Vaccine Safety Research Articles

Phase I clinical trial to assess the safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine

Phase I clinical trial to assess the safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine

Virus-like Particles vaccine based on co-expression of G5 Porcine rotavirus VP2-VP6-VP7 induces a powerful immune protective response in mice

Porcine rotavirus (PoRV), a member of the Reoviridae family, constitutes a principal etiological agent of acute diarrhea in piglets younger than eight weeks of age, and it is associated with considerable morbidity and mortality within the swine industry. The G5 genotype rotavirus strain currently predominates in circulation. To develop a safe and effective porcine rotavirus vaccine, we generated an insect cell-baculovirus expression system, and successfully expressed these three viral proteins and assembled them into virus-like particles (VLPs) co-displaying VP2, VP6, and VP7. Transmission electron microscopy (TEM) analysis revealed that the VP2-VP6-VP7 VLPs exhibited a "wheeled" morphology resembling that of native rotavirus particles, with an estimated diameter of approximately 65nm. To evaluate the immunogenicity and protective efficacy of these VP2-VP6-VP7 VLPs, we immunized BALB/C mice with four escalating doses of the VLPs, ranging from 5 to 40μg of VLP protein per dose. ELISA-based assessments of PoRV-specific antibodies and T cell cytokines, including IL-4, IL-2, and IFN-γ, demonstrate that immunization with VP2-VP6-VP7 VLPs can effectively elicit both humoral and cellular immune responses in mice, resulting in a notable induction of neutralizing antibodies. On days 4, 6, 8, and 10 post-infection (dpi), the VLP-vaccinated group exhibited significantly reduced levels of PoRV RNA copy numbers when compared to the PBS controls. Histological examination of the duodenum, ileum, and kidneys revealed that VP2-VP6-VP7 VLPs provided effective protection against PoRV induced intestinal injury. Collectively, these findings indicate that the VLPs generated in this study possess strong immunogenicity and suggest the considerable promise of the VLP-based vaccine candidate in the prevention and containment of Porcine Rotavirus infections.

The Prospects of Phytomedicines and Nanomedicines to Treat Leishmaniasis: A Comprehensive Review.

The global shift in lifestyle has prompted health agencies to redirect their focus from poverty-related diseases to the emergence of lifestyle diseases prevalent in privileged regions. As a result, these diseases have been labeled as "neglected diseases," receiving limited research attention, funding, and resources. Neglected Tropical Diseases (NTDs) encompass a diverse group of vector-borne protozoal diseases that are prevalent in tropical areas worldwide. Among these NTDs is leishmaniasis, a disease that affects populations globally and manifests as skin abnormalities, internal organ involvement, and mucous-related abnormalities. Due to the lack of effective and safe medicines and vaccines, it is crucial to explore alternative resources. Phytomedicine, which comprises therapeutic herbal constituents with anti-leishmanial properties, holds promise but is limited by its poor physicochemical properties. The emerging field of nanomedicine has shown remarkable potential in revitalizing the anti-leishmanial efficacy of these phytoconstituents. In this investigation, we aim to highlight and discuss key plant constituents in combination with nanotechnology that have been explored in the fight against leishmaniasis.

AI chatbots and political learning

ABSTRACT We preregistered and experimentally tested six hypotheses assessing AI chatbot effects on political learning. We randomly assigned subjects to the AI chatbot ChatGPT, Google Search, or a control group with no stimulus or outside assistance in two nationally representative survey experiments on U.S. crime rates and vaccine safety. Subjects using AI chatbots learn more than those with no Internet resources and are confident in what they learn. However, none of these attributes from AI usage were substantively different from those using Google searches in both samples and topics. Directly engaging with ChatGPT increases subjects’ comprehension of their researched content compared to Google. These findings suggest that AI chatbots help promote political learning but are not necessarily more impactful than traditional Internet searches. The impact of AI evolution on shaping political discourse and public knowledge warrants further exploration.

