Safety Of Pertussis Vaccine Research Articles

Safety of pertussis vaccines for adolescents

Aim: to investigate the safety of acellular pertussis vaccines for adolescents.Materials and methods. The clinical tolerability of revaccination against pertussis (cell-free component), diphtheria and tetanus was analyzed in 107 children aged 13,5–14 years. Group 1 consisted of children revaccinated with DTacP-IPV combined vaccine (Tetraxim), group 2 – vaccinated with Td and group 3 – children who received Tdap vaccine (Adacel).Results. Statistically significant differences in the frequency of local reactions between the group that received Tdap and the other two (DTacP-IPV and Td) were detected (p = 0.001and p = 0.04, respectively). Analysis of the structure of local reactions revealed a difference only in the occurrence of the hyperemia at the site of injection, with the most frequent registration in the groups of children vaccinated with DTacPIPV (29,4%) and Td (14,7%), whereas in patients vaccinated with Tdap – only in 5,9% (χ2 = 6,8 p = 0,03). Systemic reactions occurred with the same frequency in all studied groups and did not require medical correction, as well as local reactions. Thus, revaccination against pertussis, diphtheria and tetanus of adolescents using Tdap, containing the acellular pertussis component, does not exceed the frequency of systemic reactions and the number of local reactions is significantly lower in comparison with the vaccine with a reduced content of diphtheria and tetanus toxoids (Td) that is used in practice for a long time.

Efficacy and safety of pertussis vaccination in pregnancy to prevent whooping cough in early infancy

Efficacy and safety of pertussis vaccination in pregnancy to prevent whooping cough in early infancy

Efficacy and safety of pertussis vaccination for pregnant women \u2013 a systematic review of randomised controlled trials and observational studies

BackgroundWorldwide, pertussis remains a major health problem among children. During the recent outbreaks of pertussis, maternal antenatal immunisation was introduced in several industrial countries. This systematic review aimed to synthesize evidence for the efficacy and safety of the pertussis vaccination that was given to pregnant women to protect infants from pertussis infection.MethodsWe searched literature in the Cochrane Central Register of Controlled Trials, Medline, Embase, and OpenGrey between inception of the various databases and 16 May 2016. The search terms included ‘pertussis’, ‘whooping cough’, ‘pertussis vaccine,’ ‘tetanus, diphtheria and pertussis vaccines’ and ‘pregnancy’ and ‘perinatal’.ResultsWe included 15 articles in this review, which represented 12 study populations, involving a total of 203,835 mother-infant pairs from the US, the UK, Belgium, Israel, and Vietnam. Of the included studies, there were two randomised controlled trials (RCTs) and the rest were observational studies. Existing evidence suggests that vaccinations administered during 19–37 weeks of gestation are associated with significantly increased antibody levels in the blood of both mothers and their newborns at birth compared to placebo or no vaccination. However, there is a lack of robust evidence to suggest whether these increased antibodies can also reduce the incidence of pertussis (one RCT, n = 48, no incidence in either group) and pertussis-related severe complications (one observational study) or mortality (no study) in infants. Meanwhile, there is no evidence of increased risk of serious complications such as stillbirth (e.g. one RCT, n = 103, RR = 0, meaning no case in the vaccine group), or preterm birth (two RCTs, n = 151, RR = 0.86, 95%CI: 0.14–5.21) related to administration of the vaccine during pregnancy.ConclusionGiven that pertussis infection is increasing in many countries and that newborn babies are at greatest risk of developing severe complications from pertussis, maternal vaccination in the later stages of pregnancy should continue to be supported while further research should fill knowledge gaps and strengthen evidence of its efficacy and safety.

