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International Journal of Infectious... Jul 2020The Global Pertussis Initiative is an expert scientific forum that publishes consensus recommendations concerning pertussis for many regions of the world. Here, we give... (Review)
Review
The Global Pertussis Initiative is an expert scientific forum that publishes consensus recommendations concerning pertussis for many regions of the world. Here, we give recommendations for the primary vaccination of infants in those countries where whole-cell pertussis (wP)- and acellular pertussis (aP)-containing combination vaccines are used in parallel. A selective literature review was performed concerning the influence on safety, immunogenicity, and effectiveness of mixing wP- and aP-containing vaccines for primary immunization of infants. In addition, local data were collected from various countries and the results discussed in a face-to-face meeting. Very few data addressing issues of mixing combination vaccines were identified, and no data were available concerning the effectiveness or duration of protection. It was also found that pharmacovigilance data are scarce or lacking in those countries where they would be needed the most. We then identified frequent problems occurring in low- and middle-income countries (LMICs) where both vaccine types are used. Relying on local knowledge, we give practical recommendations for a variety of situations in different settings. Specific needs for additional data addressing these issues were also identified. International bodies, such as the World Health Organization (WHO), as well as vaccine producers should try to find ways to highlight the problems of mixing wP- and aP-containing combination vaccines with robust data. Countries are urged to improve on their pharmacovigilance for vaccines. For practicing physicians, our recommendations offer guidance when wP- and aP-containing vaccines are used in parallel during primary immunization.
Topics: Humans; Pertussis Vaccine; Poverty; Vaccination; Whooping Cough; World Health Organization
PubMed: 32413606
DOI: 10.1016/j.ijid.2020.04.081 -
Clinical Microbiology and Infection :... Dec 2016Pertussis is a highly contagious infectious disease caused by Bordetella pertussis that can be extremely serious, particularly in young infants. For many years the...
Pertussis is a highly contagious infectious disease caused by Bordetella pertussis that can be extremely serious, particularly in young infants. For many years the efforts of health authorities throughout the world to prevent pertussis had the main goals of reducing the morbidity of infants and children under 5 years of age, maintaining protection for several years during the school-age period and developing a significant herd immunity to directly and indirectly reduce the risk of the spread of the disease among young infants and the risk of transmission of the infection from preschool children to infants. However, the increased risk of B. pertussis infection among adolescents and adults due to the waning immunity to this bacterium induced by vaccines and natural infection seems to be the main reason for the resurgence of pertussis. We discuss the reasons for the administration of pertussis vaccines to individuals for whom they were previously not recommended, the expected results of the administration of additional pertussis vaccine doses and the differences in the administration of pertussis vaccines in different countries. An analysis of the literature revealed several reports indicating the need for the modification of immunization schedules against pertussis, with booster doses among adolescents and the need for the vaccination of pregnant women. However, to monitor the true epidemiology of pertussis, effective programmes to collect pertussis cases, adequate reporting systems and vaccination coverage monitoring should be urgently implemented.
Topics: Adolescent; Adult; Europe; Female; Humans; Immunization Schedule; Immunization, Secondary; Infant, Newborn; Pertussis Vaccine; Pregnancy; Whooping Cough
PubMed: 27130670
DOI: 10.1016/j.cmi.2016.01.003 -
Vaccine Jan 2017Though it is believed the switch from whole cell to acellular pertussis vaccine has contributed to the resurgence of pertussis disease, few studies have evaluated...
BACKGROUND
Though it is believed the switch from whole cell to acellular pertussis vaccine has contributed to the resurgence of pertussis disease, few studies have evaluated vaccine effectiveness (VE) and duration of protection provided by an acellular vaccine schedule including three primary doses but no toddler-age dose. We assessed this schedule in New Zealand (NZ), a setting with historically high rates of pertussis disease, and low but recently improved immunisation coverage. We further evaluated protection following the preschool-age booster dose.
METHODS
We performed a nested case-control study using national-level healthcare data. Hospitalised and non-hospitalised pertussis was detected among children 6weeks to 7years of age between January 2006 and December 2013. The NZ National Immunisation Register provided vaccination status for cases and controls. Conditional logistic regression was used to calculate dose-specific VE with duration of immunity examined by stratifying VE into ages aligned with the immunisation schedule.
