Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children
Claeys, C.; Chandrasekaran, V.; Garcia-Sicilia, J.; Prymula, R.; Diez-Domingo, J.; Brzostek, J.; Mares-Bermudez, J.; Martinón Torres, Federico; Pollard, A. J.; Ruzkova, R.; Martinez, A. C.; Ulied, A.; Valdivieso, M. M.; Faust, S. N.; Snape, M. D.; Friel, D.; Ollinger, T.; Soni, J.; Schuind, A.; Li, P.; Innis, B. L.; Jain, V. K.
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Identificadores
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Fecha de publicación
2019Título de revista
PEDIATRIC INFECTIOUS DISEASE JOURNAL
Tipo de contenido
Artigo
DeCS
efectos colaterales y reacciones adversas relacionados con medicamentos | vacunas de la gripe | vacunas | lactante | humanos | anticuerpos | pruebas de neutralización | pruebas de inhibición de la hemaglutinación | memoria inmunológicaMeSH
Drug-Related Side Effects and Adverse Reactions | Neutralization Tests | Humans | Antibodies | Influenza Vaccines | Immunologic Memory | Hemagglutination Inhibition Tests | Vaccines | InfantResumen
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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