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International Journal of Infectious... Jun 2024We evaluated the changes and molecular epidemiology of meningococcal carriage in military recruits after quadrivalent meningococcal conjugate vaccines (MenACWY)...
Effectiveness of quadrivalent meningococcal conjugate vaccine against meningococcal carriage and genotype character changes: A secondary analysis of prospective cohort study in Korean military trainees.
OBJECTIVE
We evaluated the changes and molecular epidemiology of meningococcal carriage in military recruits after quadrivalent meningococcal conjugate vaccines (MenACWY) vaccination.
METHODS
Oropharyngeal swabs were obtained at the beginning and end of the 5-week training. Carriage rates before and after vaccination were compared to estimate vaccine effectiveness (VE). Cultured isolates were characterized by multi-locus sequence typing (MLST).
RESULTS
Of 866 vaccinated participants, the overall carriage rate was 10.6% prior to MenACWY vaccination and it tended to decrease to 9.5% after 5 weeks of vaccination (P =0.424). Carriage rate of serogroup ACWY decreased significantly after vaccination (VE = 72.6%, 95%CI: 36.3 - 88.2%), and serogroup C was particularly reduced (VE = 83.0%, 95%CI: 50.6 - 94.1%), whereas nongroupable isolates increased significantly after vaccination (VE = -76.1%, 95%CI: -176.2 - -13.1%). Among 99 carriage isolates with complete MLST profiles, 45 different sequence types with nine clonal complexes (CCs) were identified, and 35.3% of the carriage isolates belonged to hypervirulent strains such as CC-32, CC-41/44, and CC-269.
CONCLUSIONS
MenACWY vaccination in military recruits led to reduced carriage rates of serogroups C, W, and Y within a short 5-week period. However, serogroup B isolates belonging to the hypervirulent lineage remained after the implementation of MenACWY vaccination.
PubMed: 38914368
DOI: 10.1016/j.ijid.2024.107150 -
The Pediatric Infectious Disease Journal Jun 2024Asthma is the most common chronic medical condition among children ≥5 years of age with invasive pneumococcal disease. How asthma or its management affects...
BACKGROUND
Asthma is the most common chronic medical condition among children ≥5 years of age with invasive pneumococcal disease. How asthma or its management affects pneumococcal colonization is not fully understood. Our objective was to compare pneumococcal colonization rates between children with persistent asthma and children without asthma, and to characterize the pneumococcal serotype distribution.
METHODS
We used nasal mid-turbinate samples obtained per routine care from 5- to 18-year-old children with upper respiratory symptoms from November to April (respiratory seasons) of 2017 to 2018 and 2018 to 2019 in Kansas City, United States. Pneumococcal immunization status, prior antibiotic use and other clinical data were collected. Samples were tested for pneumococcal colonization by real-time polymerase chain reaction targeting lytA gene. Positive samples underwent multiplex serotype-specific polymerase chain reaction assays to determine the serotype.
RESULTS
Of 363 children (120 with persistent asthma and 243 without asthma), 87.6% were 5 to 10 years old, 50.1% were female and 74.1% received ≥3 doses of a pneumococcal conjugate vaccine. The pneumococcal colonization rate was lower in children with persistent asthma than in children without asthma (10% versus 18.9%, P = 0.03). The odds of colonization were lower in children with persistent asthma [OR 0.4 (95% confidence interval: 0.2-0.9)] after adjusting for demographic and clinical data. Pneumococcal serotype was confirmed in 77.6% of positive samples; 35.6% of those samples corresponded to PCV13 serotypes and 64.4% to non-PCV13 serotypes. The most common serotypes were 19F (15%), 3 (13%) and 6C/6D (11%).
CONCLUSIONS
Children with persistent asthma had lower rates of pneumococcal colonization than children without asthma when seeking care for respiratory symptoms.
