Therapeutic Advances in Vaccines and Immunotherapy最新文献

Background: Lyme disease, the most common vector-borne illness in the Northern Hemisphere, is caused by Borrelia burgdorferi and transmitted via tick bites. With rising global incidence and no approved human vaccine, VLA15, a novel recombinant vaccine targeting six OspA serotypes, shows promise as an effective preventive strategy.

Objective: This study aims to assess the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk populations.

Design: We conducted a systematic review and meta-analysis of three randomized controlled trials.

Methods: This systematic review and meta-analysis, registered in PROSPERO (CRD420251058818), was conducted following PRISMA guidelines. A thorough search of PubMed, EMBASE, Cochrane Library, Scopus, ScienceDirect, and ClinicalTrials.gov was performed up to May 2025. Data extraction and quality assessment (using Cochrane ROB 2) were performed independently by reviewers. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using random-effects models.

Results: Three RCTs, including 5907 participants (4500 VLA15; 1407 placebo), met inclusion criteria. VLA15 recipients showed a significantly higher risk of adverse events: fever (RR 2.65, 95% CI: 1.77-3.96), headache (RR 1.40, 95% CI: 1.21-1.62), fatigue (RR 1.33, 95% CI: 1.15-1.55), and arthralgia (RR 2.50, 95% CI: 1.67-3.76), all with p < 0.0001. Subgroup analysis revealed a dose-response trend for arthralgia, particularly at 135 μg and 180 μg doses. However, nausea (RR = 1.34, p = 0.10) and severe unsolicited AEs (RR = 1.22, p = 0.42) were not statistically significant, suggesting no meaningful increase in these risks. Immunogenicity outcomes consistently favored VLA15, showing elevated IgG levels, GMTs, and seroconversion rates.

Conclusion: VLA15 exhibits strong immunogenicity and acceptable safety, despite an increased risk of mild-to-moderate adverse events. Continued research and monitoring are warranted to support its use in Lyme disease prevention.

Global vaccine hesitancy, intensified by crises such as the COVID-19 pandemic, represents a significant threat to immunization coverage. This narrative review discusses immunization safety monitoring frameworks and vaccine hesitancy in crisis-affected regions, particularly in Lebanon, Ukraine, and Sudan. By examining and reflecting on these case studies, this review aims to examine challenges, highlight context-specific strategies, and propose solutions for enhancing vaccine uptake and trust in fragile and conflict-affected areas. A structured narrative review was conducted, collecting evidence from global frameworks and region-specific case studies. The review explored factors impacting vaccine hesitancy, the role of adverse events following immunization (AEFI) monitoring systems, and innovative technological interventions. Key sources included peer-reviewed articles, reports from humanitarian organizations, and systematic reviews. The review showed that vaccine hesitancy is affected by interconnected factors, including sociopolitical and cultural conflicts, and misinformation. Lebanon's persistent economic and political instability, Ukraine's disruptions caused by the ongoing war, and Sudan's fragile healthcare infrastructure pose challenges to vaccine coverage. Successful interventions to address hesitancy included transparency in AEFI reporting, integration of real-time monitoring systems, and community-led initiatives. It is critical to mitigate vaccine hesitancy in crisis-affected regions through robust safety monitoring frameworks and tailored communication strategies. Global cooperation and frameworks, technological innovations, and context-specific approaches are imperative for improving the resilience of immunization systems and ensuring health security in fragile settings. Furthermore, these insights are crucial in informing public health communication policies and behavior change interventions to improve public trust and thus reduce vaccine hesitancy.

Background: The vaccination for human papillomavirus (HPV) is a widely acknowledged global measure aimed at preventing cervical cancer. However, the rate of vaccine adoption differs across various regions and countries due to a number of discouraging factors. Therefore, this study aimed to assess the uptake of HPV vaccination and associated factors among high school female students in Dessie City Administration, Northeast Ethiopia, 2023.

