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Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination...
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Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans

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

Deadline for manuscript submissions: 31 July 2025 | Viewed by 7402

Special Issue Editor

Dr. Kay Choong See

E-Mail Website
Guest Editor
Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, Singapore 119228, Singapore
Interests: respiratory infection; intensive care medicine; public health
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

I am pleased to invite you to contribute to an upcoming Special Issue, titled "Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans". Vaccination remains a cornerstone in preventing infectious diseases and is a key contributor to global health. In this context, advancing clinical strategies is crucial for enhancing the overall impact of vaccination programs.

The scientific foundation of this Special Issue lies in addressing current challenges and exploring innovative approaches to optimize vaccination outcomes. Embracing a broad scope, we welcome contributions involving, but not limited to, the following:

  1. Participants of all ages.
  2. Special populations as those with comorbid conditions and immunocompromised patients.
  3. The use of any human vaccine platform.
  4. Diverse research designs, including randomized trials, nonrandomized trials, quality improvement studies, case–control studies, systematic reviews, and narrative reviews.
  5. Clinical vaccine research and utilization under controlled or real-world settings.

I look forward to receiving your valuable contributions.

Dr. Kay Choong See
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 100 words) can be sent to the Editorial Office for announcement on this website.

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

  • adenovirus vaccines
  • immunologic adjuvants
  • adult
  • communicable diseases
  • geriatrics
  • immunocompromised Host
  • mRNA vaccines
  • pediatrics
  • public health
  • attenuated vaccines
  • inactivated vaccines

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (6 papers)

