Human Vaccines & Immunotherapeutics最新文献

The utilization of immune-checkpoint inhibitors (ICIs) in cancer immunotherapy frequently leads to the occurrence of immune-related adverse events (irAEs), making it generally not recommended for patients with preexisting autoimmune diseases. Hence, we conducted a meta-analysis on safety and efficacy of ICIs in cancer patients with preexisting autoimmune diseases to provide further insights. PubMed, EMBASE, and Cochrane Library were systematically searched until December 20, 2024. The main summary measures used were pooled rate and risk ratio (RR) with 95% confidential interval (CI), which were analyzed using R statistic software. A total of 52 articles were included in the study. When cancer patients with preexisting autoimmune diseases received ICIs treatment, the overall incidence was 0.610 (95% CI: 0.531-0.686) for any grade irAEs, 0.295 (95% CI: 0.248-0.343) for flares, 0.325 (95% CI: 0.258-0.396) for de novo irAEs, 0.238 (95% CI: 0.174-0.309) for grade ≥3 irAEs, and 0.143 (95% CI: 0.109-0.180) for discontinuation due to immunotoxicity. Compared with those without autoimmune diseases, cancer patients with autoimmune diseases experienced a higher risk of any-grade irAEs (RR: 1.23, 95% CI: 1.12-1.35) and discontinuation due to immunotoxicity (1.40, 95% CI: 1.11-1.78). However, no statistically significant differences were observed in the incidence of grade ≥3 irAEs, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) between the two groups. During ICIs treatment, irAEs are common among cancer patients with autoimmune diseases, but severe irAEs is relatively low. ICIs are effective in this population, but should be strictly monitored when used to avoid immunotoxicity.

Chickenpox outbreaks frequently occur in collective settings such as kindergartens and schools, posing a significant threat to children's physical and mental health. This study aimed to evaluate the immunogenicity and safety of the freeze-dried live attenuated varicella vaccine (VarV) developed by Beijing Minhai Biotechnology Co. LTD. in healthy participants aged 1-12 years. In this phase III, single-center, randomized, double-blind, active-controlled trial,1,200 healthy participants randomly assigned in a 1:1 ratio to receive one dose of either the test vaccine or the active control vaccine. Venous blood samples were collected before vaccination and 42 days after vaccination, and the fluorescent antibody to membrane antigen (FAMA) assay was used to detect VZV antibody. Adverse events (AEs) observed within 42 days after vaccination and serious adverse events (SAEs) within six months after vaccination were recorded. The seroconversion rates in the test and control groups were 96.79% and 96.43%, respectively, with a difference of 0.36% (95% CI, -1.76%-2.48%). The geometric mean titers (GMTs) were 61.74 and 58.04, respectively, with a difference of 1.06 (95% CI, 0.92-1.23). The lower limits of the 95% CI for the differences in seroconversion rates and GMT ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of AEs (p = .0112) in the test group was significantly lower than that in the control group. The freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co. LTD. demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 1-12 years.

Achieving safe influenza vaccination coverage among pregnant and breastfeeding women is a global health goal due to the potential risks of serious influenza for both mother and child. However, vaccine hesitancy remains a significant barrier to vaccination uptake. Since anxiety represents a determinant in vaccine decision-making, this study aimed to assess influenza vaccination hesitancy and anxiety levels in this population and to explore the association between women's characteristics, their reluctance, and anxiety levels. A multicentre, cross-sectional study was conducted between February and June 2022 using structured phone interviews to assess: (1) socio-demographics and clinical history; (2) anti-flu vaccination status, previous anti-flu vaccination, and Sars-CoV-2 infection history; (3) insights into influenza vaccination during pregnancy; (4) attitudes toward anti-flu vaccination, using the Vaccination Attitudes Examination (VAX) Scale; (5) anxiety levels, measured by the Self-Rating Anxiety Scale (SAS). Among the 387 participants, 22.8% were already vaccinated or expressed willingness to be vaccinated against influenza, and 54% had an anxiety disorder. While anxiety was not significantly associated with vaccine hesitancy, ongoing pregnancy emerged as an independent predictor of anxiety. Higher educational levels, ongoing pregnancy, already being vaccinated or willingness to get vaccinated, and being employed were associated with reduced vaccine hesitancy, while prior SARS-CoV-2 infection with increased hesitancy. Fear of unpredictable events and lack of healthcare professionals' recommendations emerged as reasons for vaccine reluctance. Given the low coverage rates, these findings highlight the need for health services to enhance vaccination efforts and provide clear recommendations to counter misinformation and ensure accurate vaccine safety information.

Human papillomavirus (HPV) vaccination could reduce HPV infection in men who have sex with men (MSM), but the published statistics on HPV vaccination uptake in MSM were scarce globally. This study estimated the uptake and profiled the service preferences of HPV vaccination of Chinese MSM in Hong Kong. Adult MSM were recruited through non-governmental organizations (NGOs) and online channels for completing an online baseline survey. Factors associated with self-reported history of HPV vaccination were identified using multivariable stepwise logistic regression model. Totally 701 Chinese MSM completed the online baseline survey, with the median age of 30 y (interquartile range [IQR] 26-35, range 18-67), and 23% of them had received HPV vaccination. More than half of vaccinated MSM (72%) rated convenient or very convenient for local HPV vaccination services. Among unvaccinated MSM, 50% considered high cost of HPV vaccine as the barrier of vaccination, 67% expressed willingness to pay below USD 128 per vaccine dose, and 65% preferred receiving vaccination in private clinics. MSM who had taken HIV pre-exposure prophylaxis (PrEP) (p < .001), had been tested for HPV (p = .018), and had (p = .005) multiple regular sex partners in the past 6 months were more likely to be vaccinated. The HPV vaccination uptake of Chinese MSM in Hong Kong remains low (23%), and high HPV vaccine cost is the main barrier. Preventive behaviors (HIV PrEP use and HPV testing) and high-risk sexual behavior (multiple regular sex partners) are potential targets for intervention to increase the uptake of HPV vaccination in MSM.