RESULTS
VE against pertussis hospitalisation was 93% (95% confidence interval [CI]: 87, 96) following three doses among infants aged 5-11months who received three compared to zero doses. This protection was sustained through children's fourth birthdays (VE⩾91%). VE against non-hospitalised pertussis was also sustained after three doses, from 86% (95% CI: 80, 90) among 5-11month olds to 84% (95% CI: 80, 88) among 3-year-olds. Following the first booster dose at 4years of age, the protective VE of 93% (95% CI: 90, 95) among 4-year-olds continued through 7years of age (VE⩾91%).
CONCLUSIONS
We found a high level of protection with no reduction in VE following both the primary course and the first booster dose. These findings support a 3-dose primary course of acellular vaccine with no booster dose until 4years of age.
Topics: Age Factors; Case-Control Studies; Child; Child, Preschool; Female; Hospitalization; Humans; Infant; Male; New Zealand; Pertussis Vaccine; Treatment Outcome; Vaccines, Acellular; Whooping Cough
PubMed: 27866766
DOI: 10.1016/j.vaccine.2016.11.004 -
Human Vaccines & Immunotherapeutics 2014The United States switched from whole cell to acellular pertussis vaccines in the 1990s following global concerns with the safety of the whole cell vaccines. Despite... (Review)
Review
The United States switched from whole cell to acellular pertussis vaccines in the 1990s following global concerns with the safety of the whole cell vaccines. Despite high levels of acellular pertussis vaccine coverage, the United States and other countries are experiencing large pertussis outbreaks. The aim of this article is to describe the historical context which led to acellular pertussis vaccine development, focusing on vaccines currently licensed in the US, and to review evidence that waning protection following licensed acellular pertussis vaccines have been significant factors in the widespread reappearance of pertussis.
Topics: Communicable Diseases, Emerging; Disease Outbreaks; History, 20th Century; History, 21st Century; Humans; Pertussis Vaccine; United States; Vaccination; Vaccines, Acellular; Whooping Cough
PubMed: 25483496
DOI: 10.4161/hv.29576 -
Clinical Microbiology Reviews Jul 2008Pertussis, an acute respiratory infection caused by Bordetella pertussis, classically manifests as a protracted cough illness. The incidence of pertussis in the United... (Review)
Review
Pertussis, an acute respiratory infection caused by Bordetella pertussis, classically manifests as a protracted cough illness. The incidence of pertussis in the United States has been increasing in recent years. Immunity wanes after childhood vaccination, leaving adolescents and adults susceptible to infection. The transmission of pertussis in health care settings has important medical and economic consequences. Acellular pertussis booster vaccines are now available for use and have been recommended for all adolescents and adults. These vaccines are safe, immunogenic, and effective. Health care workers are a priority group for vaccination because of their increased risk of acquiring infection and the potential to transmit pertussis to high-risk patients. Health care worker vaccination programs are likely to be cost-effective, but further research is needed to determine the acceptability of pertussis vaccines among health care workers, the duration of immunity after booster doses, and the impact of vaccination on the management of pertussis exposures in health care settings.
Topics: Health Personnel; Humans; Pertussis Vaccine; Vaccination; Whooping Cough
PubMed: 18625679
DOI: 10.1128/CMR.00003-08 -
Trials Feb 2022The purpose of this double-blind, randomised, controlled trial is to compare allergic outcomes in children following vaccination with acellular pertussis (aP) antigen... (Randomized Controlled Trial)
Randomized Controlled Trial
Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule.
OBJECTIVE
The purpose of this double-blind, randomised, controlled trial is to compare allergic outcomes in children following vaccination with acellular pertussis (aP) antigen (standard of care in Australia) given at 2 months of age versus whole cell pertussis (wP) in the infant vaccine schedule.
PARTICIPANTS
Up to 3000 Australian infants 6 to <12 weeks of age born ≥32 weeks gestation.
INTERVENTIONS
The intervention is a wP containing vaccine as the first scheduled pertussis vaccine dose instead of an aP containing vaccine.
OUTCOMES
The primary outcome is a binary indicator of history of IgE-mediated food allergy at the age of 12 months confirmed, where necessary, with an oral food challenge before 18 months of age. Secondary outcomes include (1) history of parent-reported clinician-diagnosed new onset of atopic dermatitis by 6 or 12 months of age with a positive skin prick test to any allergen before 12 months of age, (2) geometric mean concentration in pertussis toxin-specific IgG before and 21 to 35 days after a booster dose of aP at 18 months of age, and (3) sensitisation to at least one allergen by 12 months of age.