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Research

16 pages, 3254 KiB  
Article
Low Antibody-Dependent Enhancement of Viral Entry Activity Supports the Safety of Inactivated SARS-CoV-2 Vaccines
by Xiaofang Peng, Yuru Han, Song Xue, Yunjiao Zhou, Weiyu Jiang, Anqi Xia, Wei Wu, Yidan Gao, Fan Wu and Qiao Wang
Vaccines 2025, 13(4), 425; https://doi.org/10.3390/vaccines13040425 - 18 Apr 2025
Viewed by 401
Abstract
Background/Objectives: The antibody-dependent enhancement (ADE) of viral entry has been documented for SARS-CoV-2 infection both in vitro and in vivo. However, the potential for the SARS-CoV-2 vaccination to elicit similar ADE effects remains unclear. Methods: In this study, we assessed the in vitro [...] Read more.
Background/Objectives: The antibody-dependent enhancement (ADE) of viral entry has been documented for SARS-CoV-2 infection both in vitro and in vivo. However, the potential for the SARS-CoV-2 vaccination to elicit similar ADE effects remains unclear. Methods: In this study, we assessed the in vitro ADE potential of monoclonal antibodies (mAbs) derived from individuals vaccinated with the inactivated SARS-CoV-2 vaccine and compared them to those from one convalescent donor. Results: Our analysis revealed no significant difference in binding affinity or neutralizing capacity between the vaccinated and convalescent mAbs. However, the inactivated SARS-CoV-2 vaccination induced fewer ADE-inducing mAbs, particularly those targeting the Class III epitope on the receptor-binding domain (RBD) compared to those from the convalescent individual. Moreover, no significant in vitro ADE was detected in either vaccinated or convalescent sera, indicating low levels of ADE-inducing antibodies in the sera. Conclusions: An inactivated SARS-CoV-2 vaccination induces fewer ADE-inducing antibodies compared to natural infection, further emphasizing the safety of inactivated SARS-CoV-2 vaccines. Full article
(This article belongs to the Special Issue Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans)
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18 pages, 1035 KiB  
Article
Adverse Events Following Haemophilus influenzae Type b (Hib) Monovalent Vaccines in Zhejiang Province, China, from 2017 to 2023
by Xuejiao Pan, Yaping Chen, Hui Liang, Linzhi Shen and Xiaohua Qi
Vaccines 2025, 13(4), 349; https://doi.org/10.3390/vaccines13040349 - 25 Mar 2025
Viewed by 464
Abstract
Background: The Haemophilus influenzae type b (Hib) vaccination has well-established safety and efficacy in preventing Hib and reducing related morbidity and mortality worldwide. China has a high disease burden of Hib yet a low coverage rate of Hib vaccines and remains the only [...] Read more.
Background: The Haemophilus influenzae type b (Hib) vaccination has well-established safety and efficacy in preventing Hib and reducing related morbidity and mortality worldwide. China has a high disease burden of Hib yet a low coverage rate of Hib vaccines and remains the only WHO member country not including the Hib vaccine in its National Immunization Program (NIP), partly due to insufficient surveillance data on its safety. This study analyzed all adverse events following immunization (AEFIs) after Hib monovalent vaccination in Zhejiang Province from 2017 to 2023 to provide evidence for formulating relevant immunization strategies. Methods: Hib vaccine-related AEFIs in Zhejiang Province from 1 January 2017, to 31 December 2023, were collected through the Chinese National AEFI Information System (CNAEFIS) for a descriptive epidemiological analysis. Results: From 2017 to 2023, a total of 1740 Hib vaccine-related AEFIs were reported (incidence rate: 63.01/100,000 doses) (95%CI: 60.12/100,000 doses–66.04/100,000 doses), including 1577 common adverse reactions (57.10/100,000 doses) (95%CI: 54.35/100,000 doses–59.99/100,000 doses), 139 rare adverse reactions (5.03/100,000 doses) (95%CI: 4.26/100,000 doses–5.94/100,000 doses), and 24 coincidental events (0.87/100,000 doses) (95%CI: 0.58/100,000 doses–1.29/100,000 doses). Most of the AEFIs were common adverse reactions that manifested mainly as fever, injection site redness and swelling, and crying. AEFIs were more likely to occur in male participants under the age of one, in summer and autumn, and during the booster immunity stage. The top three regions with the highest reported incidence rates of AEFIs were Jiaxing City (86.61/100,000 doses) (95%CI: 74.44/100,000 doses–100.77/100,000 doses), Hangzhou City (81.29/100,000 doses) (95%CI: 72.56/100,000 doses–91.07/100,000 doses), and Taizhou City (66.62/100,000 doses) (95%CI: 58.24/100,000 doses–76.21/100,000 doses). Conclusions: Our findings provide preliminary evidence of the safety profile of the Hib vaccine at a provincial level, which adds further support for its broader implementation in other provinces. Future multi-center studies are needed to construct a comprehensive vaccine evaluation framework and make multi-criteria decisions on the feasibility of incorporating the Hib vaccine into China’s NIP. Full article
(This article belongs to the Special Issue Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans)
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14 pages, 1298 KiB  
Article
Impact of DTaP-IPV and DTaP Vaccination Among Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients: A Prospective Observational Study