Vaccine attitudes and practices among obstetric providers in New York State following the recommendation for pertussis vaccination during pregnancy

To determine factors associated with obstetric provider recommendation of pertussis vaccine (Tdap) to their pregnant patients following the Advisory Committee on Immunization Practices (ACIP) recommendation that Tdap be given in the third trimester of each pregnancy. Obstetric providers across New York State anonymously completed a standard set of questions to assess vaccine recommendation knowledge and practice. Statistical analysis: Descriptive statistical methods were used to define provider characteristics, knowledge and vaccine practices. Factors associated with recommendation were analyzed using odds ratios. 133 obstetric providers were included in the study. 11% and 13% expressed concern with pertussis vaccine safety and efficacy, respectively, in pregnant women. 92% of obstetric providers stated that they knew ACIP recommendations for Tdap during pregnancy, 80% recommended Tdap to all eligible patients, but only 67% provided Tdap vaccine in their office. Provider knowledge of recommendation (OR 23.33), routine provider recommendation of influenza vaccine (OR 12.5), and administration of pertussis vaccine in the office (OR 7.01) were all factors strongly associated with routine provider recommendation of Tdap vaccine to eligible pregnant women (P < 0.05). Providers expressed concerns with cost of Tdap, the need to administer Tdap with each pregnancy, vaccine safety, low incidence of pertussis in the area, and administration of pertussis vaccine at the hospital after delivery. Educational programs are needed to improve provider vaccine confidence and recommendation.

Pertussis Booster Vaccination in Pregnancy: Women Who had it Compared to Those Who Waited

BackgroundGuidelines for protecting young infants from pertussis now recommend maternal pertussis booster vaccination (dTpa) during pregnancy (3rd trimester) over postpartum maternal vaccination. MethodsWe undertook a cross-sectional survey of 723 postpartum women on the postnatal ward of a private hospital in Sydney, Australia. We excluded 47% of women who were ‘up to date’ with their pertussis booster prior to pregnancy. We surveyed the remaining 53% of women who were eligible for the pertussis booster vaccine during their pregnancy (no dTpa<5years). ResultsIn our study, pertussis booster vaccine uptake during pregnancy was only 8.7%. We confirmed that vaccination mostly occurred at the family doctor's practice (25/33; 75.8%), at an average of 34 weeks gestation (±5wks). Women vaccinated during pregnancy were more likely to report that they received a pregnancy-specific pertussis vaccine recommendation (<0.001), and had no vaccine safety concerns (0.004) or transport difficulties in accessing an immunization provider (0.032). They also had twice the odds of receiving an influenza vaccine during pregnancy (0.002). Additionally, 70% of vaccinated women reported that their partner had also been recently vaccinated against pertussis. Amongst unvaccinated women we found that 80% intended to be vaccinated, yet 33% would only do so if the vaccine was free (publically funded). Additionally, 40% of unvaccinated women would have agreed to pertussis vaccination during pregnancy had their doctor recommended it. ConclusionProviders should highlight pertussis vaccine safety and recommend vaccination during late pregnancy.

Safety of Pertussis Vaccination During Pregnancy

The rising incidence of pertussis (including fatal cases in neonates) in 2011 led to recommendations by the CDC's Advisory Committee on Immunization

Safety of pertussis vaccination in pregnant women in UK: observational study

Objective To examine the safety of pertussis vaccination in pregnancy.Design Observational cohort study.Setting The UK Clinical Practice Research Datalink.Participants 20 074 pregnant women with a median age of 30 who...

Modified binding assay for improved sensitivity and specificity in the detection of residual pertussis toxin in vaccine preparations

A binding assay was recently published that differentiates between pertussis toxin (PTx) and the pertussis toxoid (PTd) used in acellular pertussis vaccines based on the selective binding of PTx to fetuin and detection with a polyclonal antibody. We found that the assay specificity for PTx was affected by both pH and salt. A monoclonal antibody (mAb) was identified that eliminated specificity problems and improved the sensitivity to 0.4 ng PTx/ml. This mAb was previously shown to neutralize PTx toxicity in vivo, thereby supporting the assay's potential biological relevance as an alternative to the mouse histamine sensitivity test for the safety of pertussis vaccines.

