A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in women of childbearing age
| Autor: | Simonetta Viviani, Bruce L. Innis, Hong Thai Pham, Niranjan Bhat, Indah Andi-Lolo, Librada Fortuna, Supattra Rungmaitree, Keswadee Lapphra, Renee Holt, Thanyawee Puthanakit, Souad Mansouri, Chawanee Kerdsomboon, Kulkanya Chokephaibulkit, Yuxiao Tang, Anita H. J. van den Biggelaar, Pailinrut Chinwangso, Watsamon Jantarabenjakul, Ladda Suwitruengrit, Suvaporn Anugulruengkitt |
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| Rok vydání: | 2022 |
| Předmět: |
Adult
medicine.medical_specialty Whooping Cough Immunization Secondary Diphtheria-Tetanus-acellular Pertussis Vaccines Pertussis toxin Pregnancy Internal medicine medicine Humans Adverse effect Diphtheria-Tetanus-Pertussis Vaccine General Veterinary General Immunology and Microbiology Tetanus business.industry Diphtheria Immunogenicity Public Health Environmental and Occupational Health medicine.disease Antibodies Bacterial Vaccination Clinical trial Infectious Diseases Pertussis Toxin Molecular Medicine Female Pertactin business |
| Zdroj: | Vaccine. 40:2352-2361 |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2021.10.076 |
| Popis: | Background 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. Clinical Trial Registration: Thai Clinical Trial Registry, TCTR20180321004. |
| Databáze: | OpenAIRE |
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