Immunogenicity and safety of DTPW-HEPB-HIB (PRP-T) vaccine (Pentavac) in infants aged 2–7 months: a post marketing phase 4 clinical trial study

Background.Vaccines play a critical role in safeguarding public health, particularly for children. It is imperative to proactively address safety concerns to uphold trust in their effectiveness and safety. Skepticism surrounding vaccines can have significant adverse effects on the overall well-being of the entire population, potentially leading to individuals opting out of vital vaccinations, thereby posing risks to public health. Thus, ensuring confidence in vaccine safety remains paramount.Materials and methods.This phase four clinical trial was conducted as a post-marketing study (PMS) on 2 to 7 month old healthy infants (N = 539) to evaluate immunity and safety of Indian pentavalent vaccine containing Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenza type b [DTPW-HEP B-HIB (PRP-T)/PENTAVAC] in four different centers at Tehran province. Blood samples were collected from eligible infants before receiving the vaccine (2 months of age) and 1 month after the third dose (7 months of age) to determine antibodies against all antigens in the pentavalent vaccine using ELISA.Results.The results indicated that the immune responses demonstrated seroprotection and protective antibody levels after three doses of the vaccine for Haemophilus influenza b, diphtheria, tetanus, hepatitis B virus andBordetella pertussiswere 99.1%, 98.7%, 99.8%, 99.4% and 69.6%, respectively. Statistical analysis showed that the P-value for all vaccine components was similar (P 0.001). The five most common side effects reported were mild fever (10%), erythema at the vaccination site (9.1%), inflammation (4.3%), pain at the vaccination site (3.3%), and restlessness (2.6%).Conclusion.This study’s findings demonstrated a significant increase in antibody levels against all five vaccine components. In light of these results, it can be concluded that the Pentavalent vaccine is not only effective in enhancing immunity against multiple diseases but also presents minimal risk of side effects in the study population. These findings contribute to the body of evidence supporting the safety and efficacy of vaccines, underscoring their crucial role in protecting public health.

Evaluation of Interfering RNA Efficacy in Treating Hepatitis B: Is It Promising?

Background: Despite an existing safe and effective vaccine for hepatitis B virus (HBV), it is still a major public health concern. Nowadays, several drugs are used to treat chronic hepatitis B; however, full healing remains controversial. The viral covalently closed circular DNA (cccDNA) formed by HBV forms a major challenge in its treatment, as does the ability of HBV to integrate itself into the host genome, which enables infection reactivation. Interfering RNA (RNAi) is a gene-silencing post-transcriptional mechanism which forms as a promising alternative to treat chronic hepatitis B. The aim of the present review is to assess the evolution of hepatitis B treatment approaches based on using RNA interference. Methods: Data published between 2016 and 2023 in scientific databases (PubMed, PMC, LILACS, and Bireme) were assessed. Results: In total, 76,949 articles were initially identified and quality-checked, and 226 eligible reports were analyzed in depth. The main genomic targets, delivery systems, and major HBV therapy innovations are discussed in this review. This review reinforces the therapeutic potential of RNAi and identifies the need for conducting further studies to fill the remaining gaps between bench and clinical practice.

Understanding the barriers and enablers to participation in vaccine trials in a pregnant population from diverse ethnic background in an inner-city UK hospital.

Vaccination during pregnancy is an important healthcare intervention for safeguarding the health of the mother and their infants. Ethnic disparities in recruitment to vaccine research studies during pregnancy potentially contribute to health inequalities. The aim of the current study was to explore the barriers and enablers influencing the willingness of pregnant women from ethnic minority backgrounds to participate in vaccine research studies. Semi-structured qualitative online interviews were conducted with 23 pregnant women from diverse ethnic backgrounds in the UK. Interviews were transcribed verbatim, and thematically analysed. Our findings suggest that participants perceived vaccines and vaccine research, in principle, to be beneficial to the individual and to society, and understood the value of vaccination in mitigating severity of disease and protecting the health of mothers and their infants. Apprehension over the safety of vaccination in pregnancy was common and reduced willingness to participate. For those that decided to participate in vaccine trials in pregnancy, this was seen as an act of solidarity, a way to contribute to a collective responsibility for the public health of the community. Personal and community connections and representation-seeing people from their own communities represented in in the recruitment process shapped decisions about vaccine trial participating. Trust and mistrust in health systems, shaped by past experiences of interacting with healthcare professionals were likely to inform whether they would consider participating. Practical considerations such as excessive time commitments related to study procedures, travel and organising childcare were barrier to participation. The level of invasiveness of trial procedures were also a concern, although increased monitoring during the trial was seen as a potential benefit, mitigating some safety concerns. Our study reinforcing previously identified barriers to vaccine participation among pregnant women from diverse ethnic communities. This study underlines the need to develop tailored interventions that focus on fostering trust with the aid of community engagement to understand cultural contexts, establishing authentic representation, and address practical considerations, to contribute to enhancing vaccine trial participation in pregnancy in those from diverse ethnic communities.