PubMed: 38900076
DOI: 10.1097/INF.0000000000004438 -
Vaccine Jun 2024Meningococcal disease is caused by Neisseria meningitidis or meningococcus. Every year globally around 1.2 million people are affected and approximately 120,000 deaths...
Meningococcal disease is caused by Neisseria meningitidis or meningococcus. Every year globally around 1.2 million people are affected and approximately 120,000 deaths occur due to meningitis. The disease can be prevented by a single dose of meningococcal vaccine. We carried out a randomized observer-blinded non-inferiority trial to evaluate and compare the immunogenicity and safety of a local meningococcal polysaccharide vaccine 'Ingovax ACWY' (test) with Quadri Meningo (comparator), an approved meningococcal polysaccharide vaccine in India. A total of 88 healthy adults (18-45 years old) were randomized at a 1:1 ratio in two vaccine groups receiving a single dose vaccine subcutaneously. All participants were followed until three months post-vaccination. Blood for clinical parameters (hematology and biochemistry) and serum bactericidal assay (SBA) was collected prior to vaccination and one-month post-vaccination. Solicited adverse events (AEs) were assessed up to 6 days following vaccination and unsolicited AEs were monitored throughout the follow-up period. There was no significant difference in rates of AE between the two groups. The commonest solicited AE was injection site pain. No serious AEs were reported. There was no significant difference (p<0.05) in seroconversion rate as well as pre and post-vaccination SBA geometric mean titers (GMT)between test and comparator vaccine. The post-vaccination GMT ratio (GMR) of the test and comparator vaccine was found to be 0.9, 1, 1.29, and 0.85 for serogroup A, C, W135, and Y respectively. For all the serogroups, lower limit of 95% CI of the GMR was found to be greater than the pre-defined 0.5 non-inferiority margin suggesting that Ingovax ACWY is similar to Quadri Meningo vaccine. We observed the immunogenicity and safety of Ingovax ACWY is non-inferior to comparator vaccine. The development of facilities for manufacturing polysaccharide ACWY vaccines locally will further lead to capacity building in the field of vaccines for Bangladesh.
PubMed: 38897895
DOI: 10.1016/j.vaccine.2024.06.030 -
Healthcare (Basel, Switzerland) May 2024Data on the health-related quality of life (HRQoL) for invasive meningococcal disease (IMD) survivors, particularly among adolescents and young adults (AYAs), are...
BACKGROUND
Data on the health-related quality of life (HRQoL) for invasive meningococcal disease (IMD) survivors, particularly among adolescents and young adults (AYAs), are limited. This study aimed to investigate the in-depth experiences and impacts of IMD on AYAs.
METHODS
Participants were recruited from two Australian states, Victoria and South Australia. We conducted qualitative, semi-structured interviews with 30 patients diagnosed with IMD between 2016 and 2021. The interview transcripts were analyzed thematically.
RESULTS
Of the participants, 53% were aged 15-19 years old, and 47% were aged 20-24. The majority (70%) were female. Seven themes relating to the participants' experience of IMD were identified: (1) underestimation of the initial symptoms and then rapid escalation of symptoms; (2) reliance on social support for emergency care access; (3) the symptoms prompting seeking medical care varied, with some key symptoms missed; (4) challenges in early medical diagnosis; (5) traumatic and life-changing experience; (6) a lingering impact on HRQoL; and (7) gaps in the continuity of care post-discharge.
CONCLUSION
The themes raised by AYA IMD survivors identify multiple areas that can be addressed during their acute illness and recovery. Increasing awareness of meningococcal symptoms for AYAs may help reduce the time between the first symptoms and the first antibiotic dose, although this remains a challenging area for improvement. After the acute illness, conducting HRQoL assessments and providing multidisciplinary support will assist those who require more intensive and ongoing assistance during their recovery.
PubMed: 38891151
DOI: 10.3390/healthcare12111075 -
American Journal of Men's Health 2024Men aged 27 to 45 are eligible for human papillomavirus (HPV) vaccination as of 2019, yet relatively little is known about whether they have received or intend to...
