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This report surveyed vaccination decisions during pregnancy based on the package inserts of vaccines approved in Japan, the USA, and Europe. Furthermore, it evaluates vaccination decision-making factors based on the characteristics of the target infections and the modality of the vaccines. Live vaccines known to cause fetal abnormalities are contraindicated for pregnant women, whereas vaccines for life-threatening infectious diseases are authorized for administration during pregnancy when the need is recognized, even for live vaccines. We compared the World Health Organization and European Medicines Agency guidelines on the development of vaccines for pregnant women and surveyed the details of the studies to collect information on SARS-CoV-2 vaccination during pregnancy. In compliance with the guidelines, for all SARS-CoV-2 vaccines, non-clinical reproductive and developmental toxicity studies and clinical trials including non-pregnant women of childbearing age were conducted prior to the vaccination of pregnant women. For all vaccines, information from registries on vaccination during pregnancy are used for post-marketing surveillance. While it is desirable to vaccinate women before pregnancy through planned immunization, whenever possible, pandemics such as H1N1 influenza and COVID-19 may require vaccination even during pregnancy. Necessary and sufficient studies for the decision of vaccination during pregnancy should be carried out promptly.

Virus-like particles (VLPs) are virus-derived structures made up of one or more different molecules with the ability to self-assemble, mimicking the form and size of a virus particle but lacking the genetic material so they are not capable of infecting the host cell. Expression and self-assembly of the viral structural proteins can take place in various living or cell-free expression systems after which the viral structures can be assembled and reconstructed. VLPs are gaining in popularity in the field of preventive medicine and to date, a wide range of VLP-based candidate vaccines have been developed for immunization against various infectious agents, the latest of which is the vaccine against SARS-CoV-2, the efficacy of which is being evaluated. VLPs are highly immunogenic and are able to elicit both the antibody- and cell-mediated immune responses by pathways different from those elicited by conventional inactivated viral vaccines. However, there are still many challenges to this surface display system that need to be addressed in the future. VLPs that are classified as subunit vaccines are subdivided into enveloped and non- enveloped subtypes both of which are discussed in this review article. VLPs have also recently received attention for their successful applications in targeted drug delivery and for use in gene therapy. The development of more effective and targeted forms of VLP by modification of the surface of the particles in such a way that they can be introduced into specific cells or tissues or increase their half-life in the host is likely to expand their use in the future. Recent advances in the production and fabrication of VLPs including the exploration of different types of expression systems for their development, as well as their applications as vaccines in the prevention of infectious diseases and cancers resulting from their interaction with, and mechanism of activation of, the humoral and cellular immune systems are discussed in this review.

Background The influenza viruses pose a threat to human health and medical services, and vaccination is an important way to prevent infection. However, the effectiveness of influenza vaccines is affected by various aspects. This study aimed to explore factors related to the immune response to influenza vaccines. Methods The study was conducted from September 2019 to September 2021, and a total of 593 volunteers were recruited from the Center for Disease Control and Prevention in 3 provinces in China. The hemagglutination inhibition assay was used to measure antibody levels. The Chi-square test, multivariable logistic regression analysis, and sum-rank test were used to analyze the factors associated with influenza vaccine immune response. Results The Chi-square test showed that seroconversion rates and response rate were associated with age group, vaccination history, chronic conditions, the frequency of colds, and region ( P  < 0.05). The multivariable logistic regression analysis showed that age was an important factor that affected participants’ seroconversion rates for A/H1N1, A/H3N2, B/Victoria, and response status (18–64 vs. ≤5: OR = 2.77, P  < 0.001; ≥65 vs. ≤5: OR = 0.38, P  = 0.01; 18–64 vs. ≤5: OR = 2.64, P  = 0.03). Vaccination history was also an affecting factor for A/H1N1, B/Victoria, and response status (yes vs. no: OR = 0.4 / 0.44 / 0.25, P  < 0.001). The frequency of colds and chronic conditions were also affecting factors for participants’ seroconversion rates and response levels to different degrees. The sum-rank test showed that the fold changes for A/H1N1, B/Victoria, and B/Yamagata were associated with age group and vaccination history ( P  < 0.01). The fold changes for A/H3N2 were associated with the frequency of colds ( P  < 0.05), and those for B/Victoria were associated with gender and chronic conditions ( P  < 0.05). Conclusions Vaccination history, age, health condition, and frequency of colds were important factors affecting the seroconversion rate of the influenza vaccine in human. There is a need for developing optimized vaccination strategies for vulnerable groups to improve the efficacy of influenza vaccines in human.

