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Vaccines
Special Issues
Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety
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Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Vaccine Advancement, Efficacy and Safety".

Deadline for manuscript submissions: 31 January 2027 | Viewed by 19543

Special Issue Editor

Dr. Chloé Dimeglio

E-Mail Website
Guest Editor
Virology Laboratory, Toulouse University Hospital, 31300 Toulouse, France
Interests: SARS-CoV-2; vaccines; natural infection; variant; immunity
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Vaccines are a cornerstone of public health, offering protection against infectious diseases and contributing to global health security. This Special Issue aims to provide a comprehensive overview of the latest advancements in vaccine epidemiology, immunogenicity, effectiveness and safety, fostering collaboration among researchers, healthcare professionals and policymakers. By bringing together diverse perspectives and studies, we seek to enhance our understanding of vaccine performance across different populations and settings, ultimately improving vaccination outcomes. We invite submissions that explore a range of themes, including but not limited to the following:

  • Epidemiological Studies: Investigations into vaccine coverage, distribution and impact on disease incidence.
  • Immunogenicity Assessments: Research on immune responses elicited by various vaccines in different demographics.
  • Effectiveness Evaluations: Studies measuring real-world vaccine effectiveness and factors influencing outcomes.
  • Safety Profiles: Evaluations of adverse events and long-term safety data associated with vaccines.
  • Novel Vaccine Technologies: Innovations in vaccine development and delivery mechanisms.
  • Policy and Implementation Research: Analysis of vaccination programs and strategies for increasing uptake.

Dr. Chloé Dimeglio
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Vaccines is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • vaccine epidemiology
  • immune response
  • immunogenicity
  • vaccine effectiveness
  • safety
  • infectious diseases
  • public health
  • vaccine development
  • immunization strategies

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Published Papers (6 papers)

