| Autor: |
Martinón-Torres F; Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.; Genetics, Vaccines and Infectious Diseases Research Group (GENvip), Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago de Compostela, Santiago de Compostela, Spain.; Consorcio Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain., Salamanca de la Cueva I; Instituto Hispalense de Pediatría, Sevilla, Spain., Horn M; Praxis Dr. med. Michael Horn, Bayern, Schoenau am Koenigssee, Germany., Westerholt S; Praxis für Kinder und Jugendmedizin Drs. Westerholt/Matyas, Wolfsburg, Germany., Bosis S; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy., Meyer N; GSK, Wavre, Belgium., Cheuvart B; GSK, Wavre, Belgium., Virk N; GSK, Mumbai, India., Jakes RW; GSK, London, UK., Duchenne M; GSK, Wavre, Belgium., Van den Steen P; GSK, Wavre, Belgium. |
| Abstrakt: |
Since the introduction of Haemophilus Influenzae type b (Hib) conjugate vaccines, invasive Hib disease has strongly declined worldwide, yet continued control of Hib disease remains important. In Europe, currently three different hexavalent combination vaccines containing Hib conjugates are marketed. In this phase IV, single-blind, randomized, controlled, multi-country study (NCT04535037), we aimed to compare, in a 2 + 1 vaccination schedule, the immunogenicity and safety and show non-inferiority, as well as superiority, of DTPa-HBV-IPV/Hib (Ih group) versus DTaP5-HB-IPV-Hib (Va group) in terms of anti-polyribosylribitol phosphate (PRP) antibody geometric mean concentrations (GMCs) and proportion of participants reaching anti-PRP antibody concentrations greater than or equal to a threshold of 5 µg/mL. One month after the booster vaccination, the anti-PRP antibody GMC ratio (Ih group/Va group) was 0.917 (95% CI: 0.710-1.185), meeting the non-inferiority criteria. The difference in percentage of participants (Ih group - Va group) reaching GMCs ≥5 µg/mL was -6.3% (95% CI: -14.1% to 1.5%), not reaching the predefined non-inferiority threshold. Interestingly, a slightly higher post-booster antibody avidity was observed in the Ih group versus the Va group. Both vaccines were well tolerated, and no safety concerns were raised. This study illustrates the different kinetics of the anti-PRP antibody response post-primary and post-booster using the two vaccines containing different Hib conjugates and indicates a potential differential impact of concomitant vaccinations on the anti-PRP responses. The clinical implications of these differences should be further studied. |