Methods: School-based cross-sectional study was conducted among 410 high school female students in Dessie City Administration from April 1, 2023, to May 1, 2023. Participants were selected using a simple random sampling technique. The data were collected using self-administered questionnaires. Data were entered using EPI data version 4.6 and exported to SPSS version 26 for analysis. Data were presented with frequency tables, graphs, and pie charts. To determine the factors associated with the outcome, a two-step logistic regression approach was employed. Initially, a bivariable analysis identified potential predictor variables with a p-value of less than 0.25, which were then included in a multivariable model. A p-value of less than 0.05 and an adjusted odds ratio at a 95% confidence level were used to confirm associations. In addition, the Hosmer-Lemeshow test was used to assess the model's goodness of fit.

Results: The overall uptake of the HPV vaccine among female high school students in Dessie City was 54.9% with 95% CI (50.2, 59.8). In this study finding, fathers' educational level (AOR = 5.00, 95% CI: (1.59, 15.73)), source of information (AOR = 2.08, 95% CI: (1.13, 3.83)), and having positive attitude toward HPV vaccination (AOR = 1.88, 95% CI: 1.23, 2.87) were variables that showed a significant association with uptake of HPV vaccine.

Conclusion: In this study, nearly half a percent of female high school students did not uptake the HPV vaccine. Fathers' education level, source of information, and positive attitude were positively associated with the uptake of the HPV vaccine among female high school students. Therefore, schools should provide continuous school-based training about the HPV vaccine to foster attitudinal change among female high school students.

Cervical cancer is the fourth most common cancer among women worldwide, with 660,000 new cases and 350,000 deaths reported in 2022. This disease mainly affects women in low- and lower-middle-income countries (LMICs), where 90% of cases occur. This study explored how LMICs are responding to the World Health Organization's (WHO) call to eliminate cervical cancer. It looked at cervical cancer rates, the use of human papillomavirus (HPV) vaccines, and suggested strategies to fight the disease. The study analyzed the rates of cervical cancer and deaths in LMICs, the effectiveness of HPV vaccination programs, and how well screening efforts are working. To compare data across countries, it used age-standardized incidence rates (ASIRs) and age-standardized mortality rates (ASMRs) per 100,000 women per year. In 2022, the ASIR was 25.4% in lower income countries and 16.9% in lower-middle-income countries. The ASMR was also higher in lower income countries (18.5%) compared to lower-middle-income countries (10.3%). HPV vaccine coverage remains low in many LMICs, with significant differences between the rates of first and final doses completed. By 2050, the number of new cervical cancer cases is expected to rise. Although the WHO aims to eliminate cervical cancer by achieving 90% HPV vaccination by age 15, 70% screening coverage, and 90% access to treatment, many challenges remain in LMICs. These include weak healthcare systems, poor infrastructure, and a lack of health education. Overcoming these challenges through better vaccine distribution, improved screening programs, and stronger healthcare systems is essential to eliminate cervical cancer.

Vaccination in Africa faces significant challenges due to inadequate cold chain infrastructure, particularly in regions lacking reliable electricity. Approximately 80% of prequalified vaccines require cold chain systems to maintain their potency, which is often unfeasible in remote areas. Exposure to extreme temperatures can lead to a loss of vaccine potency, making it crucial to explore alternatives. Thermostable vaccines represent a technological advancement that addresses these challenges by eliminating the need for cold chain mechanisms during transport and storage. This narrative review analyzes trends in the uptake of thermostable vaccines and their impact across Africa. A total of 10 studies were reviewed, encompassing 14 African countries, revealing critical insights into the potential of thermostable vaccines to enhance immunization coverage in settings with limited access to traditional cold chain facilities. These vaccines, which maintain their efficacy even when exposed to higher temperatures for short periods, offer a promising solution to the logistical and economic hurdles of vaccine delivery in resource-limited settings.

Background: Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is an ancient disease that continues to pose a significant threat to global public health. Although the BCG vaccine, developed in the 1920s, remains the only approved TB vaccine, it has limited efficacy, particularly against pulmonary TB in adults. The ID93/GLA-SE vaccine, a recombinant subunit vaccine, shows promise by triggering immune solid responses and could be a key solution in combating TB, particularly in the face of rising drug-resistant strains and suboptimal current vaccines. It has the potential to address the unmet need for more effective interventions against drug-resistant TB, a growing global health issue that continues to challenge existing treatment options.