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Research

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13 pages, 468 KB  
Article
Safety and Immunogenicity of Single-Dose of Adsorbed Tetanus Vaccine in Adults Aged 18–44 Years: Randomized, Double-Blind, Positive-Controlled Phase I/III Clinical Trial
by Zhiqiang Xie, Liyong Yuan, Yaping Qiao, Wangyang You, Yurong Li, Taotao Zhu, Wei Zhang, Lili Huang, Jiebing Tan, Xiaocan Jia, Zhe Li, Feng Xue, Xiaojuan Lian and Yanxia Wang
Vaccines 2025, 13(9), 972; https://doi.org/10.3390/vaccines13090972 - 13 Sep 2025
Viewed by 3081
Abstract
Background: The persistence of non-neonatal tetanus (non-NT) highlights the necessity of adult booster vaccines and post-traumatic prophylaxis. This Phase I/III clinical trial aimed to evaluate the safety and immunogenicity of a new adsorbed tetanus vaccine. Methods: A randomized, double-blind, positive-controlled clinical [...] Read more.
Background: The persistence of non-neonatal tetanus (non-NT) highlights the necessity of adult booster vaccines and post-traumatic prophylaxis. This Phase I/III clinical trial aimed to evaluate the safety and immunogenicity of a new adsorbed tetanus vaccine. Methods: A randomized, double-blind, positive-controlled clinical trial was conducted in Henan Province, China. A total of 1258 healthy participants aged 18–44 years (60 in Phase I and 1198 in Phase III) were enrolled, with no history of tetanus infection, or tetanus toxoid-containing vaccines (TTCVs) vaccination within the past 10 years. The participants were randomly assigned at a 1:1 ratio to receive a single dose of either the investigational vaccine or the licensed control vaccine. The Phase III clinical trial was initiated subsequent to the 7-day safety observation period following vaccination in the Phase I trial. The objective of the Phase III clinical trial was to assess the non-inferiority of the seroconversion rate of tetanus antibodies at 30 days post-vaccination with the investigational vaccine compared to the control vaccine. Serum samples were collected prior to and at 30 days post-vaccination. Adverse events were monitored for 30 days, with serious adverse events (SAEs) followed up for 6 months post-vaccination. Results: The investigational group achieved a seroconversion rate of 99.48%, which was non-inferior to that of the control group (99.66%), with a negligible rate difference of −0.17% (95% confidence interval [CI]: −1.20%, 0.78%). The investigational group exhibited a significantly higher geometric mean concentration (GMC) of antibodies (4.721 IU/mL vs. 3.627 IU/mL, p < 0.0001). Among the susceptible participants, the seroconversion rates were 99.78% in the investigational group and 99.79% in the control group, respectively, with a non-inferior rate difference of −0.01% (95%CI: −1.06%, 0.97%). Furthermore, the investigational group showed a low incidence of adverse reactions (ARs) within 30 days post-vaccination (12.26%), which was comparable to that of the control group (13.65%). All the reported ARs were mild or moderate, and no SAEs were associated with the vaccination. Conclusions: The new adsorbed tetanus vaccine demonstrated favorable safety and comparable immunogenicity to the marketed control vaccine, with a significantly higher antibody GMC, supporting its clinical application in tetanus prevention. Full article
(This article belongs to the Special Issue Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety)
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23 pages, 4707 KB  
Article
Transcriptomic Analysis of Immune Tolerance Induction in NOD Mice Following Oral Vaccination with GAD65-Lactococcus lactis
by Mengxin Xie, Chunli Ma, Xinyi Wang, Tengjiao Li, Shihan Zhang, Jiandong Shi, Jing Sun and Yunzhang Hu
Vaccines 2025, 13(9), 927; https://doi.org/10.3390/vaccines13090927 - 30 Aug 2025
Cited by 1 | Viewed by 2075
Abstract
Background: Type 1 diabetes (T1D) is an autoimmune disorder characterized by destruction of insulin-producing β-cells. While conventional insulin therapy manages hyperglycemia, it fails to halt autoimmunity. Oral immunotherapy targeting autoantigens like GAD65 offers potential for antigen-specific tolerance; however, its efficacy is limited by [...] Read more.