Person-Centered Web-Based Mobile Health System (Symptoms) for Reporting Symptoms in COVID-19 Vaccinated Individuals: Observational Study of System, Users, and Symptoms.

The full spectrum of side effects from COVID-19 vaccinations and infections, including milder symptoms or health effects that do not lead to health care visits, remains unknown. Person-centered self-reporting of symptoms may offer a solution. Monitoring patient-reported outcomes over time will vary in importance for different patients. Individuals have unique needs and preferences, in terms of both communication methods and how the collected information is used to support care. This study aims to describe how Symptoms, a system for person-centered self-reporting of symptoms and health-related quality of life, was utilized in investigating COVID-19 vaccine side effects. We illustrate this by presenting data from the Symptoms system in newly vaccinated individuals from the RECOVAC (Register-based large-scale national population study to monitor COVID-19 vaccination effectiveness and safety) study. During the COVID-19 pandemic, newly vaccinated individuals were identified as the ideal population to query for milder symptoms related to COVID-19 vaccinations and infections. To this end, we used posters in observation areas at 150 vaccination sites across the Västra Götaland region of Sweden, inviting newly vaccinated individuals to use a novel digital system, Symptoms. In the Symptoms system, users can track their symptoms, functioning, and quality of life as often as they wish, using evidence-based patient-reported outcome measures and short numeric rating scales. These scales cover a prespecified list of symptoms based on common COVID-19 symptoms and previously reported vaccine side effects. Participants could also use numeric rating scales for self-defined symptoms if their symptom was not included on the prespecified list. A total of 731 people created user accounts and consented to share data for research between July 21, 2021, and September 27, 2022. The majority of users were female (444/731, 60.7%), with a median age of 38 (IQR 30-47) years. Most participants (498/702, 70.9%) did not report any of the comorbidities included in the questionnaire. Of the 731 participants, 563 (77.0%) reported experiencing 1 or more symptoms. The most common symptom was pain at the injection site (486/563, 86.3%), followed by fatigue (181/563, 32.1%) and headache (169/563, 30.0%). In total, 143 unique symptoms were reported. Of these, 29 were from the prespecified list, while the remaining 114 (79.7%) were self-defined entries in the symptom field. This suggests that the flexibility of the self-directed system-allowing individuals to decide which symptoms they consider worth tracking-may be an important feature. Self-reported symptoms in the Symptoms system appeared to align with previously observed post-COVID-19 vaccination symptoms. The system was relatively easy to use and successfully captured broad, longitudinal data. Its person-centered and self-directed design seemed crucial in capturing the full burden of symptoms experienced by users.

CAUSES OF VACCINATION RESISTANCE AND THE ROLE OF NURSING: NARRATIVE REVIEW

Several questions regarding the safety and efficacy of vaccines have generated resistance to vaccination and brought instability to the health of the population. Objective: to evaluate the causes of resistance to vaccination and explain how nurses can solve this problem. Method: Narrative review study. Results: The widespread presence of misinformation among the population about vaccination highlights the importance of proactive action by nurses to dispel myths related to vaccination. Conclusion: Nurses should engage in educational practices, increasing awareness among the population.

