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

• DOI: 10.1016/j.vaccine.2021.10.076
• Publication Date: 2021-11-14T12:01:28Z
• Authors: Kulkanya Chokepha...; Thanyawee Puthanakit; Niranjan Bhat; Souad Mansouri; Yuxiao Tang; Keswadee Lapphra; Supattra Rungmaitree; Suvaporn Anugulru...; Watsamon Jantarab...; Indah Andi-Lolo; Renee Holt; Librada Fortuna; Chawanee Kerdsomboon; Pailinrut Chinwangso; Ladda Suwitruengrit; Anita H.J. van de...; Simonetta Viviani; Hong Thai Pham; Bruce L. Innis
• Keywords: Pertactin; Booster dose; Toxoid; Whooping cough; Pertussis vaccine; Diphtheria Toxin

A phase 2 randomized-controlled safety and immunogenicity trial evaluating different doses of recombinant acellular pertussis vaccine containing genetically-inactivated toxin (PTgen) was conducted in women childbearing age Thailand to identify formulations advance a pregnant women. total 250 were randomized 1:1:1:1:1 receive one dose three investigational vaccines including low-dose pertussis-only 1 μg PTgen FHA (ap1gen), tetanus, reduced-dose diphtheria (Td) combined ap1gen (Tdap1gen) or 5 (Tdap2gen), licensed TdaP (Boostagen®, TdaP5gen) Tdap 8 chemically inactivated toxoid (PTchem), FHA, 2.5 pertactin (PRN) (BoostrixTM, Tdap8chem). Serum Immunoglobulin G (IgG) antibodies against antigens measured before 28 days after vaccination by ELISA. To women, had induce PT-IgG seroresponse rate with 95% confidence interval (95% CI) lower limit ≥ 50%. Between 22 July 2018, median 31 years enrolled. Post-vaccination rates 92% CI 81–98) for ap1gen, 88% 76–95) Tdap1gen, 80% 66–90) Tdap2gen, 94% 83–99) TdaP5gen, 78% 64–88) Tdap8chem. Frequencies injection site systemic reactions comparable between the groups. No serious adverse events reported during 28-day post-vaccination period. All safe immunogenic age, all met pre-defined criteria Clinical Trial Registration: Thai Registry, TCTR20180321004.