Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial. Issue 8 (18th February 2020)

• Record Type: Journal Article
• Authors: Perrett, Kirsten P.; Halperin, Scott A.; Nolan, Terry; Carmona Martínez, Alfonso; Martinón-Torres, Federico; García-Sicilia, Jose; Virta, Miia; Vanderkooi, Otto G.; Zuccotti, Gian Vincenzo; Manzoni, Paolo; Kostanyan, Lusine; Meyer, Nadia; Ceregido, Maria Angeles; Cheuvart, Brigitte; Kuriyakose, Sherine O.; Stranak, Zbynek; Merino Arribas, Jose M.; Cilleruelo Ortega, María José; Miranda-Valdivieso, Mariano; Arias Novas, Begoña; Ramos Amador, Jose Tomas; Omeñaca, Felix; Baca, Manuel; Marchisio, Paola Giovanna; Mesaros, Narcisa
• Is Part Of: Vaccine. Volume 38:Issue 8(2020)
• Page Start: 2105
• Page End: 2114
• Publication Date: 2020-02-18
• Subjects: Tdap vaccine -- Pertussis -- Maternal immunization -- Blunting -- Infants; AE adverse event -- ATP according-to-protocol -- CI confidence interval -- CPS capsular polysaccharide -- DTaP-HepB-IPV/Hib diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated poliovirus and Haemophilus influenzae type b vaccine -- ECL electrochemiluminescence -- ELISA enzyme-linked immunosorbent assay -- FHA filamentous hemagglutinin -- HBs hepatitis B surface antigen -- GMC geometric mean concentration -- GMT geometric mean titer -- Hib Haemophilus influenzae type b -- LLoQ lower limit of quantitation -- PCV13 13-valent pneumococcal conjugate vaccine -- PRN pertactin -- PRP polyribosylribitol phosphate -- PT pertussis toxoid -- RCT randomized controlled trial -- SAE serious adverse event -- Tdap diphtheria-tetanus-acellular pertussis vaccine -- TVC total vaccinated cohort; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2019.10.104
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Infants of mothers who participated in a phase IV maternal pertussis immunization trial (NCT02377349) received hexavalent DTaP and PCV13 primary series. High levels of maternally transferred pertussis antibodies persisted in infants from Tdap-vaccinated mothers until 2–3 months after birth. These maternally transferred pertussis antibodies interfered with the infant immune response to the pertussis components of the primary DTaP series. The clinical significance of this interference remains unknown. Abstract: Background: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. Methods: This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6–14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (27 0/7 –36 6/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination. Results: 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5–77.1%) versus placebo (90.0–99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. Conclusions: Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. Clinical Trial Registration: ClinicalTrials.gov: NCT02422264.