Correlation between vaccine hesitancy, vaccine reliability and perceptions of infectious diseases

Abstract Background Vaccine hesitancy is a delay in vaccine acceptance or refusal despite the availability of vaccination services. In recent years, the rise in vaccine hesitancy has attracted attention. This study aimed to evaluate the perception of vaccine hesitancy, vaccine safety, and infectious diseases among parents. Methods This cross-sectional study was conducted with 503 parents who applied to the pediatrics outpatient clinic of a university hospital. The questionnaire used in the study included questions on sociodemographic characteristics, factors related to vaccine hesitancy, The Vaccine Hesitancy Scale (VAS), the Vaccine Safety Scale (VSS), and the Perception Scale for Infectious Diseases (PPSID). Multivariate Linear Regression Analysis was used to find the variables associated with vaccine hesitancy. Results The mean age of the parents was 37.6±7.6 years. Parents’ scores on the ATS ranged from 17-85, with a mean score of 20.1±6.6 points. A moderate negative correlation was found between parents’ VAS and VSS scores, and between VAS and PPSID scores (r=-0.412, p < 0.001; r=-0.409, p < 0.001, respectively). According to the multivariate linear regression analysis the variables found to be associated with vaccine hesitancy, income status, maternal education level, child’s age group, having information about childhood vaccination schedule, child’s immunization status, the necessity of childhood vaccines, having sufficient information about the safety of vaccines, vaccine safety level, and infectious disease perception level were found to be significant predictors of vaccine hesitancy (F: 12,844, p ≤ 0.001, R2: 0.334). Conclusions This study determined that vaccine hesitancy was higher in families with lower income, who have not completed the schedule nor been vaccinated, doubt the necessity of vaccines to prevent infectious diseases, lack of knowledge about the reliability of vaccines, and whose children are still in primary school. Key messages • Health professionals have a critical role in reducing vaccine hesitancy. • It would be appropriate to plan face-to-face or online programs with parents.

The knowledge, attitude and practice of cardiologists versus other specialists about the safety and efficacy of influenza vaccination in patients with cardiovascular diseases

Abstract Background Influenza vaccination has been shown to reduce the occurrence of cardiovascular events, both in the general population and especially in individuals with cardiovascular disease. However, the extent to which cardiologists and other physicians support and prescribe influenza vaccination for patients with cardiovascular diseases is not known. Purpose To explore cardiologists' and other specialists' opinions on the safety and efficacy of influenza vaccination in preventing cardiovascular events. Methods From September 2023 to February 2024, a survey was conducted among physicians of any specialty, following the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). The survey was available in 5 languages. Participants' opinions were assessed using Likert-type scales. Non-probabilistic convenience sampling was employed, and duplicated responses were prevented using the SurveyMonkey® platform that identifies duplicated IP addresses. Results A total of 2550 physicians from 44 countries answered the survey; the mean age was 46.1±13.1 years, 46.4% were women, and 17.1% were in training. Among respondents 43.6% were cardiologists. While 91.8% of participants considered the influenza vaccine to be very safe, and 90.6% believed that adverse effects of this intervention were rare, a significant proportion did not consider Influenza vaccine to be very beneficial in reducing acute myocardial infarction (54.4% for cardiologists vs 59.3% for other specialists, p=0.013) or stroke (62.2% for cardiologists vs 64.9% for other specialists, p=0.167). summarizes the participants’ opinions regarding the benefits and risks of influenza vaccination. Regarding potential barriers to achieving higher vaccination rates among patients with cardiovascular disease, cardiologists' opinions were similar to those of other specialists (Table 2). Patient beliefs and patients’ fear of vaccine-related adverse effects were identified as major barriers by both cardiologists and other specialists. Only 19.0% of participants reported having some type of checklist system to remind them to recommend the vaccine to their patients. While 73.0% of participants found this topic highly relevant to their daily clinical practice, with no differences between groups (p=0.178), a notable proportion, comprising 48.5% of cardiologists and 47.1% of other specialists, expressed the necessity for additional training to address the risk-benefit ratio of influenza vaccination with their patients (p=0.485). Conclusion Our data suggest that cardiologists and other specialists view the influenza vaccine as safe with a low rate of adverse effects, both in the general population and in individuals with cardiovascular disease. However, a significant proportion of them are unaware of the vaccination's benefit in reducing cardiovascular events. Additionally, about half of the surveyed professionals expressed a need for further education to discuss the benefits of vaccination with their patients.

