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Vaccine Jul 2023The spleen is responsible for blood filtration and mounting an immune response against pathogens. In some people the spleen must be surgically removed because of...
The spleen is responsible for blood filtration and mounting an immune response against pathogens. In some people the spleen must be surgically removed because of traumatic events or oncological and hematological conditions. These patients are at higher risk of developing diseases caused by encapsulated bacteria throughout their lives. Thus, immunisations are advised for splenectomised persons to prevent infection caused by Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b (Hib). This study assessed vaccination coverage (VC) among Norwegian patients with surgical asplenia. Using the Nomesco Classification of Surgical Procedures codes, patient information (age, sex, date of initial diagnosis and date of surgery) was acquired from the Norwegian Patient Registry. The National Immunization Register provided information on vaccination status and data of any subsequent invasive bacterial infections were obtained from the Norwegian Surveillance System for Communicable Diseases. From the total population of Norway, 3155 patients who had undergone complete splenectomy were identified. Of these, 914 (29.0%) had received at least one dose of pneumococcal conjugate vaccine (PCV), 1324 (42.0%) at least one dose of pneumococcal polysaccharide vaccine and 589 (18.7%) had received both. Only 4.2% of the patients had received two doses of a meningococcal ACWY conjugate vaccine, while 8.0% of 1467 patients splenectomised after 2014 had received at least two doses of a serogroup B meningococcal vaccine. The VC for Hib was 18.7%. Nearly all splenectomised children under the age of 10 were vaccinated with Hib and PCV as these vaccines are included in the childhood immunisation program. For all vaccines, VC decreased with age. Twenty-nine invasive bacterial infections were registered post-splenectomy in 25 patients. Vaccination according to national recommendations could have prevented at least 8 (28%) of these infections. Our study showed that efforts are required to increase VC of splenectomised individuals in Norway.
Topics: Child; Humans; Bacterial Infections; Haemophilus influenzae type b; Haemophilus Vaccines; Meningococcal Vaccines; Norway; Pneumococcal Vaccines; Splenectomy; Vaccination; Vaccines, Conjugate; Guideline Adherence; Vaccination Coverage
PubMed: 37336662
DOI: 10.1016/j.vaccine.2023.06.034 -
Human Vaccines & Immunotherapeutics Aug 2023Affordable, polyvalent meningococcal vaccines are needed for use in emergency reactive immunization campaigns. A phase IV randomized, observer-blind, controlled study... (Randomized Controlled Trial)
Randomized Controlled Trial
Safety and immunogenicity of quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with quadrivalent meningococcal conjugate vaccine (Menactra®) in Malian children.
Affordable, polyvalent meningococcal vaccines are needed for use in emergency reactive immunization campaigns. A phase IV randomized, observer-blind, controlled study compared the safety and immunogenicity of a quadrivalent meningococcal polysaccharide vaccine (MPV-4, MPV ACYW135) and quadrivalent meningococcal ACWY conjugate vaccine (MCV-4, Menactra®). Healthy, 2- to 10-year-old children in Bamako, Mali, were randomized 1:1 to receive one dose of MPV-4 or MCV-4. Safety outcomes were evaluated for 6 months post-immunization. Immunogenicity for all serogroups was assessed for non-inferiority between MPV-4 and MCV-4 30 days post immunization by serum bactericidal antibody assay using baby rabbit complement (rSBA). From December 2020 to July 2021, 260 healthy subjects were consented and randomized. At Day 30 post-immunization, the proportions of subjects with rSBA titers ≥ 128 for all serogroups in the MPV-4 group were non-inferior to those in MCV-4 group. The proportions of subjects with rSBA ≥ 4-fold increase and rSBA titers ≥ 8 for all serogroups were similar among vaccine groups ( > .05). Geometric Mean Titers and Geometric Mean Fold Increases for all serogroups in both vaccine groups were similar ( > .05). Few local and systemic post-immunization reactions of similar severity and duration were observed within 7 days and were similar in both groups ( > .05). All resolved without sequelae. Unsolicited adverse events were similar in both groups regarding relationship to study vaccine, severity and duration. No serious adverse events were reported during the study period. MPV ACYW135 showed a non-inferior immunogenicity profile and a comparable reactogenicity profile to MCV-4 in Malian children aged 2-10 years.: NCT04450498.