Application of quantitative gene expression analysis for pertussis vaccine safety control

Although vaccines are routinely used to prevent infectious diseases, little is known about the comprehensive influences caused by vaccines. In this study, we showed, using comprehensive gene expression analysis, that pertussis vaccine affected many genes in multiple organs of vaccine-treated animals. In particular, lung was revealed to be the most suitable target to evaluate pertussis vaccine toxicity. The 13 genes identified from the analysis of vaccine-treated lung at day 1 showed a clear dendrogram corresponding to pertussis vaccine toxicity. Furthermore, quantitative analysis of these genes revealed a positive correlation between their respective expression levels and the degree of toxic effects observed in samples that had been treated with various doses of reference pertussis vaccines. The quantification of this 13 gene-set is an indicator of the vaccine toxicity-related reaction.

Two vaccine toxicity-related genes Agp and Hpx could prove useful for pertussis vaccine safety control

Conventional animal tests such as leukocytosis promoting tests have been used for decades to evaluate toxicity of pertussis vaccine. Here, we examined gene expression in relation to the vaccine toxicity using a DNA microarray. Comparison of conventional animal test data with the DNA microarray-based gene expression data revealed a gene expression pattern highly correlated with leukocytosis in animals. Of 10,490 rat genes analyzed, two genes, α1-acid-glycoprotein (Agp) and hemopexin (Hpx), were found up-regulated by the toxin administration in a dose-dependent manner (assayed by a quantitative PCR based on the microarray). Variation of the gene expression was very small amongst the test animals, and the results were highly reproducible. These findings suggest that gene expression analysis of vaccine-treated animals can be used as an accurate and simple method of pertussis vaccine safety assessment.

Economic Considerations for Pertussis Booster Vaccination in Adolescents

Despite good acellular pertussis vaccine safety and protective efficacy, as well as high vaccination rates among young children, the incidence of pertussis in the United States has steadily increased since the 1980s. This is especially true for adolescents and adults who are susceptible because of waning immunity, which is not long lived. Other populations are at increased risk for morbidity of infection, although infants younger than 6 months of age who have not completed the primary immunization series have the greatest morbidity and mortality. Other groups who might benefit from booster immunizations include hospital workers, family contacts, and individuals with compromised health. Although older individuals generally have milder illnesses, they are often the source of infection for younger children. An adolescent/adult formulation of acellular pertussis vaccine requires a lower dose of pertussis antigens and can be combined with currently recommended diphtheria and tetanus toxoids (Tdap). These new vaccines for adolescents and adults are safe, immunogenic, and protective. Through an extensive review of the literature, the direct and indirect costs associated with pertussis and its complications are examined, cost-benefit analyses of pertussis booster vaccination are evaluated for different groups, and the economic considerations involved in implementing a pertussis booster vaccination program in adolescents are discussed. Pertussis infections cause outbreaks in schools, families, and workplaces, resulting in prolonged morbidity and significant costs for medical care, lost time, and wages. Physician visits, chest radiographs, and antibiotics comprise the majority of direct costs, and costs associated with work loss often comprise the majority of indirect costs related to pertussis illness. Adolescents and adults also transmit their infections to nonimmune children. A cost-benefit analysis evaluated the health and economic benefits of seven strategies for administering a pertussis booster. The most economical strategy is to immunize all adolescents 10-19 years of age, which may prevent 0.4-1.8 million cases of pertussis and save US 0.3-1.6 billion dollars in a decade. A tetanus and diphtheria booster (Td) is currently recommended for children 11-12 years of age. The Tdap vaccine offers an enhancement for the Td booster by providing protection against pertussis, and it will not require an additional injection or office visit. Immunizing adolescents with a pertussis booster in the form of Tdap is the most economical and easiest-to-implement strategy and should provide significant health and economic benefits.