Background Numerous vaccination research experiments have been conducted on non-primate hosts to prevent or control HTLV-1 infection. Therefore, reviewing recent advancements for status assessment and strategic planning of future preventative actions to reduce HTLV-1 infection and its consequences would be essential. Methods MEDLINE, Scopus, Web of Science, and Clinicaltrials.gov were searched from each database's inception through March 27, 2022. All original articles focusing on developing an HTLV-1 vaccine candidate were included. Results A total of 47 studies were included. They used a variety of approaches to develop the HTLV-1 vaccine, including DNA-based, dendritic-cell-based, peptide/protein-based, and recombinant vaccinia virus approaches. The majority of the research that was included utilized Tax, Glycoprotein (GP), GAG, POL, REX, and HBZ as their main peptides in order to develop the vaccine. The immunization used in dendritic cell-based investigations, which were more recently published, was accomplished by an activated CD-8 T-cell response. Although there hasn't been much attention lately on this form of the vaccine, the initial attempts to develop an HTLV-1 immunization depended on recombinant vaccinia virus, and the majority of results seem positive and effective for this type of vaccine. Few studies were conducted on humans. Most of the studies were experimental studies using animal models. Adenovirus, Cytomegalovirus (CMV), vaccinia, baculovirus, hepatitis B, measles, and pox were the most commonly used vectors. Conclusions This systematic review reported recent progression in the development of HTLV-1 vaccines to identify candidates with the most promising preventive and therapeutic effects.

Objective We aimed to compare the adaptive immune response in individuals with or without prior SARS-CoV-2 infections following the administration of mRNA-based COVID-19 vaccines. Methods A total of 54 participants with ages ranging from 37 to 56 years old, consisting of 23 individuals without a history of SARS-CoV-2 infection (uninfected group) and 31 individuals with prior infection of SARS-CoV-2 (infected group) who have received two doses of mRNA SARS-CoV-2 vaccines were enrolled in this study. We measured the IFN-γ level upon administration of BNT162b2 (PF) or mRNA-1273 (MO) by QuantiFERON SARS-CoV-2. The production of neutralizing antibodies was evaluated by a surrogate virus neutralization assay, and the neutralizing capacity was assessed by a plaque reduction neutralization test (PRNT 50 ). The immune response was compared between the two groups. Results A significantly higher level of IFN-γ (p  <  0.001) and neutralization antibodies (p  <  0.001) were observed in the infected group than those in the uninfected group following the first administration of vaccines. The infected group demonstrated a significantly higher PRNT 50 titer than the uninfected group against the Wuhan strain (p < 0.0001). Still, the two groups were not significantly different against Delta (p  =  0.07) and Omicron (p  =  0.14) variants. Following the second vaccine dose, T- and B-cell levels were not significantly increased in the infected group. Conclusion A single dose of mRNA-based COVID-19 vaccines would boost immune responses in individuals who had previously contracted SARS-CoV-2.

Background Corona Virus Disease 2019 (COVID-19) mRNA vaccine effectiveness (VE) has recently declined, and reports about COVID-19 breakthrough infection have increased. We aimed to conduct a meta-analysis on population-based studies of the prevalence and incidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) breakthrough infection amongst older adults worldwide. Methods Studies from PubMed, Embase, Cochrane Library, and Web of Science were systematically screened to determine the prevalence and incidence of SARS-CoV-2 breakthrough infection in older adults from inception to November 2, 2022. Our meta-analysis included 30 studies, all published in English. Pooled estimates were calculated using a random-effect model through the inverse variance method. Publication bias was tested through funnel plots and Egger’s regression test, and sensitivity analyses were performed to confirm the robustness of the results. This research was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results Thirty publications were included in this meta-analysis (17 on prevalence, 17 on incidence, and 4 on both). The pooled prevalence of COVID-19 breakthrough infection among older adults was 7.7 per 1,000 persons (95% confidence interval [95%CI] 4.0–15.0). At the same time, the pooled incidence was 29.1 per 1000 person-years (95%CI 15.2–55.7). Conclusions This meta-analysis provides estimates of prevalence and incidence in older adults. We concluded that the prevalence and incidence of SARS-CoV-19 breakthrough infection in older people was low. The prevalence and incidence of breakthrough infection admitted to hospital, severe-critical, and deathly was significantly lower. Otherwise, there was considerable heterogeneity among estimates in this study, which should be considered when interpreting the results.

