Background: A phase 2 randomized-controlled safety and immunogenicity trial evaluating different doses of recombinant acellular pertussis vaccine containing genetically-inactivated pertussis toxin (PT) 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 PT and 1 μg FHA (ap1), tetanus, reduced-dose diphtheria (Td) combined to ap1 (Tdap1) or combined to recombinant pertussis containing 2 μg PT and 5 μg FHA (Tdap2), or one dose of licensed recombinant TdaP vaccine containing 5 μg PT and 5 μg FHA (Boostagen®, TdaP5) or licensed Tdap vaccine containing 8 μg of chemically inactivated pertussis toxoid (PT), 8 μg FHA, and 2.5 μg pertactin (PRN) (Boostrix, Tdap8). 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 ap1, 88% (95% CI 76-95) for Tdap1, 80% (95% CI 66-90) for Tdap2, 94% (95% CI 83-99) for TdaP5, and 78% (95% CI 64-88) for Tdap8. 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.
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| http://dx.doi.org/10.1016/j.vaccine.2021.10.076 | DOI Listing |
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