Topics: Humans; Meningococcal Vaccines; Vaccines, Conjugate; Neisseria meningitidis; Vaccination; Serogroup; Antibodies, Bacterial; Meningococcal Infections
PubMed: 37401618
DOI: 10.1080/21645515.2023.2230829 -
JAMA Jul 2023
Topics: Humans; COVID-19; COVID-19 Vaccines; Influenza Vaccines; Influenza, Human; Stroke; Vaccination; England; Vaccines, Combined
PubMed: 37318811
DOI: 10.1001/jama.2023.10123 -
Vaccine Jul 2023Real-world studies on vaccine effects are diverse in terms of objectives, study setting and design, data type and scope, and analysis methods. In this review, we... (Review)
Review
BACKGROUND
Real-world studies on vaccine effects are diverse in terms of objectives, study setting and design, data type and scope, and analysis methods. In this review, we describe and discuss four-component meningococcal serogroup B vaccine (4CMenB vaccine, Bexsero) real-world studies with the aim of synthesizing their findings with application of standard methods.
METHODS
We performed a systematic literature review of all real-world studies on 4CMenB vaccine effects on meningococcal serogroup B disease, with no restriction for population age, vaccination schedule and/or type of vaccine effect evaluated (vaccine effectiveness [VE] and vaccine impact [VI] outcomes) published since its licensure in 2013 (from January 2014 until July 2021) in PubMed, Cochrane and the grey literature. We then aimed to synthesize the findings of the identified studies through application of standard synthesis methods.
RESULTS
According to reported criteria we retrieved five studies presenting estimates on 4CMenB vaccine effectiveness and impact. These studies showed great diversity in population, vaccination schedule and analysis methods mainly due to diversity in vaccine strategies and recommendations in the study settings. Directed by this diversity, no quantitative pooling methods to synthesize findings could be applied; instead we descriptively assessed study methods. We report VE estimates ranging from 59% to 94% and VI estimates ranging from 31% to 75%, representing diverse age groups, vaccination schedules and analysis methods.
CONCLUSION
Both vaccine outcomes showed real-life effectiveness of 4CMenB vaccine despite differences in study methodologies and vaccination strategies. Based on appraisal of study methods, we highlighted the need for an adapted tool which facilitates synthesis of heterogenic real-world vaccine studies when quantitative pooling methods are not applicable.
Topics: Humans; Infant; Meningococcal Vaccines; Meningococcal Infections; Serogroup; Neisseria meningitidis, Serogroup B
PubMed: 37321895
DOI: 10.1016/j.vaccine.2023.05.025 -
Human Vaccines & Immunotherapeutics Dec 2023Invasive meningococcal disease is a life-threatening infection preventable through vaccination. Pediatric vaccination rates have declined during the coronavirus disease...
Invasive meningococcal disease is a life-threatening infection preventable through vaccination. Pediatric vaccination rates have declined during the coronavirus disease 2019 (COVID-19) pandemic. This survey aimed to understand how parents' attitudes and behaviors have changed during the pandemic with regard to immunization and, more specifically, meningococcal vaccination. An online survey was emailed to parents of eligible children 0-4 years, following the selection process from UK, France, Germany, Italy, Brazil, Argentina, and Australia; and of adolescents 11-18 years from US. Data collection took place 19 January-16 February 2021. Quotas were set to ensure a representative sample. Eleven questions relating to general perceptions around vaccination and attitudes and behaviors toward meningitis vaccination were displayed. On 4,962 parents (average 35 years) participating in the survey, most (83%) believed important for their child to continue receiving recommended vaccines during the COVID-19 pandemic. Nearly half of routine vaccine appointments were delayed or canceled due to the pandemic, and 61% of respondents were likely to have their children catch up once COVID-19 restrictions were lifted. 30% of meningitidis vaccination appointments were canceled or delayed during the pandemic, and 21% of parents did not intend to reschedule them because of lockdown/stay at home regulations, and fear of catching COVID-19 in public places. It is crucial to communicate clear instructions to health workers and the general population and to provide appropriate safety precautions in vaccination centers. This will help to maintain vaccination rates and limit infections to prevent future outbreaks.