Men aged 27 to 45 are eligible for human papillomavirus (HPV) vaccination as of 2019, yet relatively little is known about whether they have received or intend to receive it. We conducted a cross-sectional, online survey among fathers aged 27 to 45 between March and April 2022, to assess associations between HPV vaccination awareness, behaviors, intentions, and psychosocial constructs from the Health Belief Model. We examined the characteristics of those who had (a) heard of the HPV vaccine, (b) already received ≥ 1 dose, and (c) intentions for future vaccination among those who had never been vaccinated. Among 400 men who completed the survey, 32% were not aware of the HPV vaccine. Among those who were aware, 41% had received ≥ 1 dose. Sixty-three percent of unvaccinated men reported that they intended to get vaccinated in the future. Multivariable logistic regression analyses revealed that age and race/ethnicity were associated with having been vaccinated previously. Among the unvaccinated, multivariable logistic regression analyses revealed that those with a higher perceived risk of HPV-associated cancer had 3.73 greater odds of reporting they would seek vaccination compared to those with lower perceived risk (95% confidence interval [CI] = [1.28, 12.3]). We did not find perceived benefits, barriers, or decision self-efficacy to be related to future vaccine intentions. Since recommendations for this group include shared clinical decision-making, public health efforts should focus on raising awareness of vaccine eligibility, emphasizing risk factors for HPV-associated cancers so that individuals have an accurate perception of risk, and encouraging conversation between men and their providers.
Topics: Humans; Male; Papillomavirus Vaccines; Adult; Cross-Sectional Studies; Middle Aged; Fathers; Health Knowledge, Attitudes, Practice; Intention; Papillomavirus Infections; Surveys and Questionnaires; Vaccination
PubMed: 38879825
DOI: 10.1177/15579883241258823 -
Carbohydrate Polymers Oct 2024Meningococcal glycoconjugate vaccines sourced from capsular polysaccharides (CPSs) of pathogenic Neisseria meningitidis strains are well-established measures to prevent...
Meningococcal glycoconjugate vaccines sourced from capsular polysaccharides (CPSs) of pathogenic Neisseria meningitidis strains are well-established measures to prevent meningococcal disease. However, the exact structural factors responsible for antibody recognition are not known. CPSs of Neisseria meningitidis serogroups Y and W differ by a single stereochemical center, yet they evoke specific immune responses. Herein, we developed specific monoclonal antibodies (mAbs) targeting serogroups C, Y, and W and evaluated their ability to kill bacteria. We then used these mAbs to dissect structural elements responsible for carbohydrate-protein interactions. First, Men oligosaccharides were screened against the mAbs using ELISA to select putative lengths representing the minimal antigenic determinant. Next, molecular interaction features between the mAbs and serogroup-specific sugar fragments were elucidated using STD-NMR. Moreover, X-ray diffraction data with the anti-MenW CPS mAb enabled the elucidation of the sugar-antibody binding mode. Our findings revealed common traits in the epitopes of all three sialylated serogroups. The minimal binding epitopes typically comprise five to six repeating units. Moreover, the O-acetylation of the neuraminic acid moieties was fundamental for mAb binding. These insights hold promise for the rational design of optimized meningococcal oligosaccharides, opening new avenues for novel production methods, including chemical or enzymatic approaches.
Topics: Antibodies, Monoclonal; Serogroup; Neisseria meningitidis; Meningococcal Vaccines; Polysaccharides, Bacterial; Antibodies, Bacterial; Epitopes; Animals; Mice; Humans; Bacterial Capsules; Antibody Formation
PubMed: 38876728
DOI: 10.1016/j.carbpol.2024.122349 -
Current Medical Research and Opinion Jun 2024In 2019, the United States Advisory Committee on Immunization Practices (ACIP) updated their meningococcal serogroup B (MenB) vaccination recommendation for...
