Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women

Abstract

Tdap was well-tolerated in pregnant and nonpregnant women. Pregnant women were more likely to report moderate/severe pain at the Tdap injection-site compared with nonpregnant women, but did not necessitate medical visits. Prior Tdap receipt did not increase occurrence of moderate/severe local or systemic reactions in pregnant women. Serologic responses to all vaccine antigens were robust. Clinical Trial Registration@ClinicalTrials.gov. NCT02209623. https://clinicaltrials.gov/ct2/show/NCT02209623.

Safety of Maternal Immunization Against Pertussis: A Systematic Review

“…The most commonly reported reactions were injection site reactions, consistent with the Tdap label. While injection site reactions such as pain/tenderness, induration/swelling, itching, and erythema/redness were reported after Tdap/ Tdap-IPV administration in most clinical studies, pregnancy was not considered to have increased the rates of these events [13,34,[36][37][38]40]. However, moderate-to-severe injection site pain was more frequent in pregnant women than nonpregnant women in one study [34].…”

“…Fifteen studies reported vaccine reactogenicity among pregnant women following immunization with Tdap or Tdap-IPV, among which nine were prospective clinical trials [13,[34][35][36][37][38][39][40][41] and six were database analyses [42][43][44][45][46][47] (Table 1). The most commonly reported reactions were injection site reactions, consistent with the Tdap label.…”

“…While injection site reactions such as pain/tenderness, induration/swelling, itching, and erythema/redness were reported after Tdap/ Tdap-IPV administration in most clinical studies, pregnancy was not considered to have increased the rates of these events [13,34,[36][37][38]40]. However, moderate-to-severe injection site pain was more frequent in pregnant women than nonpregnant women in one study [34]. Injection site reactions assessed over 7 days were more common after Tdap than placebo in one small clinical study [13] but occurred at similar rates over 48 h in another slightly larger study [40].…”

Immunobiological aspects of vaccines in pregnancy: Maternal perspective

“…In one study, pregnant women given seasonal influenza vaccine had increased plasma levels of inflammatory cytokines during the first days after vaccination but these responses were similar to those in non-pregnant women [85]. In a recent study, pregnant women were more likely to report moderate and severe pain at the injection site following pertussis immunization as compared to non-pregnant women but the occurrence of other local and systemic reactions following vaccination was similar in both groups [93].…”

“…However, one of the two studies reported lower T cell responses to pertussis antigens in pregnant as compared to non-pregnant women [92]. A recent study involving a larger sample size observed lower antibody responses to pertussis toxin and filamentous hemagglutinin in pregnant as compared to non-pregnant women [93]. Factors responsible for the discordant results obtained in different studies are unclear but are possibly attributable to the relatively small size of the population included in most studies and to differences in tested vaccines and in participant characteristics, including pre-vaccination antibody titers that are an important determinant of vaccine responses [94].…”