A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in women of childbearing age

A phase 2 randomized-controlled safety and immunogenicity trial evaluating different doses of recombinant acellular pertussis vaccine containing genetically-inactivated pertussis toxin (PTgen) was conducted in women of childbearing age in Thailand to identify formulations to advance to a trial in pregnant women. Methods A total of 250 women were randomized 1:1:1:1:1 to receive one dose of one of three investigational vaccines including low-dose recombinant pertussis-only vaccine containing 1 μg PTgen and 1 μg FHA (ap1gen), tetanus, reduced-dose diphtheria (Td) combined to ap1gen (Tdap1gen) or combined to recombinant pertussis containing 2 μg PTgen and 5 μg FHA (Tdap2gen), or one dose of licensed recombinant TdaP vaccine containing 5 μg PTgen and 5 μg FHA (Boostagen®, TdaP5gen) or licensed Tdap vaccine containing 8 μg of chemically inactivated pertussis toxoid (PTchem), 8 μg FHA, and 2.5 μg pertactin (PRN) (BoostrixTM, Tdap8chem). Serum Immunoglobulin G (IgG) antibodies against vaccine antigens were measured before and 28 days after vaccination by ELISA. To advance to a trial in pregnant women, formulations had to induce a PT-IgG seroresponse rate with a 95% confidence interval (95% CI) lower limit of ≥ 50%. Results Between 5 and 22 July 2018, a total of 250 women with median age of 31 years were enrolled. Post-vaccination PT-IgG seroresponse rates were 92% (95% CI 81–98) for ap1gen, 88% (95% CI 76–95) for Tdap1gen, 80% (95% CI 66–90) for Tdap2gen, 94% (95% CI 83–99) for TdaP5gen, and 78% (95% CI 64–88) for Tdap8chem. Frequencies of injection site and systemic reactions were comparable between the groups. No serious adverse events were reported during the 28-day post-vaccination period. Conclusions All recombinant acellular pertussis vaccines were safe and immunogenic in women of childbearing age, and all met pre-defined immunogenicity criteria to advance to a trial in pregnant women. Source: ScienceDirect Acellular Pertussis Vaccine, aP, childbearing ages, Diphtheria, genetically detoxified pertussis toxin, immunoginicity, Pertussis, recombinant pertussis, Tdap, tetanus, vaccination, vaccine Search News categories BioNet News (29) Events (8) Biotech News (60) Thailand (2) Covid-19 (2) News tags Acellular Pertussis Vaccine (5) Adolescent (3) AI (3) aP (5) Artificial Intelligence (5) biotechnology (12) booster vaccine (3) Bordetella pertussis (9) cancer (8) Cancer vaccine (5) covid-19 (22) COVID-19 vaccine (3) Diphtheria (7) DNA (3) Flu (3) genetically detoxified pertussis toxin (6) Immune Response (8) immune system (12) Immunization (5) immunoginicity (5) infectious disease (4) infectious diseases (4) maternal immunization (3) mRNA (14) mRNA Technology (7) pandemic (8) Pertussis (9) Pertussis Toxin (4) pertussis vaccine (5) PT (5) PTgen (5) respiratory diseases (4) RNA (4) SARS-CoV-2 (8) Tdap (8) tetanus (6) Tuberculosis (3) vaccination (10) vaccine (35) Vaccine Development (10) vaccines (4) Vaccine Storage (3) virus (3) Whooping Cough (8) Whoopingcough (4) Recent News Hybrid Nanocarriers Could Enable Targeted Vaccine Delivery in the Lungs January 22, 2026 The golden age of vaccine development January 19, 2026 The European Commission Grants Marketing Authorisation for a First-of-its-Kind Pertussis-Only Vaccine for Vaccination of Teenagers, Adults and Pregnant Women in the European Union January 15, 2026 New Pertussis Vaccine Set for Implementation December 20, 2025 BioNet Receives Positive CHMP Opinion from EMA for VacPertagen, a Recombinant Vaccine Against Pertussis November 21, 2025 Subscribe Terms of use Privacy 2026© BioNet-Asia. All rights reserved. We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok

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