The Scourge of measles

Abstract Once considered a disease of the past, the resurgence of measles in England has garnered significant attention in recent weeks and months. The uptake of routine childhood vaccines including the measles, mumps and rubella (MMR) vaccine is the lowest it has been in a decade and is well below the 95% uptake needed to protect the population and prevent outbreaks. This is giving this serious disease a chance to get a foothold in our communities. From having never seen a case of measles in their life time doctors in England are now notifying cases of measles based on clinical suspicion. Since October, we have seen a rapid increase in both measles cases and outbreaks of measles across England (the total number of cases confirmed since October 2023 to date is 1109) and it has been declared a national incident. The abstract highlights the consequences of vaccine hesitancy, illustrated by case studies of outbreaks of measles among susceptible populations such as schools and prisons and the steps being taken to control the spread. Social media misinformation, distrust in healthcare authorities, and concerns over vaccine safety are some of the factors shaping parental attitudes towards MMR vaccination. In response to these challenges, the abstract underscores the importance of targeted interventions aimed at addressing vaccine hesitancy, such as community engagement initiatives, tailored communication strategies, and healthcare provider training. By emphasizing the critical role of MMR vaccination in preventing measles resurgence, this abstract advocates for a collaborative approach involving healthcare stakeholders, policymakers, and the public to combat to combat this preventable yet persistent threat to public health.

Safety of COVID-19 vaccines regarding cardiovascular events: a systematic review and meta-analysis

Abstract Background Since the outbreak of COVID-19, extensive vaccination strategies have almost excelled in reducing the mortality and severity of COVID-19 infection; however, although there are several authorized vaccines thus far, vaccine hesitancy has risen among various populations. Cardiovascular adverse events have been among the highly reported adverse events of the vaccines. Herein, we aimed to systematically assess the studies that reported the safety of COVID-19 outcomes regarding cardiovascular outcomes. Methods Three online databases were comprehensively searched, including PubMed, Scopus, and Embase. Relevant observational/interventional studies and case reports/series were included. Study characteristics, demographic features of the populations, vaccine type and dosage, and outcomes of interest were extracted. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to compare the groups vaccinated and those that have not. Results From the 2960 initial searched records, 21 observational/interventional studies, and 110 case reports/series were included. Meta-analysis revealed that there is no difference between vaccinated and non-vaccinated regarding all new-onset cardiac disorders (RR 1.14, 95% CI 0.71 to 1.85, p-value=0.59). On the other hand, vaccinated patients had a higher risk of myopericarditis, compared to the general population by 74% (RR 1.74, 95% CI 1.56 to 1.94, p-value <0.01). There was no difference between the groups in terms of risk of myocardial infarction. Among 219 individuals reported in case reports and series, 193 were diagnosed with myocarditis and pericarditis. Notably, 95.34% of these patients were vaccinated with mRNA-based vaccines. Conclusion This systematic review and meta-analysis implied that there is no increase in overall new-onset cardiac adverse events, while there might be an increased risk of myopericarditis based on some studies’ findings. This highlights that since there is no added cardiovascular risk associated with COVID-19 vaccination, all individuals are encouraged to get vaccinated.Forest plots for meta-analyses

Global malaria vaccine research and community perception in Africa: a systematic review

