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
Parallel
Maternal TdaP2gen vaccine
Biological/VaccineA combined tetanus toxoid, reduced diphtheria toxoid, reduced-dose (2 µg) genetically-detoxified recombinant acellular pertussis vaccine (TdaP2gen)
Infant Acellular Pertussis-containing Vaccine
Biological/VaccineAn infant acellular pertussis (aP)-containing vaccine
Infant Whole-cell Pertussis-containing Vaccine
Biological/VaccineAn infant whole-cell pertussis (wP)-containing vaccine
Phase 1: Maternal anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid, and anti-tetanus toxoid immunoglobulin G (IgG) geometric mean concentrations and seroresponse rates following TdaP2gen vaccination during pregnancy
Assessment of maternal anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates before TdaP2gen vaccination, after vaccination, and at delivery
Phase 1: Cord blood anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates at birth
Assessment of anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates in cord blood collected at delivery among infants born to TdaP2gen vaccinated mothers
Phase 1: Incidence of solicited local and systemic adverse events, serious adverse events, and adverse pregnancy outcomes of TdaP2gen vaccination during pregnancy
Assessment of solicited local and systemic adverse events as well as serious adverse events and adverse pregnancy outcomes among pregnant women receiving TdaP2gen vaccination during pregnancy.
Phase 2: Infant anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates following primary diphtheria-tetanus-pertussis vaccination series
Assessment and comparison of anti-PT, anti-FHA, anti-diphtheria toxoid, and anti-tetanus toxoid IgG geometric mean concentrations and seroresponse rates between infants born to mothers receiving TdaP2gen vaccine during pregnancy who are randomized to receive either aP- or wP-containing vaccines as the primary vaccination series during infancy
Phase 1: Maternal pertussis-neutralizing antibody geometric mean titers following TdaP2gen vaccination during pregnancy
Assessment of maternal pertussis-neutralizing antibody geometric mean titers in a subset of 40 pregnant women before TdaP2gen vaccination, after vaccination, and at delivery
Phase 1: Cord blood pertussis-neutralizing antibody geometric mean titers at birth
Assessment of pertussis-neutralizing antibody geometric mean titers in cord blood samples from newborns of a subset of 40 vaccinated pregnant women at delivery
Phase 1: Knowledge and acceptability of pertussis and pertussis vaccine among pregnant women assessed using a structured questionnaire
Assessment of knowledge and acceptability of pertussis and pertussis vaccine among pregnant women using a structured questionnaire
Phase 2: Infant pertussis-neutralizing antibody geometric mean titers following primary diphtheria-tetanus-pertussis vaccination series
Assessment and comparison of pertussis-neutralizing antibody geometric mean titers in a subset of 40 infants born to mothers receiving TdaP2gen vaccine during pregnancy who are randomized to receive either aP- or wP-containing vaccines as the primary vaccination series during infancy
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Chiang Mai University
Lead sponsor
Thailand Center of Excellence for Life Sciences
Collaborator
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