Acellular Pertussis Vaccine Safety and Efficacy in Children, Adolescents and Adults

This review offers a perspective on the acellular pertussis vaccine efficiency trials concluded in the 1990s and presents the main conclusions of a meta-analysis of 52 studies that assessed the safety and efficacy of the diphtheria-tetanus (DT)-whole cell pertussis (DTwP) and DT-acellular pertussis (DTaP) vaccines administered to children. A clear serological correlate of immunity to pertussis following DTaP vaccination was not identified despite an intensive analysis. It can be speculated that this may be because various combinations of antibody to agglutinogens (pertussis toxin, filamentous haemagglutinin, pertactin and fimbriae) provide protection, or because serum antibody levels and responses do not uniformly reflect mucosal IgA antibody levels.Long-term efficacy following DTaP vaccination is becoming characterised and cell-mediated immunity (T-cell memory) may have importance. DTaP vaccination appears to establish herd immunity after sufficient uptake within communities and countries. As experience with DTaP vaccine safety has accumulated, a 1-2% occurrence of large, local injection reactions with all products has been defined for booster doses. The pathophysiological mechanisms for the reactions are not established but a majority appear likely to be IgE-mediated reactive oedema and a minority to be IgG-mediated reactive Arthus-type reactions. DTwP and DTaP combinations with other vaccines have been studied and licensed; the most controversial combination products are the DTaP/Haemophilus influenzae type B polysaccharide conjugate vaccines. Pertussis epidemiology is changing with a clear increase in occurrence in adolescents and adults. This development has spurred studies and licensure of safer DTaP vaccines for this older population. The economic impact of pertussis and transmission from adults to vulnerable infants provides a cost-benefit justification for widespread use of DTaP vaccines in all age groups with routine boosting every 10 years.

Systematic review of the effects of pertussis vaccines in children

Objective: To assess the efficacy and safety of whole-cell and acellular pertussis vaccines administered to children singly or within diphtheria, tetanus and pertussis (DTP) vaccines. Data sources: We searched the Cochrane Library, MEDLINE, EMBASE, Biological Abstracts and Science Citation Index to December 2001. Specialised websites and bibliographies of retrieved articles and reviews were assessed. Vaccine manufacturers and investigators were contacted for additional data. Review methods: We included randomised and cohort studies comparing efficacy and/or safety of pertussis vaccines with placebo, DT, no intervention or each other. Results: We included 52 studies (49 randomised controlled trials (RCTs), 3 cohort studies). All tested whole-cell and acellular vaccines were significantly more effective than placebo against pertussis. Absolute efficacy of whole-cell DTP varied from 37 to 92%. One- and two-component acellular vaccines had lower absolute efficacy (67–70%), than vaccines with ≥3 components (80–84%). Whole-cell vaccines were associated with significantly higher incidences of swelling and induration (odds ratio (OR) 11.67, 95% confidence interval (CI) 8.83–15.44), fever (OR for fever >39 °C 3.36, 95% CI 2.06–5.49) and crying for >2 h (OR 4.72, 95% CI 2.94–7.59) than placebo or DT. Differences in incidence of hypotonic hyporesponsive episodes (HHE) and convulsions were not statistically significant. Acellular pertussis vaccines did not cause a higher incidence of local signs, fever, convulsions, HHE or prolonged crying than placebo or DT. Conclusion: All tested pertussis vaccines were efficacious. Whole-cell vaccines show variable efficacy, making interpretation of direct comparisons unreliable. Acellular vaccines with ≥3 antigenic components showed higher efficacy than one- and two-component vaccines. The adverse event profile of acellular vaccines was similar to that of placebo and considerably better than that of whole-cell vaccines.