Abstract Background Malaria vaccine is one of the critical areas in tropical health research, considering the success recorded in other vaccine-preventable diseases. This review provides an overview of global malaria vaccine research and systematically reviews community perception of the vaccine in Africa. Methods A validated search was conducted to identify scientific literature on malaria vaccines in the Scopus database from 2005. Bibliometric indicators explored include publication/citation indices over time and the overall research themes using VOSviewer. A further in-depth search was undertaken in five databases to identify studies on community perception of malaria vaccine in Africa. Studies were screened, quality appraised, and narratively synthesized. Results 6457 malaria-vaccine-related documents were found in 160 journals/sources from 189 countries/territories. There were 214,323 total citations, with 33.2 average citations per document and 167 documents’ h-index. The United States, United Kingdom and Australia combined produced more than 60% of the publication output. Six themes emerged from the global malaria vaccine research: Merozoite surface protein, characterization, trials, infant/children, traveler, and research/review. Twenty studies (n = 20) met the inclusion criteria for the systematic review. Overall perceptions of malaria vaccines varied in African communities (26.2-88.2%), in addition to higher willingness to accept the vaccines (32.3%-96.0%), poor knowledge/awareness (11%-60%) and misconceptions (19.2%-20.9%). Other issues identified include vaccine availability and logistics. Conclusions Malaria vaccine research and citations have increased considerably, mainly targeting vaccine development and safety/efficacy in Africa. African communities’ perceptions of the vaccine varied, with most of the population willing to accept the vaccine. Key messages • An increase in number of malaria vaccine research targeting vaccine development, and safety and efficacy in Africa. • Varried malaria vaccine perception in Africa, including willingness to accept the vaccine, awareness, misconceptions, availability and logistics.

Knowledge, Attitudes and Behaviors of Healthcare Workers Working in Malatya Towards COVID-19 Vaccines

Abstract Background The rapid production of vaccines and the introduction of new vaccine technologies have raised concerns among some individuals regarding anti-vaccination, while others have expressed worries about vaccines. Given that healthcare professionals’ recommendations significantly influence people’s vaccination decisions, this study aimed to examine the knowledge, attitudes, and behaviors of healthcare professionals working in family health centers towards COVID-19 vaccines. Methods Questionnaires for this descriptive cross-sectional study were administered between February and April 2022. The population comprised 408 health workers employed in family health centers in Malatya, with 292 individuals completing the study. The questionnaire included questions about sociodemographic, COVID-19, COVID-19 vaccines and the COVID-19 Fear Scale. Results Although 97.3% of the research group reported having received the COVID-19 vaccination, 47.9% expressed concerns about these vaccines. The median score of the COVID-19 Fear Scale was 15 (7.00-35.00). 86.6% of the participants indicated that they recommended COVID-19 vaccines. 16.4% of the participants agreed with the statement ‘there are no studies proving the safety of vaccines,’ and 49% agreed that ‘vaccines pass through clinical trials quickly and are put on the market’. Those who did not recommend COVID-19 vaccines, those who agreed with the statement ‘there are no studies proving the safety of vaccines’ and those who agreed with the statement ‘vaccines pass through clinical trials quickly and are put on the market’ were concerned about COVID-19 vaccines with their level of concern significantly higher (p < 0.05). Conclusions Almost all members of the research group had received the COVID-19 vaccine, yet almost half of them expressed concerns about vaccines. Those who do not recommend vaccines, those who believe they are released quickly, and those who have safety concerns are more likely to be concerned. Key messages • Identify the reasons for health workers’ concerns about vaccines and provide remedial interventions for concerns that may arise regarding other vaccines. • It should be ensured that healthcare professionals, who are expected to be role models for society in terms of immunization, possess scientific and up-to-date knowledge on vaccines.

Surveillance for adverse events following immunization in Hebei Province, China, 2018-2020

ABSTRACT The aim of this study was to analyze the incidence and characteristics of adverse events following immunization (AEFI) with post-licensure vaccines used in Hebei province from 2018 to 2020 and to evaluate the safety of vaccines. All information of AEFI was gained from national adverse event following immunization surveillance system (NAEFISS) in Hebei Province from 2018 to 2020. Descriptive epidemiology method was used to analyze the data about AEFI in Hebei province. Reporting rates of AEFI were calculated by sex, age, city, categories of AEFI, severity of AEFI, reaction categories, etc. A total of 35,999 AEFI were reported through NAEFISS, and the average annual rate was 47.64/100,000 doses. The reporting rates of common adverse reactions and rare adverse reactions were 46.37/100,000 doses and 1.05/100,000 doses. The male-to-female ratio was 1.26:1. Most of the AEFI were concentrated in the ≤1 year age group and were reported in the second quarter and third quarter. The majority of AEFI were reported to be recovered or improved, and about 62% of the AEFI occurred within 24 hours after vaccination. Vaccines associated with the highest reporting rate of AEFI were diphtheria, tetanus and acellular pertussis combined vaccine (DTaP, 170.45/100,000 doses). The reporting rate of allergic rash was found to be the highest in the adverse reactions (0.29/100,000 doses). The majority of AEFI cases were common adverse reactions, while serious rare adverse reactions caused by vaccines were extremely uncommon, and all vaccines used in Hebei Province were safe.