Topics: Adolescent; Humans; Child; Pandemics; Health Knowledge, Attitudes, Practice; COVID-19; Communicable Disease Control; Meningococcal Infections; Vaccination; Meningococcal Vaccines; Surveys and Questionnaires; Parents
PubMed: 36883777
DOI: 10.1080/21645515.2023.2179840 -
The Journal of Infection Feb 2024This review details recent findings from the Global Meningococcal Initiative's (GMI) recent meeting on the surveillance and control strategies for invasive meningococcal... (Review)
Review
This review details recent findings from the Global Meningococcal Initiative's (GMI) recent meeting on the surveillance and control strategies for invasive meningococcal disease in the Middle East. The nature of case reporting and notification varies across the region, with many countries using bacterial meningitis as an IMD case definition in lieu of meningitis and septicaemia. This may overlook a significant burden associated with IMD leading to underreporting or misreporting of the disease. Based on these current definitions, IMD reported incidence remains low across the region, with historical outbreaks mainly occurring due to the Hajj and Umrah mass gatherings. The use of case confirmation techniques also varies in Middle Eastern countries. While typical microbiological techniques, such as culture and Gram staining, are widely used for characterisation, polymerase chain reaction (PCR) testing is utilised in a small number of countries. PCR testing may be inaccessible for several reasons including sample transportation, cost, or a lack of laboratory expertise. These barriers, not exclusive to PCR use, may impact surveillance systems more broadly. Another concern throughout the region is potentially widespread ciprofloxacin resistance since its use for chemoprophylaxis remains high in many countries.
Topics: Humans; Meningococcal Infections; Neisseria meningitidis; Middle East; Disease Outbreaks; Incidence; Meningococcal Vaccines; Serogroup
PubMed: 37866792
DOI: 10.1016/j.jinf.2023.10.011 -
Human Vaccines & Immunotherapeutics Dec 2023Invasive meningococcal disease (IMD) is rare but associated with high morbidity and mortality. In the United States, the most vulnerable age groups are infants and... (Review)
Review
Serum bactericidal activity against circulating and reference strains of meningococcal serogroup B in the United States: A review of the strain coverage of meningococcal serogroup B (MenB) vaccines in adolescents and young adults.
Invasive meningococcal disease (IMD) is rare but associated with high morbidity and mortality. In the United States, the most vulnerable age groups are infants and adolescents/young adults, and the most common type of IMD is caused by serogroup B (MenB). MenB is preventable among adolescents and young adults with the use of two licensed vaccines, MenB-FHbp (Trumenba®, bivalent rLP2086; Pfizer Inc, Collegeville, PA) and MenB-4C (Bexsero®; GSK Vaccines, Srl, Italy). Because the effectiveness of MenB vaccination is dependent on broad vaccine coverage across circulating disease-causing strains, we reviewed the available clinical and real-world evidence regarding breadth of coverage of the two licensed vaccines in adolescents and young adults in the United States. Both vaccines protect against various MenB strains. More controlled data regarding breadth of coverage across MenB strains are available for MenB-FHbp compared with MenB-4C, whereas more observational data regarding US outbreak strain susceptibility are available for MenB-4C.
Topics: Adolescent; Young Adult; Humans; United States; Serogroup; Meningococcal Infections; Meningococcal Vaccines; Vaccination; Neisseria meningitidis, Serogroup B; Italy; Antigens, Bacterial
PubMed: 37257838
DOI: 10.1080/21645515.2023.2212570 -
Vaccine Jul 2023Safety data on simultaneous vaccination (SV) with primary series monovalent COVID-19 vaccines and other vaccines are limited. We describe SV with primary series COVID-19...
INTRODUCTION
Safety data on simultaneous vaccination (SV) with primary series monovalent COVID-19 vaccines and other vaccines are limited. We describe SV with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged ≥5 years in the Vaccine Safety Datalink (VSD).