Objective: To evaluate the immunogenicity and safety of ID93 + GLA-SE in BCG-vaccinated healthy adults.

Methods: A comprehensive electronic search on PubMed (Medline), ScienceDirect, EMBASE, Scopus, and Cochrane Central database was conducted from inception till August 2024 for randomized controlled trials (RCTs) with a target population of BCG-vaccinated healthy adults. This review was conducted according to (PRISMA) criteria and registered with PROSPERO (CRD42024601450). This meta-analysis used Review Manager and forest plots for visual display. The outcomes were displayed as risk ratios (RR) with a 95% confidence interval.

Results: The ID93 + GLA-SE vaccine showed strong immunogenicity, particularly in high doses, with robust IgG responses sustained up to day 421 in all studies, significantly higher than baseline, and seroconversion rates remained high through day 84. CD4 T-cell responses peaked after the third dose and remained elevated through day 421, whereas CD8 T-cell responses were minimal. Regarding adverse effects, the ID93 + GLA-SE vaccine significantly increases fatigue (RR 3.24, p = 0.005), myalgia (RR 5.82, p < 0.0001), and injection site pain (RR 4.12, p < 0.00001), compared to placebo, with consistent results across both high and low doses. However, there were no significant differences for upper respiratory tract infections, 0.83 (95% CI 0.38-1.84, p = 0.87) or 1.77 (95% CI 0.77-4.10, p = 0.18) headaches. Dose optimization remains crucial due to the higher side effect risks of increased doses.

Conclusion: The ID93 + GLA-SE vaccine shows a solid safety profile and enhances immune responses, especially IgG and CD4+ T-cell activity, which is crucial for TB defense. Higher doses improve efficacy but increase side effects, highlighting the need for dose optimization. As a potential alternative to the BCG vaccine, especially in drug-resistant TB regions, further research should refine dosage and assess long-term safety.

Background: Human papillomavirus (HPV) continues to pose a significant threat to public health, serving as the primary cause of cervical cancer. To address this issue, a vaccine has been developed to decrease the incidence of cervical cancer. However, the practice and its associated factors with the uptake of the vaccine have not been well studied in this particular region. Consequently, this study aims to evaluate the practice of HPV vaccination and its associated factors among female adolescent students in the Eastern Zone of Tigray, North Ethiopia, 2024.

Methods: A cross-sectional study design was conducted from September 2023 to January 2024 at primary schools of the Eastern Zone, Tigray, Ethiopia. Data related to HPV vaccination practice and its associated factors were collected from 634 female adolescent primary school students. The collected data were checked for completeness daily, coded, entered, and cleaned using Epinfo version 7.2.3 then exported and analyzed using SPSS version 24. Bivariate and multivariate logistic regression analyses were used to assess the association between dependent and independent variables. The corresponding variables with a p-value (p < 0.05) with a 95% confidence interval were considered statistically significant.

Result: Among the 634 participants, 61.7% received the quadrivalent Gardasil HPV vaccine. Of these, 52.1% (330/634) demonstrated good knowledge, with an adjusted odds ratio (AOR) of 1.931 (95% confidence interval (CI), 1.364-2.735) and a p-value < 0.000. Moreover, participants who had a positive attitude toward HPV vaccination, with (AOR = 1.529, 95% CI = 1.049-2.230; p-value < 0.027) and participants who expressed their agreement for taking the HPV vaccine (AOR = 1.816, 95% CI = 1.046-3.152; p-value < 0.034) were factors associated with female adolescent students' practice of the HPV vaccination.

Conclusion and recommendation: The results indicated that the majority of study participants received one dose of the HPV vaccine. The study further reveals several factors associated with HPV vaccination among female adolescent students, including a positive attitude toward the vaccine and good knowledge about its benefits. Health authorities are recommended to promote the HPV vaccine through mass media in schools, religious institutions, and healthcare facilities to increase practice among adolescent females.