RESULTS
Operating characteristics of trial decision rules were evaluated by trial simulation. The selected rules for success and futility approximately maintain type I error of 0.05 and achieved power 0.85 for a reduction in the primary outcome from 10% in the control group to 7% in the intervention group.
DISCUSSION
A detailed, prospective statistical analysis plan (SAP) is presented for this Bayesian adaptive design. The plan was written by the trial statistician and details the study design, pre-specified adaptive elements, decision thresholds, statistical methods, and the simulations used to evaluate the operating characteristics of the trial. Application of this SAP will minimise bias and supports transparent and reproducible research.
TRIAL REGISTRATION
Australia & New Zealand Clinical Trials Registry, ACTRN12617000065392 . Registered on 12 January 2017 STUDY PROTOCOL: https://doi.org/10.1136/bmjopen-2020-042838.
Topics: Antibodies, Bacterial; Australia; Bayes Theorem; Humans; Infant; Pertussis Vaccine; Prospective Studies; Vaccination
PubMed: 35130946
DOI: 10.1186/s13063-021-05874-6 -
Euro Surveillance : Bulletin Europeen... Oct 2014We reviewed the epidemiology of pertussis in Italy over the last 125 years to identify disease trends and factors that could have influenced these trends. We described... (Review)
Review
We reviewed the epidemiology of pertussis in Italy over the last 125 years to identify disease trends and factors that could have influenced these trends. We described mortality rates (1888-2012), case fatality rates (1925-2012), cumulative incidence rates (1925-2013) and age-specific incidence rates (1974-2013). We compared data from routine surveillance with data from a paediatric sentinel surveillance system to estimate under-notification. Pertussis mortality decreased from 42.5 per 100,000 population in 1890 to no reported pertussis-related death after 2002. Incidence decreased from 86.3 per 100,000 in 1927 to 1 per 100,000 after 2008. Vaccine coverage increased from 32.8% in 1993 to about 96% after 2006. As for under-notification, mean sentinel/routine surveillance incidence ratio increased with age (from 1.8 in <1 year-olds to 12.9 in 10-14 year-olds). Pertussis mortality decreased before the introduction of immunisation. Incidence has decreased only after the introduction of pertussis vaccine and in particular after the achievement of a high immunisation coverage with acellular vaccines. Routine surveillance does not show an increase in cumulative incidence nor in ≥ 15 year-olds as reported by other countries. Underrecognition because of atypical presentation and the infrequent use of laboratory tests may be responsible for under-notification, and therefore affect incidence reports and management of immunisation programmes.
Topics: Adolescent; Adult; Age Distribution; Aged; Bordetella pertussis; Child; Child, Preschool; Female; History, 19th Century; History, 20th Century; History, 21st Century; Humans; Immunization Programs; Incidence; Infant; Italy; Male; Middle Aged; Mortality; Pertussis Vaccine; Sentinel Surveillance; Whooping Cough
PubMed: 25323077
DOI: 10.2807/1560-7917.es2014.19.40.20921 -
Clinical and Experimental Immunology Jul 2019The maternal Tdap (tetanus, diphtheria and acellular pertussis) vaccination programme in the United Kingdom has successfully reduced cases of pertussis in young infants.... (Observational Study)
Observational Study
Antibody responses to Bordetella pertussis and other childhood vaccines in infants born to mothers who received pertussis vaccine in pregnancy - a prospective, observational cohort study from the United Kingdom.
The maternal Tdap (tetanus, diphtheria and acellular pertussis) vaccination programme in the United Kingdom has successfully reduced cases of pertussis in young infants. In addition to prevention of pertussis cases, it is also important to investigate the persistence of maternal antibodies during infancy and the possible interference of maternal antibodies with infant responses to vaccines. We recruited mother-infant pairs from vaccinated and unvaccinated pregnancies and measured concentrations of immunoglobulin (Ig)G against pertussis toxin (PTx), filamentous haemagglutinin (FHA), pertactin (Prn), diphtheria toxin (DTx), tetanus toxoid (TTx) Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae in mothers and infants at birth, and in infants at 7 weeks and at 5 months. Thirty-one mother-infant pairs were tested. Tdap-vaccinated women had significantly higher antibody against Tdap antigens, compared to unvaccinated women (DTx, P = 0·01; PTx, FHA, Prn and TTx, P < 0·001). All antibodies were actively transferred to the infants (transfer ratio > 1) with higher transfer of DTx (P = 0·04) and TTx (P = 0·02) antibody in Tdap-vaccinated pregnancies compared to unvaccinated pregnancies. Infants from Tdap-vaccinated pregnancies had significantly elevated antibodies to all antigens at birth (P < 0.001) and at 7 weeks (FHA, Prn, TTx, P < 0·001; DTx, P = 0.01; PTx, P = 0·004) compared to infants from unvaccinated pregnancies. Infants from Tdap-vaccinated and -unvaccinated pregnancies had comparable antibody concentrations following primary pertussis immunization (PTx, P = 0·77; FHA, P = 0·58; Prn, P = 0·60; DTx, P = 0·09; TTx, P = 0·88). These results support maternal immunization as a method of protecting vulnerable infants during their first weeks of life.