OBJECTIVE
In 2019, the United States Advisory Committee on Immunization Practices (ACIP) updated their meningococcal serogroup B (MenB) vaccination recommendation for 16-23-year-olds from individual to shared clinical decision-making (SCDM). SCDM recommendations are individually based and informed by a decision process between patients and healthcare providers (HCPs). MenB vaccination among 16-23-year-olds remains low. We examined recorded conversations in which MenB vaccine-related discussions between HCPs and patients/caregivers took place, and how these interactions changed following the updated SCDM recommendation.
METHODS
An analysis of recordings where MenB vaccination was discussed between HCPs and patients (16-23 years old)/caregivers was conducted using retrospective anonymized dialogue data (January 2015-October 2022). Shared decision-making strength was measured using a modified OPTION5 framework.
RESULTS
Of 97 included recorded conversations, the average duration was 11.3 min. Within these conversations, MenB disease was discussed for 0.25 min (38.9% of words in total vaccine-preventable diseases discussion) and MenB vaccination was discussed for 1.36 min (60.9% of words in total vaccine discussion), on average. HCPs spoke 78.8% of MenB vaccine-related words and most (99.0%) initiated the MenB vaccination discussion. In 40.2% of recordings, HCPs acknowledged the MenB vaccine without providing a clear recommendation. HCP recommendations often favored MenB vaccination (87.0%) and recommendations were 21.4% stronger post-recommendation change to SCDM. As measured by the modified OPTION5 framework, most recordings did not reflect a high degree of shared decision-making between HCPs and patients/caregivers.
CONCLUSIONS
MenB vaccination discussions were brief, and the degree of shared decision-making was low. Targeted education of HCPs and patients/caregivers may improve MenB vaccination awareness, SCDM implementation, and vaccine uptake.
PubMed: 38860982
DOI: 10.1080/03007995.2024.2362924 -
Arthritis Research & Therapy Jun 2024The objective of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF‑06835375, a potent selective afucosyl immunoglobulin... (Randomized Controlled Trial)
Randomized Controlled Trial
A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis.
BACKGROUND
The objective of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF‑06835375, a potent selective afucosyl immunoglobulin G1 antibody targeting C-X-C chemokine receptor type 5 (CXCR5) that potentially depletes B cells, follicular T helper (Tfh) cells, and circulating Tfh-like (cTfh) cells, in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
METHODS
This first-in-human, multicenter, double-blind, sponsor-open, placebo-controlled Phase 1 study recruited patients aged 18-70 years with SLE or RA. In Part A, patients received single doses of intravenous PF-06835375 (dose range: 0.03-6 mg) or placebo in six sequential single ascending dose (SAD) cohorts. In Part B, patients received repeat doses of subcutaneous PF-06835375 (dose range: 0.3-10 mg) or placebo on Days 1 and 29 in five multiple ascending dose (MAD) cohorts. Tetanus/Diphtheria (Td) and Meningococcal B (MenB/Trumenba™) vaccines were administered at Day 4 (Td and MenB) and Week 8 (MenB only) to assess PF-06835375 functional effects. Endpoints included treatment-emergent adverse events (TEAEs), pharmacokinetic parameters, pharmacodynamic effects on B and cTfh cells, and biomarker counts, vaccine response, and exploratory differential gene expression analysis. Safety, pharmacokinetic, and pharmacodynamic endpoints are summarized descriptively. The change from baseline of B and Tfh cell-specific genes over time was calculated using a prespecified mixed-effects model, with a false discovery rate < 0.05 considered statistically significant.
RESULTS
In total, 73 patients were treated (SAD cohorts: SLE, n = 17; RA, n = 14; MAD cohorts: SLE, n = 22; RA, n = 20). Mean age was 53.3 years. Sixty-two (84.9%) patients experienced TEAEs (placebo n = 17; PF-06835375 n = 45); most were mild or moderate. Three (9.7%) patients experienced serious adverse events. Mean t ranged from 3.4-121.4 h (SAD cohorts) and 162.0-234.0 h (MAD cohorts, Day 29). B and cTfh cell counts generally showed dose-dependent reductions across cohorts (range of mean maximum depletion: 67.3-99.3%/62.4-98.7% [SAD] and 91.1-99.6%/89.5-98.1% [MAD], respectively). B cell-related genes and pathways were significantly downregulated in patients treated with PF-06835375.