The Impact of COVID-19 Vaccination and Infection on the Exacerbation of Myasthenia Gravis

Objectives: Myasthenia Gravis (MG) is an autoimmune disorder that can exacerbate for various reasons, including vaccination and infection. This study aimed to investigate the safety of COVID-19 vaccines for MG patients, factors influencing MG exacerbation after COVID-19 infection (MECI), the course and prognosis of MECI, and the impact of COVID-19 vaccine on infected MG patients. Methods: Patients were enrolled from the MG database in the Department of Neurology, Xuanwu Hospital, Capital Medical University. Two questionnaires were administered to collect data concerning COVID-19 vaccination (questionnaire 1, Q1) and infection (questionnaire 2, Q2) during two distinct periods. MG exacerbation was defined as an increase of at least two points in the MG activity of daily living (MG-ADL) score. COVID-19 severity was categorized as “hospitalization” or “home management”; Results: During the first data-collecting period, our database registered 1013 adult patients: 273 (26.9%) had received COVID-19 vaccinations and completed Q1, and 8 (2.9%) experienced MG exacerbation after vaccination. During the second data-collecting period, among the newly registered patients, 366 patients completed Q2. Of these, 244 were infected, with 39 (16.0%) experiencing MECI and 21 (8.6%) requiring hospitalization. Multivariate analysis showed that generalized myasthenia gravis was associated with MECI (OR 3.354, 95% CI: 1.423–7.908, p = 0.006). Among the 244 infected patients, 143 had received COVID-19 vaccinations, including 14 who received their booster dose within 6 months before COVID-19 and 129 who were vaccinated more than 6 months before COVID-19. The remaining 101 were unvaccinated. No significant associations were found between COVID-19 vaccination and COVID-19 severity (p = 0.292) or MECI incidence (p = 0.478); Conclusions: COVID-19 vaccines were found to be safe for MG patients in stable condition. Patients with gMG were more susceptible to experiencing MECI. No significant impact of the vaccine on COVID-19 severity or MECI incidence was observed.

Immunogenicity and Safety of the Recombinant Adjuvanted Herpes Zoster Vaccine in Patients with Chronic Lymphocytic Leukemia and Multiple Myeloma

Background/objectives: Patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) are susceptible to viral infections, including varicella-zoster virus (VZV) reactivation due to both disease-related and treatment-induced immunosuppression. The recombinant adjuvanted herpes zoster vaccine (RZV) has shown high efficacy in immunocompetent adults, but immunogenicity data in CLL and MM patients are limited. This study evaluates the immunogenicity and safety of RZV in this population. Methods: Patients with CLL and MM vaccinated with RZV (administered in two doses at least one month apart) were included in the study. Pre- and post-vaccination anti-VZV IgM and IgG antibody levels were measured to assess immunogenicity, and adverse events (AEs) were captured for safety evaluation. Results: Seventy-eight patients received both vaccine doses, and 71 had post-vaccination samples. Most of the patients were IgM seronegative and IgG seropositive before vaccination. Pre-vaccination IgG levels were higher in CLL patients compared to MM patients (p = 0.001), while post-vaccination IgG levels significantly increased in both CLL (p < 0.0001) and MM (p < 0.0001) patients. In actively treated CLL patients, pre-vaccination IgG levels were significantly lower than in not actively treated patients (p = 0.002). Post-vaccination IgG levels were lower in MM patients receiving antiviral prophylaxis concurrently with the vaccination (p = 0.013). AEs were reported in 49.4% of patients after the first dose and 48.7% after the second dose, mostly mild (local or low-grade systemic). One case of immune thrombocytopenia was noted. Conclusions: RZV demonstrated strong immunogenicity and acceptable safety in CLL and MM patients, significantly boosting IgG levels, even in actively treated or heavily pretreated patients.

