Vaccine · 2026
Safety and immunogenicity of a genetically inactivated stand-alone acellular pertussis vaccine as a booster to Australian adults: a randomized, controlled, non-inferiority trial.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Ong Madeline M, van den Biggelaar Anita H J, Goh Leonard, Hutton Heidi, Fortuna Librada, Yuwaree Vilasinee, Kerdsomboon Chawanee, Mansouri Souad, Thai Pham Hong, Richmond Peter C, Wadia Ushma
Аннотация
INTRODUCTION: Waning immunity after acellular pertussis (aP) vaccines shown in pertussis outbreaks highlights the need for more effective aP vaccines. We evaluated the immunogenicity and safety of a stand-alone 2-component aP vaccine (aP2) containing genetically inactivated pertussis toxin (PT) and filamentous hemagglutinin (FHA) compared with a licensed 3-component Tdap vaccine (Tdap3) containing chemically inactivated PT, FHA, and pertactin (PRN) in adults.
METHODS: This randomized controlled trial enrolled 102 healthy Australian adults aged 18-30 years. Participants were randomized 2:1 (aP2: Tdap3) with stratification for priming in infancy with whole-cell (wP) or aP vaccines. Immunogenicity was assessed measuring serum PT-IgG, FHA-IgG and PT-neutralizing antibodies (PTNA) at baseline, Day-28 and 1-year post-vaccination. Seroconversion was defined as ≥4-fold rise in antibody titers from baseline. Safety was monitored throughout.
RESULTS: Day 28 seroconversion rates for PT-IgG were 98.5% (95% CI 91.7-100.0) for aP2 and 82.4% (65.5-93.2) for Tdap3 (Δ, absolute difference = 16.1%) and for FHA-IgG 87.7% (77.2-94.5) for aP2 and 61.8% (43.6-77.8) for Tdap3 (Δ25.9%), meeting the pre-defined seroconversion non-inferiority margin of > - 10%. Geometric mean concentrations/titers of PT-IgG and PTNA were significantly higherin the aP2 group compared to Tdap3 at 28 days (PT-IgG 132.70 IU/mL vs. 57.42 IU/mL, p = 0.0001; PTNA 146.97 IU/mL vs. 69.32 IU/mL, p = 0.0010) and 1-year post-vaccination (PT-IgG 27.61 IU/mL vs. 12.51 IU/mL, p = 0.0099; PTNA 31.02 IU/mL vs. 15.70 IU/mL, p = 0.0100). Exploratory analysis showed aP2 elicited higher PT-IgG and PTNA titers in both wP- and aP-primed adults at both timepoints. Safety profiles were comparable between vaccines, with most adverse events being mild to moderate. Four serious adverse events were reported throughout the study, none of which were vaccine-related.
CONCLUSION: These findings suggest that aP2 vaccine is safe and more immunogenic in adults compared with Tdap3 vaccine, supporting its use as a pertussis booster.
METHODS: This randomized controlled trial enrolled 102 healthy Australian adults aged 18-30 years. Participants were randomized 2:1 (aP2: Tdap3) with stratification for priming in infancy with whole-cell (wP) or aP vaccines. Immunogenicity was assessed measuring serum PT-IgG, FHA-IgG and PT-neutralizing antibodies (PTNA) at baseline, Day-28 and 1-year post-vaccination. Seroconversion was defined as ≥4-fold rise in antibody titers from baseline. Safety was monitored throughout.
RESULTS: Day 28 seroconversion rates for PT-IgG were 98.5% (95% CI 91.7-100.0) for aP2 and 82.4% (65.5-93.2) for Tdap3 (Δ, absolute difference = 16.1%) and for FHA-IgG 87.7% (77.2-94.5) for aP2 and 61.8% (43.6-77.8) for Tdap3 (Δ25.9%), meeting the pre-defined seroconversion non-inferiority margin of > - 10%. Geometric mean concentrations/titers of PT-IgG and PTNA were significantly higherin the aP2 group compared to Tdap3 at 28 days (PT-IgG 132.70 IU/mL vs. 57.42 IU/mL, p = 0.0001; PTNA 146.97 IU/mL vs. 69.32 IU/mL, p = 0.0010) and 1-year post-vaccination (PT-IgG 27.61 IU/mL vs. 12.51 IU/mL, p = 0.0099; PTNA 31.02 IU/mL vs. 15.70 IU/mL, p = 0.0100). Exploratory analysis showed aP2 elicited higher PT-IgG and PTNA titers in both wP- and aP-primed adults at both timepoints. Safety profiles were comparable between vaccines, with most adverse events being mild to moderate. Four serious adverse events were reported throughout the study, none of which were vaccine-related.
CONCLUSION: These findings suggest that aP2 vaccine is safe and more immunogenic in adults compared with Tdap3 vaccine, supporting its use as a pertussis booster.
Предметные рубрики MeSH
HumansAntibodies, BacterialAdultFemaleAustraliaImmunization, SecondaryYoung AdultImmunoglobulin GWhooping CoughMaleVaccines, InactivatedAdolescentDiphtheria-Tetanus-acellular Pertussis VaccinesPertussis VaccineAntibodies, NeutralizingImmunogenicity, VaccineVaccines, AcellularPertussis ToxinVirulence Factors, BordetellaAdhesins, BacterialBacterial Outer Membrane Proteins