A multivalent, rapidly deployable, mucosal vaccine platform is desperately needed to prevent acquisition and transmission of respiratory infections during epidemics and pandemics. No such approved platform currently exists and virtually all under investigation use infectious viruses that have safety concerns and are not amenable for multivalent engineering. Herein, a non‐infectious biomaterial platform is presented, the bacteriophage T4 nanoparticle endowed with unique features for modular engineering, which is exploited to design dual COVID‐Flu mucosal vaccines. By leveraging T4's natural affinity to nasal mucosa, in vivo CRISPR engineering, and in vitro SpyCatcher‐SpyTag conjugation, hundreds of antigen molecules are incorporated from SARS‐CoV‐2 and influenza viruses into one nanoparticle. These include spike and hemagglutinin trimers and M2e peptides decorating the capsid while encapsulating matrix or nucleocapsid proteins inside, thereby achieving unprecedented antigen density and diversity, a pinnacle nanoparticle design. Intranasal administration of this adjuvant‐free T4‐CoV‐Flu vaccine induces remarkable mucosal immunity against both respiratory pathogens, including high‐titer neutralizing antibodies and secretory IgA, lung‐resident CD4+/CD8+ T cells, diverse memory B cells, and complete protection against SARS‐CoV‐2 and influenza challenges. Coupled with its scalability in bacterial systems, thermostability, and adjuvant‐ and needle‐free delivery, T4 presents an extraordinary platform to design potent mucosal vaccines against pandemic threats. A bacteriophage T4‐based mucosal vaccine platform is developed for dual protection against two highly transmissible respiratory diseases, COVID‐19 and flu. This adjuvant‐free vaccine incorporates multiple viral antigens into phage nanoparticle for high‐density display and intranasal delivery. The vaccine induces robust mucosal immunity and provides complete protection in mouse models, highlighting its potential as a preventative, needle‐free solution for pandemic preparedness.

Introduction It is important to identify the relationship between the COVID-19 vaccination status and the prognosis of this disease in hospitalized patients to gain a more accurate picture of their status and the effect of vaccination, as well as take necessary measures to improve their medical care. Thus, the present study was conducted to investigate the relationship between the vaccination status of hospitalized COVID-19 patients and the disease severity index in terms of clinical, imaging, and laboratory criteria. Methods This research is a descriptive-analytical cross-sectional study. the study population consisted of patients with a positive RT-PCR test for coronavirus, admitted to COVID-19 departments of teaching hospitals in Yazd, Iran, during two months in the sixth peak of COVID-19. The patients’ data comprised demographic information (age, sex, and underlying disease), clinical information (length of hospital stay, length of ICU stay, and vaccination status), disease outcome (mortality and intubation), laboratory information (ESR, CRP, and NLR), and imaging information (lung involvement percentage), and finally, the relationship between patients’ vaccination status and disease severity indices were analyzed with the chi-square test, independent t-test, and logistic regression analysis at a 95% confidence interval (CI). Findings According to research findings, the duration of hospitalization was 5.25 ± 2.34 and 6.11 ± 3.88 days in groups of patients with complete and incomplete vaccination, respectively ( P  = 0.003). The lengths of ICU stay were 6 ± 4.63 and 5.23 ± 3.73 days in both groups of patients admitted to the ICU ( P  = 0.395). Furthermore, there were significant relationships between the ICU admission rates, endotracheal intubation, mortality rate, the lung involvement score in the chest CT scan, and the NLR with the vaccination status.Multivariate regression analysis indicated that DM, IHD, NLR, CT scan score and vaccination status were related to patients’ in-hospital mortality. Conclusion Complete vaccination of COVID-19 led to a milder disease in terms of clinical, imaging, and laboratory criteria of patients and decreased the possibility of hospitalization in ICUs, intubation, and mortality in patients.