Background: Type 1 diabetes (T1D) is an autoimmune disorder characterized by destruction of insulin-producing β-cells. While conventional insulin therapy manages hyperglycemia, it fails to halt autoimmunity. Oral immunotherapy targeting autoantigens like GAD65 offers potential for antigen-specific tolerance; however, its efficacy is limited by gastrointestinal degradation and poor mucosal uptake. Lactococcus lactis (L. lactis), a food-grade delivery vector, enables sustained antigen release and intestinal tract immune modulation, yet the differential transcriptomic mechanisms underlying mucosal versus systemic immune responses remain uncharacterized. Methods: Non-obese diabetic (NOD) mice were randomized into control and GAD65 groups, receiving oral PBS or the GAD65 recombinant L. lactis vaccine, respectively. Fasting blood glucose was monitored weekly. GAD65-specific IgA and IgG, along with immune tolerance-related factors, were quantified using ELISA. Lymphocyte subsets were analyzed by flow cytometry, alongside RNA sequencing and transcriptional profiling. Results: The study demonstrated that the orally administered GAD65-L. lactis vaccine could significantly induce GAD65-specific IgA antibody and TGF-β cytokine and alleviate hyperglycemia and diabetes symptoms in NOD mice. Our study facilitated the induction of GAD65-specific regulatory T cells within both intestinal lamina propria lymphocytes (LPLs) and splenic lymphocytes. Notably, antigen-specific tolerance was mainly observed in intestinal LPLs. Crucially, the immune responses elicited by the vaccine demonstrated significant disparities between intestinal LPLs and splenic lymphocytes, with intestinal LPLs exhibiting unique local immune tolerance transcriptomic profiles. Conclusions: Our findings have enhanced the comprehension of the mechanisms by which oral vaccines influence the interplay between mucosal and systemic immune responses, thereby establishing a foundational framework for the design of oral vaccines. This understanding is instrumental in advancing antigen-specific immune tolerance strategies for autoimmune diseases such as Type 1 Diabetes (T1D). Full article
(This article belongs to the Special Issue Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety)
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17 pages, 3359 KB  
Article
Development and Biological Properties of a New Live Attenuated Mumps Vaccine Strain
by Xue Song, Xiumei Ren, Yang Song, Shengbao Yang, Kailang Lu, Yan Zhang and Jiankai Liu
Vaccines 2025, 13(8), 879; https://doi.org/10.3390/vaccines13080879 - 20 Aug 2025
Viewed by 1650
Abstract
Background/Objectives: This study aimed to develop a new attenuated live mumps vaccine strain and determine its biological properties and effectiveness. Methods: Plaque purification and amplification were performed in chicken embryo cells. Candidate live attenuated mumps MuV-365 strain sequencing was performed. After [...] Read more.
Background/Objectives: This study aimed to develop a new attenuated live mumps vaccine strain and determine its biological properties and effectiveness. Methods: Plaque purification and amplification were performed in chicken embryo cells. Candidate live attenuated mumps MuV-365 strain sequencing was performed. After evaluating the potential neurotoxicity of the MuV-365 mumps strain, a preclinical safety evaluation of measles–mumps–rubella (MMR) live attenuated vaccine containing the MuV-365 strain was performed to support the registration and application of the MMR vaccine. Finally, mumps neutralization antibody titers and the concentration of anti-serum mumps-specific IgG were determined to evaluate the immunogenicity and efficacy of the MuV-365 strain and MMR vaccine in mice and rhesus monkeys. Results: The plaque of the PL-KUM main seed virus was screened, and strains whose sequences were highly homologous to RIT4385 (JL-5 derived) were selected to amplify. The candidate live attenuated mumps MuV-365 strain was then developed. Safety evaluation results indicated that the MuV-365 strain had no potential neurotoxicity, and the MMR vaccine containing the MuV-365 strain also showed no significant safety hazard. The immunogenicity of MuV-365 strain in BALB/c mice was not inferior to S79 and PL-KUM. After two doses of the MuV-365 strain, the concentration of anti-serum mumps-specific IgG of the MuV-365 strain was significantly higher than that of the S79 strain (p < 0.01). In rhesus monkeys, the MMR vaccine had good immunogenicity against measles and rubella after one dose, while immunogenicity against mumps improved after two doses. Conclusions: The developed MuV-365 strain was genetically stable, with adequate safety and immunogenicity. Full article
(This article belongs to the Special Issue Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety)
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Review