Adverse Events Associated With Childhood Vaccines: Evidence Bearing on Causality

This volume attempts to answer many of the questions asked by pediatricians, as well as their patients, about immunization practices. A very simple statement of fact begins the report: Childhood immunization has been one of the foremost public health measures of the twentieth century. It has allowed control and prevention of many diseases from which morbidity and mortality can be staggering. The next paragraph introduces the issue, "The public policy debate regarding immunization stretches beyond the question of how to meet the goals of universal immunization," to the question of safety of pertussis vaccine and other vaccines, the media publicity attendant on the concerns, and the many groups of "interested citizens." The 1986<i>National Childhood Vaccine Injury Act e</i>stablished the compensation program and the reporting system and also required the Institute of Medicine of the National Academy of Sciences to study the adverse effects via two specific studies: the

Attitudes of Victorian vaccine providers to pertussis vaccine.

To assess the attitudes of Victorian vaccine providers to the pertussis component of the diphtheria-tetanus-pertussis vaccine (DTP), and to examine differences between kinds of health professionals. Also, to assess vaccine providers' understanding of National Health and Medical Research Council (NHMRC) guidelines on childhood immunisation with DTP. We conducted a postal survey of 765 randomly selected Victorian health professionals involved in childhood vaccination, including medical officers of health (MOHs), general practitioners (GPs), maternal child health nurses (MCHNs), paediatricians and environmental health officers (EHOs). Most (83%) knew that the pertussis component was most frequently responsible for adverse effects of DTP. Thirty-four per cent of all respondents (9% MCHNs, 23% paediatricians, 24% MOHs, 34% EHOs and 39% GPs) believed that pertussis vaccine causes permanent brain damage, 34% did not, and 32% were unsure; 39% believed it causes encephalopathy. Only 9% described vaccination practices entirely in accordance with NHMRC guidelines. Up to 58% of respondents would give diphtheria-tetanus vaccine (DT) in situations when DTP was indicated, and up to 54% would give DTP when it is clearly contraindicated. There was no correlation between knowledge of the safety of DTP and vaccination practices. Victorian vaccine providers have doubts about the safety of pertussis vaccine. There is a need to ensure the availability and clarity of immunisation guidelines for health workers, to educate them about the use of pertussis vaccine, and to ensure that this knowledge is put into practice.

Reassurance on safety of pertussis vaccines

Reassurance on safety of pertussis vaccines

Immunization Practices in Children

The resurgence of measles has highlighted concerns about U.S. programs for immunization in infants and children. In order to put the problems into perspective, this review will address such issues as the safety of pertussis vaccines; oral vs inactivated poliovirus vaccine; vaccines for measles-mumps-rubella, Hemophilus influenzae type B, and hepatitis B; and varicella vaccine.

Safety of pertussis vaccine

Safety of pertussis vaccine

Diphtheria, Tetanus, and Pertussis Immunizations in Adults

Although only few cases of diphtheria are reported annually in the United States, substantial numbers of adults have declining levels of protective serum antitoxin. A recent outbreak of diphtheria in Sweden emphasizes the importance of reimmunizing adults in diphtheria toxoid, included as part of routine use of tetanus/diphtheria toxoid. Tetanus is a completely preventable disease. Yet, most of the 60 to 100 annual cases of tetanus occur in older adults with no prior history of immunization. Tetanus immunization should be a routine part of medical care of all adults. Research currently is aimed at improving the efficacy and safety of pertussis vaccine. Future vaccines may be useful in protecting health care workers and other adults who have extensive contact with children against pertussis.

New Thoughts on Pertussis

The success of initial pertussis immunization programs resulted not only in a sharp decrease in the incidence of the disease but also in a diminution of interest in and research on the organism, and complacency with regard to the vaccine itself. Concern and apprehension about both the efficacy and the safety of pertussis vaccine have recently stimulated a renewed investigative interest in the biology of Bordetella pertussis. This occurs at a time. when cases of pertussis reported in the United States are at an all-time low (less than 2,000 in 1978 contrasted with more than 150,000 in 1950). This infrequency of clinical whooping cough contributes to our desire for a more critical examination of the rare serious complications attributed to the immunizing procedure.