrid Spain
Infectious Diseases Outpatient Clinic Debica Poland
Institut Pediàtric Marès Riera Girona Spain
Instituto Hispalense de Pediatría Sevilla Spain
Pediatric Office Dr Renáta Růžková Prague Czech Republic
University of Oxford and the NIHR Oxford Biomedical Research Centre Oxford United Kingdom
Vaccine Research Department FISABIO Public Health Valencia Spain
Citace poskytuje Crossref.org
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- $a BACKGROUND: It has not yet been demonstrated whether 2 doses of inactivated quadrivalent influenza vaccine (IIV4) prime a booster response in infants. We evaluated the anamnestic immune response to an IIV4 in children 17-48 months of age. METHODS: Children were randomized to 2 doses of IIV4 or control in the primary phase III study (NCT01439360). One year later, in an open-label revaccination extension study (NCT01702454), a subset of children who received IIV4 in the primary study (primed group) received 1 IIV4 dose and children who received control in the primary study (unprimed) received 2 IIV4 doses 28 days apart. The primary objective was to evaluate hemagglutination inhibition (HI) antibody titers 7 days after first IIV4 vaccination in the per-protocol cohort (N = 224 primed; N = 209 unprimed). Neutralizing and antineuraminidase antibodies were also measured. Safety was analyzed in the total vaccinated cohort (N = 241 primed; N = 229 unprimed). RESULTS: An anamnestic response was observed in primed children relative to unprimed controls, measured by age-adjusted geometric mean HI titer ratios against strains homologous (A/H1N1: 9.0; B/Victoria: 3.9) and heterologous (A/H3N2: 2.7; B/Yamagata: 6.7) to those in the primary vaccination series. The anamnestic response in primed children included increases in neutralizing antibodies (mean geometric increase: 5.0-10.6) and antineuraminidase antibodies (4.9-8.8). No serious adverse events related to vaccination were reported. CONCLUSIONS: In this study, 2-dose priming with IIV4 induced immune memory that was recalled with 1-dose IIV4 the following year to boost HI, antineuraminidase and neutralizing antibodies, even though the IIV4 strain composition partially changed.
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