by Taiichiro Kobayashi, Sho Fujiwara, Ayako Ide, Takashi Toya, Naoki Shingai, Hiroaki Shimizu, Yuho Najima, Takeshi Kobayashi, Noriko Doki and Aoi Jo
Vaccines 2025, 13(3), 275; https://doi.org/10.3390/vaccines13030275 - 5 Mar 2025
Viewed by 1329
Abstract
Background/Objectives: Hematopoietic stem cell transplantation (HSCT) can potentially cure hematological malignancies; however, post-transplant patients have a high risk of infection owing to their immunocompromised status. Vaccination against pathogens, such as diphtheria, tetanus, pertussis, and polio, is essential post-transplantation, but neither the long-term [...] Read more.
Background/Objectives: Hematopoietic stem cell transplantation (HSCT) can potentially cure hematological malignancies; however, post-transplant patients have a high risk of infection owing to their immunocompromised status. Vaccination against pathogens, such as diphtheria, tetanus, pertussis, and polio, is essential post-transplantation, but neither the long-term efficacy of vaccines nor the optimal vaccination schedule has been fully established. Methods: In this prospective observational study, we assessed the short- and long-term immunogenicity of three doses of the diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccines or DTaP vaccines in 29 adult allogeneic HSCT (allo-HSCT) recipients, with antibody levels measured at baseline, 1–3 months post-vaccination, and 1-year after vaccine completion. Results: At baseline, a substantial proportion of patients lacked protective antibody levels for the targeted pathogens. However, within 1–3 months post-vaccination, seropositivity rates significantly increased, reaching 78–100% for diphtheria, tetanus, pertussis, and poliovirus. Despite this, antibody levels significantly declined 1-year post-vaccination, especially for pertussis, with only 58–65% of patients maintaining protective levels. In contrast, 85–96% of patients retained protective levels for diphtheria, tetanus, and poliovirus, although antibody values also decreased. Compared to human leukocyte antigen (HLA)-mismatched cases, HLA-matched cases showed significantly higher antibody levels for diphtheria, pertussis, and poliovirus types 1 and 3. Conclusions: This study demonstrates the short-term effectiveness of DTaP-IPV and DTaP vaccines in adult allo-HSCT patients but emphasizes the challenge of maintaining long-term immunity. Given the difficulties in sustaining long-term vaccine efficacy in allo-HSCT recipients, particularly in HLA-mismatched cases, re-evaluating the current vaccination schedule may be necessary to maintain protection. Full article
(This article belongs to the Special Issue Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans)
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13 pages, 392 KiB  
Article
Surveillance of Adverse Events Following Varicella Vaccine Immunization in Zhejiang Province, China, from 2020 to 2022
by Hui Liang, Xiaohua Qi, Yaping Chen and Xuejiao Pan
Vaccines 2025, 13(1), 57; https://doi.org/10.3390/vaccines13010057 - 10 Jan 2025
Cited by 3 | Viewed by 924
Abstract
Background: China has a high incidence rate of varicella yet a low coverage rate of the varicella vaccine (VarV), with safety concerns being a leading cause of the lack of vaccination willingness. This study aimed to describe VarV-related adverse events following immunization [...] Read more.
Background: China has a high incidence rate of varicella yet a low coverage rate of the varicella vaccine (VarV), with safety concerns being a leading cause of the lack of vaccination willingness. This study aimed to describe VarV-related adverse events following immunization (AEFIs) and analyze their characteristics in Zhejiang, China, 2020–2022. Methods: VarV-related AEFIs in Zhejiang Province from 1 January 2020 to 31 December 2022 were collected through the Chinese National AEFI Information System (CNAEFIS) for a descriptive epidemiological analysis. Results: From 2020 to 2022, a total of 1477 VarV-related AEFI cases were reported (incidence rate: 34.79/100,000). The three most frequently reported clinical symptoms of common adverse reactions were fever, redness, and induration at the vaccination site. The distribution of VarV-related AEFIs varied significantly by age, dose, severity, and season. VarV-related AEFIs were more likely to be non-severe adverse events that occurred in the summer and winter seasons following the first dose of vaccine and among those under 3 years old. The top three regions with the highest incidence rates were Lishui City (59.53/100,000), Quzhou City (41.05/100,000), and Jinhua City (40.43/100,000). Most of the cases achieved full recovery without treatment (96.21%), and the rest were successfully treated without any sequelae. Conclusions: VarV demonstrates a safe profile in Zhejiang Province. Most VarV-related AEFIs are common reactions without requiring treatment, and the rates of rare and severe AEFIs remain low. Consistent monitoring, investigation, and diagnosis are needed to guide future VarV research and vaccination strategy adjustment. Our findings call for more policy changes, such as integrating VarV into China’s National Immunization Program and conducting more trials to evaluate the safety and effectiveness of VarV. Full article