METHODS
We utilized VSD's COVID-19 vaccine surveillance data from December 11, 2020-May 21, 2022. Analyses assessed frequency of SV. Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was ≥5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving SV and COVID-19 vaccinees receiving no SV in the 1-21 days following COVID-19 vaccine dose 1 and 1-42 days following dose 2 by SV type received ("All SV", "Influenza SV", "Non-influenza SV").
RESULTS
SV with COVID-19 vaccines was not common practice (dose 1: 0.7 % of 8,455,037 persons, dose 2: 0.3 % of 7,787,013 persons). The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive SV (6.5 vs. 6.8 per 10,000 persons). Statistically significant elevated RRs were observed for appendicitis (2.09; 95 % CI, 1.06-4.13) and convulsions/seizures (2.78; 95 % CI, 1.10-7.06) in the "All SV" group following dose 1, and for Bell's palsy (2.82; 95 % CI, 1.14-6.97) in the "Influenza SV" group following dose 2.
CONCLUSION
Combined pre-specified health outcomes observed among persons who received SV with COVID-19 vaccine were rare and not statistically significantly different compared to persons who did not receive SV with COVID-19 vaccine. Statistically significant adjusted rate ratios were observed for some individual outcomes, but the number of outcomes was small and there was no adjustment for multiple testing.
Topics: Humans; COVID-19 Vaccines; COVID-19; Influenza Vaccines; Influenza, Human; Vaccination; Bacterial Vaccines
PubMed: 37344264
DOI: 10.1016/j.vaccine.2023.06.042 -
Infection and Immunity Dec 2023The bacterial pathogen is an urgent global health problem due to increasing numbers of infections, coupled with rampant antibiotic resistance. Vaccines against...
The bacterial pathogen is an urgent global health problem due to increasing numbers of infections, coupled with rampant antibiotic resistance. Vaccines against gonorrhea are being prioritized to combat drug-resistant . Meningococcal serogroup B vaccines such as four-component meningococcal B vaccine (4CMenB) are predicted by epidemiology studies to cross-protect individuals from natural infection with and elicit antibodies that cross-react with . Evaluation of vaccine candidates for gonorrhea requires a suite of assays for predicting efficacy and in animal models of infection, including the role of antibodies elicited by immunization. Here, we present the development and optimization of assays to evaluate antibody functionality after immunization of mice: antibody binding to intact , serum bactericidal activity, and opsonophagocytic killing activity using primary human neutrophils [polymorphonuclear leukocytes (PMNs)]. These assays were developed with purified antibodies against and used to evaluate serum from mice that were vaccinated with 4CMenB or given alum as a negative control. Results from these assays will help prioritize gonorrhea vaccine candidates for advanced preclinical to early clinical studies and will contribute to identifying correlates and mechanisms of immune protection against .
Topics: Humans; Mice; Animals; Meningococcal Vaccines; Neisseria gonorrhoeae; Gonorrhea; Meningococcal Infections; Neisseria meningitidis; Bacterial Vaccines; Antibodies; Vaccines, Combined; Antibodies, Bacterial; Neisseria meningitidis, Serogroup B; Antigens, Bacterial
PubMed: 37991382
DOI: 10.1128/iai.00309-23 -
Communicable Diseases Intelligence... Aug 2023We analysed Australian Immunisation Register (AIR) data as at 3 April 2022 for children, adolescents and adults for the calendar year 2021, with data on trends from...
INTRODUCTION
We analysed Australian Immunisation Register (AIR) data as at 3 April 2022 for children, adolescents and adults for the calendar year 2021, with data on trends from previous years also presented.