From 2020, influenza viruses circulation was largely affected by the global coronavirus disease (COVID-19) pandemic, notably leading to the extinction of the B/Yamagata lineage and raising questions about the relevance of the quadrivalent influenza vaccine, which includes this lineage. Evaluating vaccine effectiveness (VE) against influenza infections is important to inform future vaccine programs. A test-negative case-control study was conducted in five tertiary hospitals in Hangzhou, the capital city of Zhejiang province, China, enrolling medically-attended patients aged >6 months who presented with influenza-like illness (ILI) from October 1, 2023, to March 31, 2024. The VE was estimated using multivariate logistic regression models adjusted for sex, age, influenza detection methods, and influenza testing timing. Of the 157,291 medically-attended ILI participants enrolled 56,704 (36%) tested positive for influenza. Adjusted overall VE against any medically-attended influenza infection was 48% (95% Confidence interval [CI]: 46%-51%). The overall VE of the trivalent inactivated influenza vaccine (IIV3) was 59% (95% CI: 50%-66%), followed by the trivalent live attenuated vaccine (LAIV3) (VE = 53%, 95% CI: 42%-62%) and quadrivalent inactivated influenza vaccine (IIV4) (VE = 47%, 95% CI: 45%-50%). IIV3 provided even better protection against medically-attended influenza B infection than IIV4 (VE = 87%, 95% CI: 81%-92% for IIV3 versus VE = 53%, 95% CI: 50%-57% for IIV4). In the 2023/24 season in Hangzhou, China, the influenza vaccine offered moderate protection during a major epidemic. The results supported the World Health Organization recommendation to exclude the B/Yamagata lineage antigen in quadrivalent influenza vaccines in 2023.

Cholangiocarcinoma (CCA) is a highly malignant hepatobiliary tumor characterized by limited treatment options and poor prognosis. The recent rise of immunotherapy has significantly influenced research in this field. This study presents a bibliometric analysis of 416 articles retrieved from the WOSCC, Wan fang Data, CNKI and VIP databases, spanning contributions from 32 countries, 589 institutions and 3,200 authors. The analysis identified "PD-L1," "PD-1" and "pembrolizumab" as central research foci, while "immune checkpoint inhibitors," "tumor immune microenvironment," "tertiary lymphoid structures" and "durvalumab" emerged as key areas of interest. These findings emphasize the pivotal role of immunotherapy in improving survival outcomes for CCA, and they highlight the significance of tertiary lymphoid structures within the tumor microenvironment as a promising target for future research. This study offers a strategic overview of the evolving landscape of CCA immunotherapy, providing valuable insights to guide future scientific endeavors in this domain.

mRNA vaccines offer groundbreaking technological advantages and broad application potential. Their rapid advancement, particularly during the COVID-19 pandemic, is the result of decades of research and numerous technological breakthroughs. These discoveries build upon each other, forming dense, interconnected networks of progress. Studying the technological development paths of mRNA vaccines is therefore essential. Main path analysis (MPA) is particularly effective for mapping out development trajectories within complex and interconnected networks, which serves as a powerful tool for identifying key nodes and innovations. This study introduces a novel approach to extracting main paths from a patent citation network in the mRNA vaccine field. Initially, we shielded edges connecting the origin and terminus patents. Subsequently, we extracted the main paths from intermediate patents, and then, we reintegrated the edges connecting the origin and terminus patents based on the citation relationships, resulting in a comprehensive extraction of the main paths. The research findings indicate a consistency among the global main paths, global key-route main paths, local forward main paths, and local key-route main paths within the mRNA vaccine field. The patents on the main paths predominantly focus on nucleic acid modifications and delivery systems. The local backward main paths identify a greater number of patents, especially those related to litigation, offering a richer and more diverse set of technological insights. This study significantly advances the methodology of MPA, with the innovative shielding technique offering a fresh perspective for navigating complex networks and providing a deeper understanding of technological development in the mRNA vaccine domain.

Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2-negative and -positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified.

Chikungunya virus (CHIKV), transmitted through Aedes mosquitoes, is a significant global health concern. Various vaccine platforms have been explored to combat CHIKV, including formalin inactivation, live-attenuated strains, virus-like particles (VLPs), viral vectors, and mRNA technologies. This umbrella review synthesizes evidence on the safety profiles of vaccine platforms used in Chikungunya vaccines that have been applied in other vaccines, focusing on adverse events of special interest (AESI) in pregnant persons, children, and adolescents. A comprehensive overview of systematic reviews (SRs) was conducted. Results: Seven systematic reviews were included and complemented with primary studies. Vaccines like influenza, human papillomavirus (HPV), and COVID-19, which share platforms with Chikungunya vaccines, showed no significant increase in AESI. Moderate-to high-quality SRs supported favorable safety profiles. Vaccines sharing platforms with Chikungunya vaccines generally exhibit acceptable safety profiles in pregnant persons, children, and adolescents.

Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer - the Centers for Disease Control and Prevention - itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments - for patients to better understand their health, the threat of disease, and the weight of their contribution to the public - should not be squandered.