Dataset Information

Factors Affecting the Implementation Process of Pertussis [Tdap] Immunization in Pregnant Women in an Italian Region: A Qualitative Study.

ABSTRACT: Whooping cough (pertussis) represents one of the most prevalent vaccine-preventable diseases in Western countries, capable of causing disease in infants, with a high risk of severe complications. To protect new-borns from pertussis, many countries have introduced the acellular pertussis adult vaccine in combination with tetanus and diphtheria toxoids for women in the third trimester of pregnancy. Thanks to the approval of the new National Immunization Prevention Plan 2017-2019: Italy is among those countries. The Italian health-care system is a regionally based National Health Service, therefore, regions organize and implement new vaccination strategy on their own. This study focuses on Tuscany's experience in implementing the maternal pertussis vaccination. The present study had a qualitative design: we obtained information about the implementation process through interviews with relevant stakeholders involved in the planning or implementation of vaccination programme at different levels. We noticed heterogeneous implementation's status between Tuscan Health Care Departments. The most frequently reported barriers influencing the success of the implementation process of this prevention strategy included: lack of accountability, lack of enabling instruments, financial constraints, logistics barriers, training deficiencies, attitudes of health care workers, and lack of communication experts. The implementation of new vaccination programs is complex and challenging. Often the importance of education and information activities targeting health professionals are underestimated and underfunded. These elements would need to be carefully considered and adequate provisions should be made to address them when designing and implementing effective vaccine interventions.

SUBMITTER: Mazzilli S

PROVIDER: S-EPMC7212430 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Factors Affecting the Implementation Process of Pertussis [Tdap] Immunization in Pregnant Women in an Italian Region: A Qualitative Study.

Mazzilli Sara S Tavoschi Lara L Lopalco Pier Luigi PL

Frontiers in public health 20200422

Whooping cough (pertussis) represents one of the most prevalent vaccine-preventable diseases in Western countries, capable of causing disease in infants, with a high risk of severe complications. To protect new-borns from pertussis, many countries have introduced the acellular pertussis adult vaccine in combination with tetanus and diphtheria toxoids for women in the third trimester of pregnancy. Thanks to the approval of the new National Immunization Prevention Plan 2017-2019: Italy is among th ...[more]

PMID: 32426313

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Project description:ImportanceImmunization with tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in the United States during weeks 27 through 36 of pregnancy to prevent life-threatening infant pertussis. The optimal gestation for immunization to maximize concentrations of neonatal pertussis toxin antibodies is unknown.ObjectiveTo determine pertussis toxin antibody concentrations in cord blood from neonates born to women immunized and unimmunized with Tdap vaccine in pregnancy and optimal gestational age for immunization to maximize concentrations of neonatal antibodies.Design, setting, and participantsProspective, observational, cohort study of term neonates in Houston, Texas (December 2013-March 2014).ExposuresTdap immunization during weeks 27 through 36 of pregnancy or no Tdap immunization.Main outcomes and measuresPrimary outcome was geometric mean concentrations (GMCs) of pertussis toxin antibodies in cord blood of Tdap-exposed and Tdap-unexposed neonates and proportions of Tdap-exposed and Tdap-unexposed neonates with pertussis toxin antibody concentrations of 15 IU/mL or higher, 30 IU/mL or higher, and 40 IU/mL or higher, cutoffs representing quantifiable antibodies or levels that may be protective until the infant immunization series begins. Secondary outcome was the optimal gestation for immunization to achieve maximum pertussis toxin antibodies.ResultsSix hundred twenty-six pregnancies (mean maternal age, 29.7 years; 41% white, 27% Hispanic, 26% black, 5% Asian, 1% other; mean gestation, 39.4 weeks) were included. Three hundred twelve women received Tdap vaccine at a mean gestation of 31.2 weeks (range, 27.3-36.4); 314 were unimmunized. GMC of neonatal cord pertussis toxin antibodies from the Tdap-exposed group was 47.3 IU/mL (95% CI, 42.1-53.2) compared with 12.9 IU/mL (95% CI, 11.7-14.3) in the Tdap-unexposed group, for a GMC ratio of 3.6 (95% CI, 3.1-4.2; P?<?.001). More Tdap-exposed than Tdap-unexposed neonates had pertussis toxin antibody concentrations of 15 IU/mL or higher (86% vs 37%; difference, 49% [95% CI, 42%-55%]), 30 IU/mL or higher (72% vs 17%; difference, 55% [95% CI, 49%-61%]), and 40 IU/mL or higher (59% vs 12%; difference, 47% [95% CI, 41%-54%]); P?<?.001 for each analysis. GMCs of pertussis toxin antibodies were highest when Tdap vaccine was administered during weeks 27 through 30 and declined thereafter, reaching a peak at week 30 (57.3 IU/mL [95% CI, 44.0-74.6]).Conclusions and relevanceImmunization with Tdap vaccine during the third trimester of pregnancy, compared with no immunization, was associated with higher neonatal concentrations of pertussis toxin antibodies. Immunization early in the third trimester was associated with the highest concentrations.