Background Outreach efforts were developed to bolster people’s access to and use of immunization services in underserved populations. However, there have been multiple outbreaks of diseases like measles in Uganda, prompting policy makers and stakeholders to ask many unanswered questions. This research study was created to uncover the discrepancies between vaccine management practices at immunization outreach sessions in rural South Western Uganda compared with existing standards. Methods The observational qualitative study, was done in 16 public health facilities across four districts of Uganda. Data were collected using in-depth interviews, facility record reviews, and observation. We assessed the vaccine management procedures before immunization session, transportation used, set up at the outreach site, management practices during the outreach session and packing of vaccines - according to World Health Organization immunization practice recommendations. The data were transcribed, coded and categories were formed and triangulated. Themes were generated based on a socio-ecologic framework to gain a better understanding of healthcare provider practices during immunization sessions. Results Fifty-one individuals were interviewed; four Assistant District Health Officers, four cold chain technicians, 15 focal persons for the Expanded Program on Immunization, and 28 health care providers. The respondents’ mean age was 35, 43 (84.3%) were females and 24 (47.1%) had a diploma. 11 (69%) outreaches were conducted at a distance of 5-12 km from the health facility and 7 (44%) were conducted in a building. For 8 outreaches (50%) health facility staff did not check the vaccine vial monitor status before the outreach while 12(75%) did not keep the vaccine hard lid cover closed during the sessions. The main areas of concern were insufficient vaccine integrity monitoring, improper handling and storage practices, deficient documentation, and inadequate vaccine transportation. These were similar across immunization outreach sites regardless of vaccine preventable disease outbreaks occurrences. The majority of these gaps were located at the individual level but were enabled by policy/environmental factors. Conclusions There are poor vaccine management procedures during outreach sessions contrary to established guidelines. Specific tactics to tackle knowledge deficiencies, health worker attitude, and fewer equipment shortages could improve compliance to guidelines.

Multi-epitope polypeptide vaccines, a fusion protein, often have a string-of-beads system composed of various specific peptide epitopes, potential adjuvants, and linkers. When choosing the sequence of various segments and linkers, many alternatives are available. These variables can influence the vaccine’s effectiveness through their effects on physicochemical properties and polypeptide tertiary structure. The most conserved antigens were discovered using BLASTn. To forecast the proteins’ subcellular distribution, PSORTb 3.0.2 was used. Vaxign was used for the preliminary screening and antigenicity assessment. Protein solubility was also predicted using the ccSOL omics. Using PRED-TMBB, it was anticipated that the protein would localize across membranes. The IEDB and BepiPred-2.0 databases were used to predict the immunogenicity of B cell epitopes. A multi-epitope construct was developed and analyzed to evaluate. Twenty epitopes from A. baumannii ’s outer membrane protein (omp) were included in the vaccination. TLR4 agonist explosibility was investigated. The physicochemical characteristics, secondary and tertiary structures, and B-cell epitopes of vaccine constructs were assessed. Additionally, docking and MD experiments were used to examine the relationship between TLR4 and its agonist. Thirteen antigens were discovered, and eight of the 13 chosen proteins were predicted to be surface proteins. The 34 kDa outer membrane protein, Omp38, Omp W, CarO, putative porin, OmpA, were chosen as having the right antigenicity (≥0.5). FhuE and CdiA were eliminated from further study because of their low antigenicity. The vaccine design was developed by combining the most effective 10 B-cell and 10 MHC-I/MHCII combined coverage epitopes. The molecular formula of the vaccine was determined to be C1718H2615N507O630S17. The vaccine form has a molecular weight of 40,996.70 Da and 47 negatively charged residues (Asp + Glu), whereas 28 positively charged residues (Arg + Lys). The estimated half-life was 7.2 hours (mammalian reticulocytes, in vitro), > 20 hours ( yeast , in vivo) and > 10 hours ( Escherichia coli , in vivo) for the vaccine. The multi-epitope vaccine insertion is carried via the expression vector pcDNA3.1 (+). The multi-epitope vaccine may stimulate humoral and cellular immune responses, according to our findings, and it may be a candidate for an A. baumannii vaccine.