CONCLUSIONS
These data support further development of PF-06835375 to assess the clinical potential for B and Tfh cell depletion as a treatment for autoimmune diseases.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03334851.
Topics: Humans; Middle Aged; Adult; Double-Blind Method; Female; Male; Lupus Erythematosus, Systemic; Arthritis, Rheumatoid; Aged; Receptors, CXCR5; Young Adult; Dose-Response Relationship, Drug; Adolescent; Antibodies, Monoclonal, Humanized; Antirheumatic Agents
PubMed: 38845046
DOI: 10.1186/s13075-024-03337-2 -
MMWR. Morbidity and Mortality Weekly... Jun 2024Invasive meningococcal disease (IMD), caused by infection with the bacterium Neisseria meningitidis, usually manifests as meningitis or septicemia and can be severe and...
Invasive meningococcal disease (IMD), caused by infection with the bacterium Neisseria meningitidis, usually manifests as meningitis or septicemia and can be severe and life-threatening (1). Six serogroups (A, B, C, W, X, and Y) account for most cases (2). N. meningitidis is transmitted person-to-person via respiratory droplets and oropharyngeal secretions. Asymptomatic persons can carry N. meningitidis and transmit the bacteria to others, potentially causing illness among susceptible persons. Outbreaks can occur in conjunction with large gatherings (3,4). Vaccines are available to prevent meningococcal disease. Antibiotic prophylaxis for close contacts of infected persons is critical to preventing secondary cases (2).
Topics: Humans; Meningococcal Infections; United States; France; Saudi Arabia; Young Adult; Adult; Adolescent; Male; Female; Neisseria meningitidis; Child; Child, Preschool; United Kingdom; Middle Aged; Infant; Aged; Travel-Related Illness; Disease Outbreaks; Travel
PubMed: 38843099
DOI: 10.15585/mmwr.mm7322e1 -
Revista Paulista de Pediatria : Orgao... 2024To analyze the vaccination coverage and abandonment rates among children under two years old in Brazil, from 2015 to 2021.
OBJECTIVE
To analyze the vaccination coverage and abandonment rates among children under two years old in Brazil, from 2015 to 2021.
METHODS
A time-series ecological study. The dependent variables of the research were "vaccination coverage" and "abandonment rate", both assessed by Brazilian region. The data were extracted in July 2022 from the Information System of the National Immunization Program. The Prais-Winsten technique was used for the trend analysis, with the aid of the STATA 16.0 software.
RESULTS
The mean vaccination coverage in Brazil was 76.96%, with a decreasing trend during the period (Annual Percent Change=-5.12; confidence interval - CI95% -7.81; -2.34); in 2015, the rate was 88.85% and it dropped to 62.35% in 2021. In turn, the overall abandonment rate was 24.00% in 2015 and 9.01% in 2021, with a mean of 10.48% and a stationary trend (Annual Percentage Change=-9.54; CI95% -22.92; 6.12). In 2021, all the vaccines presented coverage values below 74.00% in the country.
CONCLUSIONS
The vaccination coverage rate trend among children under two years old was stationary or decreasing for all the immunobiologicals in all Brazilian regions, with the exception of yellow fever in the South and Southeast regions. There was an increase in the abandonment rate trend for the Meningococcal C vaccine in the country and, specifically in relation to the regions, for BCG in the North, Northeast, and Midwest and for Meningococcal C in the North and Northeast.
Topics: Humans; Brazil; Vaccination Coverage; Infant; Immunization Programs; Vaccination; Time Factors
PubMed: 38836806
DOI: 10.1590/1984-0462/2024/42/2023116