Project description:ObjectiveTetanus toxoid, reduced diphtheria toxoid, and acellular pertusiss (Tdap) vaccine is recommended during each pregnancy, regardless of prior receipt. Data on reactogenicity and immunogenicity, particularly after repeated Tdap, are limited. We compared local injection-site and systemic reactions and serologic response following Tdap in (1) pregnant and nonpregnant women and (2) pregnant women by self-reported prior Tdap receipt.Study designPregnant women (gestational age 20-34 weeks) and nonpregnant women receiving Tdap were enrolled in this observational study. Injection-site and systemic reactions were assessed for one week post-vaccination. Pertussis toxin, filamentous hemagglutinin, pertactin, fimbriae, tetanus and diphtheria specific IgG antibody titers were determined by standardized enzyme-linked immunosorbent assay at baseline and 28 days post-vaccination. Reactogenicity and serologic responses were compared by pregnancy status, and within pregnant women by self-reported prior Tdap receipt.Results374 pregnant and 225 nonpregnant women were vaccinated. Severe local or systemic reactions or "any" fever were uncommon (≤3% for both groups). Moderate/severe injection-site pain was significantly higher in pregnant (17.9%) versus nonpregnant (11.1%) women, but did not prompt a healthcare visit. Proportions of other moderate/severe or any severe reactions were not significantly higher in pregnant compared to nonpregnant women. Moderate/severe (including pain) and severe reactions were not significantly higher in pregnant women receiving repeat versus first-time Tdap. Antibody titers increased from baseline to post-vaccination for all vaccine antigens in pregnant and nonpregnant women; post-vaccination titers against pertussis toxin and filamentous hemagglutinin were significantly higher in nonpregnant versus pregnant women (p < 0.01).ConclusionTdap 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.

Project description:BackgroundThis study aimed to assess whether Italian healthcare workers (HCWs) recommend the reduced antigen content tetanus-diphtheria-acellular pertussis vaccination (Tdap) to pregnant people, as well as what variables could predict their decision to advise and recommend immunization to pregnant people.MethodsThis cross-sectional study took place between August 2021 and June 2022 in a sample of obstetricians-gynecologists, midwives, and primary-care physicians in two regions of Southern Italy. A self-administered questionnaire was used to gather the data.ResultsThe results showed 91.3% (379) of participants knew that receiving the Tdap vaccine during pregnancy protects against pertussis in both the expectant person and the newborn before active immunization. Only 68.9% (286) knew that the Tdap vaccination has to be administered during the third trimester of gestation. A small but still significant proportion of participants (14.7%) (61) believed that the potential risks of vaccines administered during pregnancy outweighed the benefits. An improvable proportion of HCWs regularly provided information [71.8% (298)] and recommended [81% (336)] Tdap vaccination to pregnant people. The strongest factors that drove HCWs to inform pregnant people about the Tdap vaccination were to be aware that vaccinating those in close contact with newborns is an effective strategy to prevent pertussis (OR: 2.38; 95% CI: 1.11-5.13) and that the Tdap vaccine is provided only in the third trimester of pregnancy (OR: 1.74; 95% CI: 1.06-2.86). Informing pregnant people about the possibility of receiving the Tdap vaccine during pregnancy (OR: 60.13; 95% CI: 23.50-153.8) was the strongest predictor of having recommended the Tdap vaccination during pregnancy.ConclusionEducational and informative interventions to improve HCWs' knowledge about the importance of the Tdap vaccine and their communication skills to properly counsel pregnant people are needed. Beyond vaccine recommendations, how well immunization strategies are implemented in real-world situations impacts vaccination uptake. Therefore, during regular care visits, expecting people must have easy access to vaccines. Prenatal immunizations should become common practice, and there should be no conceptual doubt about vaccinations among HCWs to safeguard pregnant people and their unborn children from vaccine-preventable diseases.

