Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks' gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination administered as a primary series at 2, 4, and 6 months and booster doses at 18 months and 4-6 years of age.
TdaP2gen, a newly developed combined tetanus, diphtheria, and recombinant genetically detoxified acellular pertussis vaccine containing 2 µg pertussis antigen, has shown favorable safety and non-inferior immunogenicity compared with existing pertussis vaccines. However, data on its use in pregnant women, transplacental antibody transfer, and potential immune interference in infants remain limited.
This study aims to evaluate the safety and immunogenicity of TdaP2gen in pregnant women, assess antibody transfer to newborns, and investigate immune responses to tetanus, diphtheria, and pertussis following primary and booster pertussis-containing vaccinations in infants and toddlers, including comparisons between whole-cell and acellular pertussis-containing vaccine schedules.
Pregnant women aged 20 to 45 years
Healthy women in good general health
Gestational age between 20 and 32 weeks at enrollment
Singleton pregnancy
Receipt of a tetanus-, diphtheria-, and chemical-detoxified pertussis-containing vaccine within 1 year prior to enrollment, or receipt of a tetanus-, diphtheria-, and genetic-detoxified pertussis-containing vaccine (TdaPgen) or genetic-detoxified acellular pertussis vaccine (aPgen) within 2 years prior to enrollment, including during the current pregnancy
History of laboratory-confirmed or clinically diagnosed pertussis infection within 1 year prior to enrollment
Presence of underlying medical conditions that may affect study outcomes, including but not limited to malignancy, autoimmune disease, immunodeficiency, epilepsy, hypertension, renal disease, or liver disease, as determined by the investigators
Pregnancy complications including hypertension (blood pressure >140/90 mmHg with proteinuria, or >150/100 mmHg regardless of proteinuria), current antihypertensive treatment, or preeclampsia
Chiang Mai University
Lead sponsor
Thailand Center of Excellence for Life Sciences
Collaborator