Topics: Antibodies, Bacterial; Antibody Specificity; Antigens, Bacterial; Bacterial Vaccines; Bordetella pertussis; Cohort Studies; Diphtheria-Tetanus-acellular Pertussis Vaccines; Female; Haemophilus influenzae type b; Humans; Immunity, Maternally-Acquired; Immunization Schedule; Immunization, Secondary; Infant; Infant, Newborn; Maternal-Fetal Exchange; Pertussis Vaccine; Pregnancy; Prospective Studies; Streptococcus pneumoniae
PubMed: 30758857
DOI: 10.1111/cei.13275 -
Revista Do Instituto de Medicina... 2009to discuss the current PAHO recommendation that does not support the substitution of traditional cellular DTP vaccine by acellular DTP, and the role of mutations, in... (Review)
Review
OBJECTIVE
to discuss the current PAHO recommendation that does not support the substitution of traditional cellular DTP vaccine by acellular DTP, and the role of mutations, in humans, as the main cause of rare adverse events, such as epileptic-like convulsions, triggered by pertussis vaccine.
DATA REVIEW
the main components related to toxic effects of cellular pertussis vaccines are the lipopolysaccharide of bacterial cell wall and pertussis toxin. The removal of part of lipopolysaccharide layer has allowed the creation of a safer cellular pertussis vaccine, with costs comparable to the traditional cellular vaccine, and which may be a substitute for the acellular vaccine.
CONCLUSION
The new methodology introduced by Instituto Butantan allows for the development of a new safer pertussis vaccine with low LPS content (Plow), and the use of the lipopolysaccharide obtained in the process in the production of monophosphoryl lipid A. This component has shown potent adjuvant effect when administered together with influenza inactivated vaccine, making possible to reduce the antigen dose, enhancing the production capacity and lowering costs.
Topics: Cost-Benefit Analysis; Diphtheria-Tetanus-Pertussis Vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines; Humans; Lipopolysaccharides; Mutation; World Health Organization
PubMed: 19551286
DOI: 10.1590/s0036-46652009000300002 -
Human Vaccines & Immunotherapeutics Dec 2024Pertussis is a vaccine-preventable infectious disease; however, data on pertussis antibody levels in a nationwide population are still limited in China. We aimed to pool... (Meta-Analysis)
Meta-Analysis Review
Pertussis is a vaccine-preventable infectious disease; however, data on pertussis antibody levels in a nationwide population are still limited in China. We aimed to pool the seropositivity rates of IgG antibodies against pertussis toxin (PT-IgG) across the country. We systematically searched PubMed, Web of Science, Embase, and the China National Knowledge Infrastructure Database for studies published between January 1, 2010, and June 30, 2023. Studies reporting the seroprevalence of PT-IgG among a healthy Chinese population were included. Pooled estimates were obtained using random-effects meta-analyzes. The meta-analysis included 39 studies (47,778 participants) reporting anti-PT IgG seropositivity rates. The pooled rate for all ages was 7.06% (95% CI, 5.50%-9.07%). Subgroup analyzes showed rates ranging from 6.36% to 12.50% across different age groups. This meta-analysis indicated a low anti-PT IgG seropositivity rate in the Chinese population, particularly among school-aged children and young adults. This finding underscores the urgent need to refine immunization strategies.
Topics: Humans; Seroepidemiologic Studies; Pertussis Toxin; Immunoglobulin G; Whooping Cough; China; Antibodies, Bacterial; Child; Adult; Young Adult; Adolescent; Child, Preschool; Middle Aged; Pertussis Vaccine; East Asian People
PubMed: 38695296
DOI: 10.1080/21645515.2024.2341454