Project description:ImportanceMaternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis.ObjectiveTo evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.Design, setting, and participantsPhase 1-2, randomized, double-blind, placebo-controlled, clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum.InterventionsTdap vaccination at 30 to 32 weeks' gestation or postpartum.Main outcomes and measuresPrimary outcomes were maternal and infant adverse events, pertussis illness, and infant growth and development until age 13 months. Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months' postpartum, and in infants at birth, at 2 months, and after the third and fourth doses of DTaP.ResultsNo Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 26 (78.8% [95% CI, 61.1%-91.0%]) and 12 (80% [95% CI, 51.9%-95.7%]) pregnant and postpartum women, respectively (P > .99). Systemic symptoms were reported in 12 (36.4% [ 95% CI, 20.4%-54.9%]) and 11 (73.3% [95% CI, 44.9%-92.2%]) pregnant and postpartum women, respectively (P = .03). Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum (eg, pertussis toxin antibodies: 51.0 EU/mL [95% CI, 37.1-70.1] and 9.1 EU/mL [95% CI, 4.6-17.8], respectively; P < .001) and in their infants at birth (68.8 EU/mL [95% CI, 52.1-90.8] and 14.0 EU/mL [95% CI, 7.3-26.9], respectively; P < .001) and at age 2 months (20.6 EU/mL [95% CI, 14.4-29.6] and 5.3 EU/mL [95% CI, 3.0-9.4], respectively; P < .001). Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP.Conclusions and relevanceThis preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants. For secondary outcomes, maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy.Trial registrationclinicaltrials.gov Identifier: NCT00707148.

Project description:Many countries recommend combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis immunization (Tdap) during pregnancy to stimulate transplacental transmission of pertussis antibodies to newborns. The immune system can be altered during pregnancy, potentially resulting in differing immunization risks in pregnant women. The safety of widespread Tdap immunization during pregnancy needs to be established. Our objective was to assess whether prenatal Tdap immunization was associated with adverse birth outcomes, and to evaluate the effect of timing of Tdap administration on these outcomes. We identified pregnancies at delivery in a large insurance claims database (2010-2014). Tdap immunization was categorized as optimal prenatal (27+weeks), early prenatal (<27weeks), postpartum (?7days post-delivery), or none. Medical claims were searched to identify maternal adverse immunization reactions (e.g. anaphylaxis, fever, Guillian-Barre syndrome [GBS]), adverse birth outcomes (e.g. preeclampsia/eclampsia, premature rupture or membranes, chorioamnionitis) and newborn outcomes (e.g. respiratory distress, pulmonary hypertension, neonatal jaundice). Women with optimal or early prenatal Tdap were compared to those not immunized in pregnancy, using propensity score-weighted log-binomial regression and Cox proportional hazards models to estimate risk ratios (RR) and hazard ratios (HR). We identified 1,079,034 deliveries and 677,075 linked newborns; 11.5% were immunized optimally and 2.3% immunized early. There were 1 case of post-immunization anaphylaxis, and 12 cases of maternal encephalopathy (all post- delivery); there were no cases of GBS. Optimally-timed immunization was associated with small increased relative risks of: chorioamnionitis [RR=1.11, (95% CI: 1.07-1.15), overall risk=2.8%], and postpartum hemorrhage [RR=1.23 (95% DI: 1.18-1.28), overall risk=2.4%]; however, these relative increases corresponded to low absolute risk increases. Tdap was not associated with increased risk of any adverse newborn outcome. Overall, prenatal Tdap immunization was not associated with newborn adverse events, but potential associations with chorioamnionitis consistent with one previous study and postpartum hemorrhage require further investigation.

Dataset Information

Factors Affecting the Implementation Process of Pertussis [Tdap] Immunization in Pregnant Women in an Italian Region: A Qualitative Study.

Publications

Factors Affecting the Implementation Process of Pertussis [Tdap] Immunization in Pregnant Women in an Italian Region: A Qualitative Study.

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