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Clin Infect Dis ; 68(7): 1213-1222, 2019 03 19.
Artículo en Inglés | MEDLINE | ID: mdl-30759183

RESUMEN

BACKGROUND: Protection induced by acellular pertussis (aP) vaccines is partial and short-lived, especially in teenagers, calling for novel immunization strategies. METHODS: We conducted an investigator-driven proof-of-concept randomized controlled trial in aP-primed adolescents in Geneva to assess the immunogenicity and reactogenicity of a novel recombinant aP (r-aP) vaccine including recombinant pertussis toxin (PT) and filamentous hemagglutinin (FHA) coadministered with tetanus-diphtheria toxoids (Td), compared to a licensed tetanus-diphtheria-aP vaccine containing chemically detoxified PT (cd/Tdap). The primary immunological endpoints were day 28/365 geometric mean concentrations (GMCs) of total and neutralizing anti-PT antibodies. Memory B cells were assessed. RESULTS: Sixty-two aP-primed adolescents were randomized and vaccinated with r-aP + Td or cd/Tdap. Reactogenicity, adverse events, and baseline GMCs were similar between the groups. Day 28 PT-neutralizing GMCs were low after cd/Tdap (73.91 [95% confidence interval {CI}, 49.88-109.52] IU/mL) and approximately 2-fold higher after r-aP + Td (127.68 [95% CI, 96.73-168.53] IU/mL; P = .0162). Anti-PT GMCs were also low after cd/Tdap (52.43 [95% CI, 36.41-75.50] IU/mL) and 2-fold higher after r-aP + Td (113.74 [95% CI, 88.31-146.50] IU/mL; P = .0006). Day 28 anti-FHA GMCs were similar in both groups. Day 365 anti-PT (but not PT-neutralizing) GMCs remained higher in r-aP + Td vaccinees. PT-specific memory B cells increased significantly after r-aP + Td but not cd/Tdap boosting. CONCLUSIONS: Boosting aP-primed adolescents with r-aP induced higher anti-PT and PT-neutralizing responses than cd/Tdap and increased PT-specific memory B cells. Despite this superior immunogenicity, r-aP may have to be given repeatedly, earlier, and/or with novel adjuvants to exert an optimal influence in aP-primed subjects. CLINICAL TRIALS REGISTRATION: NCT02946190.


Asunto(s)
Anticuerpos Neutralizantes/sangre , Inmunización Secundaria/métodos , Toxina del Pertussis/inmunología , Vacuna contra la Tos Ferina/inmunología , Tos Ferina/prevención & control , Adhesinas Bacterianas/genética , Adhesinas Bacterianas/inmunología , Adolescente , Anticuerpos Antibacterianos/sangre , Antitoxinas/sangre , Subgrupos de Linfocitos B/inmunología , Niño , Femenino , Humanos , Memoria Inmunológica , Masculino , Toxina del Pertussis/genética , Vacuna contra la Tos Ferina/administración & dosificación , Suiza , Vacunas Acelulares/administración & dosificación , Vacunas Acelulares/inmunología , Vacunas Sintéticas/administración & dosificación , Vacunas Sintéticas/inmunología , Factores de Virulencia de Bordetella/genética , Factores de Virulencia de Bordetella/inmunología
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