Long-term Immunity of a Microneedle Array Patch of SARS-CoV-2 S1 Protein Subunit Vaccine Irradiated by Gamma Rays in Mice.

COVID-19 vaccines effectively prevent symptomatic infection and severe disease, including hospitalization and death. However, unequal vaccine distribution during the pandemic, especially in low- and middle-income countries, has led to the emergence of vaccine-resistant strains. This underscores the need for alternative, safe, and thermostable vaccine platforms, such as dissolved microneedle array patches (MAP) delivering a subunit vaccine, which eliminate the need for cold chain and trained healthcare personnel. This study demonstrates that the SARS-CoV-2 S1 monomer with RS09, a TLR-4 agonist peptide, serves as an optimal protein subunit immunogen. This combination stimulates a stronger S1-specific immune response, resulting in binding to the membrane-bound spike on the cell surface and ACE2-binding inhibition, compared to the monomer S1 alone or trimer S1, regardless of RS09. MAP delivery of the rS1RS09 subunit vaccine elicited higher and longer-lasting immunity compared to conventional intramuscular injection. S1-specific IgG levels remained significantly elevated for up to 70 weeks post-administration. Additionally, different doses of 5, 15, and 45 μ g of MAP vaccines induced robust and sustained Th2-prevalent immune responses, suggesting a dose-sparing effect and inducing significantly high neutralizing antibodies against the Wuhan, Delta, and Omicron variants at 15 and 45 μ g dose. Moreover, gamma irradiation as a terminal sterilization method did not significantly affect immunogenicity, with irradiated vaccines maintaining comparable efficacy to non-irradiated ones. The stability of MAP vaccines was evaluated after long-term storage at room temperature and refrigeration for 19 months, showing minimal protein degradation. Further, after an additional one-month of storage at elevated temperature (42°C), rS1RS09 in both non-irradiated and irradiated MAP degraded less than 3%, while the liquid subunit vaccine degraded over 23%. Overall, these results indicate that gamma irradiation sterilized MAP-rS1RS09 vaccines maintain stability during extended storage without refrigeration, supporting their potential for mass production and widespread use in global vaccination efforts.

Behaviorally informed digital campaigns and their association with social media engagement and COVID-19 vaccine uptake in Belize

BackgroundIncreasing vaccination coverage was key to curbing the COVID-19 pandemic globally. However, lack of trust in the vaccine and fear of side effects in regions like the Caribbean resulted in a low uptake despite enough vaccine supply.MethodsWe conducted two correlational analyses and one experiment between five sequential behaviorally informed Facebook campaigns, social media performance outcomes, and district-level vaccination data. First, we ran multivariate linear regression models to estimate the mean differences between the campaigns in (i) social media performance (“Clicks” and “Engagement”) and (ii) COVID-19 vaccination uptake at the district level. “Clicks” were measured by the number of people who clicked on the respective Facebook advert and visited the official vaccination site. “Engagements” were the number of people interacting with the advert through likes and emojis. Second, we took advantage of the experimental design during one of the campaigns to analyze the differential effect of messages conveying information about the number of people reporting vaccination side effects using words (“Few”/ “Majority) and numbers (“3 out of 100 “) on social media performance.ResultsThe correlational analysis showed that the number of “Clicks” and “Engagement” was similar among campaigns, except for the campaign focusing on vaccines’ effectiveness, which had 14.65 less clicks and 19.52 less engagements per advert (including controls and district-fixed effects) compared to the base “It’s safe” campaign. Vaccination rates were highest at times coinciding with campaigns focusing on vaccination safety and effectiveness. Our experimental results showed that informational messages related to side effects that were framed using words (“Majority did not report discomfort”/ “Few persons reported discomfort”) were better at generating “Clicks” compared to those using numbers (“3 out of 100 reported discomforts”).ConclusionsFacebook adverts highlighting vaccine safety had a similar level of social media performance as other campaigns, except for adverts focusing on vaccine efficacy, which performed worse. Communicating side-effect information with words instead of numbers can expand social media interest in low-uptake regions like the Caribbean. Our results serve as preliminary evidence for public health officials to encourage vaccine uptake in high-hesitancy contexts.