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47 pages, 3011 KB  
Review
Current Status and Challenges of Vaccine Development for Seasonal Human Coronaviruses
by Bin Zhang, Yaoming Liu, Tao Chen, Jintao Lai, Sen Liu, Xiaoqing Liu, Yiqiang Zhu, Haiyue Rao, Haojie Peng and Xiancai Ma
Vaccines 2025, 13(11), 1168; https://doi.org/10.3390/vaccines13111168 - 16 Nov 2025
Cited by 1 | Viewed by 3336
Abstract
Seasonal human coronaviruses (HCoVs), including HCoV-229E, HCoV-NL63, HCoV-OC43, and HCoV-HKU1, circulate globally in an epidemic pattern and account for a substantial proportion of common cold cases, particularly in infants, the elderly, and immunocompromised individuals. Although clinical manifestations are typically mild, these HCoVs exhibit [...] Read more.
Seasonal human coronaviruses (HCoVs), including HCoV-229E, HCoV-NL63, HCoV-OC43, and HCoV-HKU1, circulate globally in an epidemic pattern and account for a substantial proportion of common cold cases, particularly in infants, the elderly, and immunocompromised individuals. Although clinical manifestations are typically mild, these HCoVs exhibit ongoing antigenic drift and have demonstrated the potential to cause severe diseases in certain populations, underscoring the importance of developing targeted and broad-spectrum vaccines. This review systematically examines the pathogenesis, epidemiology, genomic architecture, and major antigenic determinants of seasonal HCoVs, highlighting key differences in receptor usage and the roles of structural proteins in modulating viral tropism and host immunity. We summarize recent advances across various vaccine platforms, including inactivated, DNA, mRNA, subunit, viral-vectored, and virus-like particle (VLP) approaches, in the development of seasonal HCoV vaccines. We specifically summarize preclinical and clinical findings demonstrating variable cross-reactivity between SARS-CoV-2 and seasonal HCoV vaccines. Evidence indicates that cross-reactive humoral and cellular immune responses following SARS-CoV-2 infection or vaccination predominantly target conserved epitopes of structural proteins, supporting strategies that incorporate conserved regions to achieve broad-spectrum protection. Finally, we discuss current challenges in pathogenesis research and vaccine development for seasonal HCoVs. We propose future directions for the development of innovative pan-coronavirus vaccines that integrate both humoral and cellular antigens, aiming to protect vulnerable populations and mitigate future zoonotic spillover threats. Full article
(This article belongs to the Special Issue Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety)
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28 pages, 569 KB  
Review
What Stage Are We at in the Development of Vaccines Against Tick-Borne Diseases?
by Weronika Stachera, Magdalena Szuba, Arya Taesung Kim, Subin Yu, Jaeuk Choi, Deborah Nzekea, Yen Ching Wu, Adrianna Brzozowska, Marcin Sota, Marianna Misiak and Monika Dybicz
Vaccines 2025, 13(9), 990; https://doi.org/10.3390/vaccines13090990 - 22 Sep 2025
Cited by 3 | Viewed by 3574
Abstract
The increasing prevalence of Lyme disease, tick-borne encephalitis (TBE), and other tick-borne infections such as Babesia, Ehrlichia, Rickettsia, and Anaplasma is a growing public health concern. Existing tick bite prevention strategies are insufficient; therefore, vaccines represent a promising preventive measure. [...] Read more.
The increasing prevalence of Lyme disease, tick-borne encephalitis (TBE), and other tick-borne infections such as Babesia, Ehrlichia, Rickettsia, and Anaplasma is a growing public health concern. Existing tick bite prevention strategies are insufficient; therefore, vaccines represent a promising preventive measure. At the moment, only a vaccine for tick-borne encephalitis is available on the market. A vaccine for Lyme disease, however, is at an advanced stage of clinical trials. In this article, we focus on describing the progress in the invention of vaccines for tick-borne diseases. This article analyzes their development and effectiveness. Full article
(This article belongs to the Special Issue Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety)
21 pages, 640 KB  
Review
Advances in Contraceptive Vaccine Development: A Comprehensive Review
by Wen Gao, Xiaoting Shen, Peipei Li, Chanchan Xiao and Yongxia Wang
Vaccines 2025, 13(7), 692; https://doi.org/10.3390/vaccines13070692 - 26 Jun 2025
Cited by 2 | Viewed by 4637
Abstract
The issues of uncontrolled global population growth and unintended pregnancies are severe, and the existing contraceptive methods have numerous limitations, making the development of novel contraceptive technologies urgent. Contraceptive vaccines offer a promising alternative to traditional contraception methods. This article reviews the three [...] Read more.
The issues of uncontrolled global population growth and unintended pregnancies are severe, and the existing contraceptive methods have numerous limitations, making the development of novel contraceptive technologies urgent. Contraceptive vaccines offer a promising alternative to traditional contraception methods. This article reviews the three developmental stages of contraceptive vaccines, including early exploration, technical bottlenecks, and innovative development directions in the new era. This article also summarizes the targets of immunocontraception, covering the current research status of contraceptive vaccines targeting sperm production, sperm antigens, oocyte zona pellucida, and gamete outcomes. Furthermore, this article explores the advantages of contraceptive vaccines in terms of efficiency, non-invasiveness, reversibility, and the promotion of gender equality. Challenges associated with clinical translation and real-world implementation are also critically analyzed. Full article
(This article belongs to the Special Issue Advancements in Vaccine Research: Epidemiology, Immunogenicity, Effectiveness and Safety)
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