CHILDREN
'Fully vaccinated' coverage in Australian children in 2021 was 0.6-0.8 of a percentage point lower than in 2020 at the 12-month (94.2%) and 60-month (94.0%) age assessment milestones, but stable at the 24-month milestone (92.1%). Due to the lag time involved in assessment at milestone ages, 'fully vaccinated' coverage figures for 2020 and 2021 predominantly reflect vaccinations due in 2019 and 2020, respectively, and hence show a small impact on childhood coverage in the first year of the coronavirus disease 2019 (COVID-19) pandemic. 'Fully vaccinated' coverage in Aboriginal and Torres Strait Islander (hereafter respectfully referred to as Indigenous) children was 0.7-1.5 percentage points lower in 2021 than 2020 at the 12-month (91.6%), 24-month (90.1%) and 60-month (96.3%) milestones, although 2.3 percentage points higher than children overall at 60 months. Influenza vaccination coverage in children aged 6-59 months was approximately 20 percentage points lower in 2021 than 2020, both for children overall (26.5%) and for Indigenous children (22.5%). 'On time' vaccination (within 30 days of the recommended age) was up to two percentage points lower in 2021 than 2020 for vaccines due at 4 and 6 months of age, suggesting possible pandemic impacts, but was similar or higher for vaccines due at 12 months of age. While on-time vaccination in Indigenous children has improved progressively since 2012, it remained 6-13 percentage points lower than in children overall in 2021. 'Fully vaccinated' coverage at the earlier milestones (3 months after due date of last scheduled vaccine) of 9, 15, 21 and 51 months was 1.5-2.8 percentage points lower for children living in the least advantaged residential area quintile than the most advantaged, a similar disparity as in 2020. Coverage at the earlier milestones was 2.3-10.0 percentage points lower for Indigenous children living in remote areas than in major cities and regional areas, with disparity at 21 months of age 2.1-2.2 percentage points higher in 2021 than in 2020, and 1.2-2.1 percentage points higher at 51 months.
ADOLESCENTS
In 2021, a total of 80.3% of girls and 77.2% of boys (and 73.3% and 66.2% of Indigenous girls and boys) had completed the human papillomavirus (HPV) vaccination schedule by 15 years of age, 0.2-0.4 of a percentage point lower than 2020 (1.7-1.8 percentage points for Indigenous), reflecting vaccinations due in school programs prior to the pandemic with possible pandemic impact on catch-up vaccination. However, the proportion of adolescents completing the two-dose HPV vaccination schedule within a calendar year was 15.3 percentage points lower in 2021 than 2020 and 26.9 percentage points lower than in 2019, likely due to pandemic-related disruption to school-based programs. Additionally, 87.3% of adolescents (83.8% for Indigenous) had received the recommended booster dose of diphtheria-tetanus-acellular pertussis (dTpa) vaccine by 15 years, and 76.1% (66.7% for Indigenous) the recommended meningococcal ACWY vaccine dose by 17 years of age.
ADULTS
Zoster vaccine coverage in 2021 remained relatively low, at just over 30%, in adults aged 70 years, but increased to 47% in those aged 71-79 years, reflecting ongoing catch-up vaccination. Coverage of 13vPCV was low in 2021, reaching 17.2% in adults aged 70 years and 20.1% in those aged 71-79 years. Influenza vaccination coverage in adults in 2021 was progressively higher with increasing age, reaching 62.1% in the 65-74 years age group (64.6% in Indigenous) and 68.5% in the 75+ years age group (67.7% in Indigenous). Influenza vaccine coverage for other National Immunisation Program (NIP)-eligible Indigenous adult age groups was only 22.0% for those aged 20-49 years, and 43.5% for those aged 50-64 years. By the end of 2021, a total of 91.6% of people in Australia aged 16+ years had received a second dose of a COVID-19 vaccine (71.8% for Indigenous), with over 99% of those aged 70+ years having received a second dose.
CONCLUSIONS
Vaccination coverage in children and adolescents remained relatively high in 2021, although with some evidence of COVID-19 pandemic impacts, particularly on receipt of two doses of HPV vaccine within the same calendar year. It will be important to ensure catch-up vaccination in children and adolescents occurs. A strengthened focus on adult vaccination is needed, as coverage remained suboptimal in 2021. The impact of mandatory reporting of all NIP vaccinations from mid-2021, on completeness of AIR data, has not yet been formally evaluated.
Topics: Child; Adult; Male; Adolescent; Female; Humans; Infant; Aged; Vaccination Coverage; Papillomavirus Infections; COVID-19 Vaccines; Influenza, Human; Pandemics; Australia; Influenza Vaccines; Papillomavirus Vaccines; COVID-19
PubMed: 37817316
DOI: 10.33321/cdi.2023.47.47