(This article belongs to the Special Issue Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans)
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16 pages, 2710 KiB  
Article
Evaluation of Safety, Immunogenicity and Cross-Reactive Immunity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, in Older Adults
by Bart Jacobs, Isabel Leroux-Roels, Jacques Bruhwyler, Nicola Groth, Gwenn Waerlop, Yorick Janssens, Jessika Tourneur, Fien De Boever, Azhar Alhatemi, Philippe Moris, Alexandre Le Vert, Geert Leroux-Roels and Florence Nicolas
Vaccines 2024, 12(12), 1391; https://doi.org/10.3390/vaccines12121391 - 11 Dec 2024
Viewed by 1403
Abstract
Background/Objectives: In a Phase 2a, double-blind, placebo-controlled study including healthy participants aged 18–55 years, OVX836, a nucleoprotein (NP)-based candidate vaccine, previously showed a good safety profile, a robust immune response (both humoral and cellular) and a preliminary signal of protection (VE = 84%) [...] Read more.
Background/Objectives: In a Phase 2a, double-blind, placebo-controlled study including healthy participants aged 18–55 years, OVX836, a nucleoprotein (NP)-based candidate vaccine, previously showed a good safety profile, a robust immune response (both humoral and cellular) and a preliminary signal of protection (VE = 84%) against PCR-confirmed symptomatic influenza after a single intramuscular dose of 180 µg, 300 µg or 480 µg. Methods: Using the same methodology, we confirmed the good safety and strong immunogenicity of OVX836 at the same doses in older adults (≥65 years), a key target population for influenza vaccination. Results: Significant humoral (anti-NP IgG) and cellular (interferon gamma (IFNγ) spot-forming cells per million peripheral blood mononuclear cells and specific CD4+ IFNγ+ T-cells) immune responses were observed at the three dose levels, without clear dose–response relationship. T-cell responses were shown to be highly cross-reactive against various influenza A strains, both seasonal and highly pathogenic avian strains. We also evaluated the effect of sex (stronger immune response in females) and age (stronger immune response in young adults) on the immune response to OVX836 after adjustment based on the pre-vaccination immune status. Conclusions: The results obtained with OVX836 lay the groundwork for a future placebo-controlled, field proof of concept efficacy Phase 2b trial. Full article
(This article belongs to the Special Issue Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans)
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15 pages, 4038 KiB  
Article
Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial
by Julie A. Ake, Kristopher Paolino, Jack N. Hutter, Susan Biggs Cicatelli, Leigh Anne Eller, Michael A. Eller, Margaret C. Costanzo, Dominic Paquin-Proulx, Merlin L. Robb, Chi L. Tran, Lalaine Anova, Linda L. Jagodzinski, Lucy A. Ward, Nicole Kilgore, Janice Rusnak, Callie Bounds, Christopher S. Badorrek, Jay W. Hooper, Steven A. Kwilas, Ine Ilsbroux, Dickson Nkafu Anumendem, Auguste Gaddah, Georgi Shukarev, Viki Bockstal, Kerstin Luhn, Macaya Douoguih and Cynthia Robinsonadd Show full author list remove Hide full author list
Vaccines 2024, 12(5), 497; https://doi.org/10.3390/vaccines12050497 - 4 May 2024
Cited by 2 | Viewed by 2141
Abstract
The safety and immunogenicity of the two-dose Ebola vaccine regimen MVA-BN-Filo, Ad26.ZEBOV, 14 days apart, was evaluated in people without HIV (PWOH) and living with HIV (PLWH). In this observer-blind, placebo-controlled, phase 2 trial, healthy adults were randomized (4:1) to receive MVA-BN-Filo (dose [...] Read more.
The safety and immunogenicity of the two-dose Ebola vaccine regimen MVA-BN-Filo, Ad26.ZEBOV, 14 days apart, was evaluated in people without HIV (PWOH) and living with HIV (PLWH). In this observer-blind, placebo-controlled, phase 2 trial, healthy adults were randomized (4:1) to receive MVA-BN-Filo (dose 1) and Ad26.ZEBOV (dose 2), or two doses of saline/placebo, administered intramuscularly 14 days apart. The primary endpoints were safety (adverse events (AEs)) and immunogenicity (Ebola virus (EBOV) glycoprotein-specific binding antibody responses). Among 75 participants (n = 50 PWOH; n = 25 PLWH), 37% were female, the mean age was 44 years, and 56% were Black/African American. AEs were generally mild/moderate, with no vaccine-related serious AEs. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody responder rates were 100% among PWOH and 95% among PLWH; geometric mean antibody concentrations were 6286 EU/mL (n = 36) and 2005 EU/mL (n = 19), respectively. A total of 45 neutralizing and other functional antibody responses were frequently observed. Ebola-specific CD4+ and CD8+ T-cell responses were polyfunctional and durable to at least 12 months post-dose 2. The regimen was well tolerated and generated robust, durable immune responses in PWOH and PLWH. Findings support continued evaluation of accelerated vaccine schedules for rapid deployment in populations at immediate risk. Trial registration: NCT02598388 (submitted 14 November 2015). Full article
(This article belongs to the Special Issue Clinical Strategies to Improve Efficacy, Effectiveness, and Safety of Vaccination in Humans)
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