Vaccines

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Open AccessArticle

Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

by Yoshikazu Nakayama and Atsushi Aruga

Vaccines 2015, 3(1), 186-202; https://doi.org/10.3390/vaccines3010186 - 18 Mar 2015

Cited by 17 | Viewed by 10574

Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are [...] Read more.

Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. Full article

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Open AccessReview

Emerging Influenza Strains in the Last Two Decades: A Threat of a New Pandemic?

by Claudia Trombetta, Simona Piccirella, Daniele Perini, Otfried Kistner and Emanuele Montomoli

Vaccines 2015, 3(1), 172-185; https://doi.org/10.3390/vaccines3010172 - 18 Mar 2015

Cited by 37 | Viewed by 8244

Abstract

In the last 20 years, novel non-seasonal influenza viruses have emerged, most of which have originated from birds. Despite their apparent inability to cause pandemics, with the exception of H1N1 swine influenza virus, these viruses still constitute a constant threat to public health. [...] Read more.

In the last 20 years, novel non-seasonal influenza viruses have emerged, most of which have originated from birds. Despite their apparent inability to cause pandemics, with the exception of H1N1 swine influenza virus, these viruses still constitute a constant threat to public health. While general concern has decreased after the peak of the H5N1 virus, in recent years several novel reassorted influenza viruses (e.g., H7N9, H9N2, H10N8) have jumped the host-species barrier and are under surveillance by the scientific community and public health systems. It is still unclear whether these viruses can actually cause pandemics or just isolated episodes. The purpose of this review is to provide an overview of old and novel potential pandemic strains of recent decades. Full article

(This article belongs to the Special Issue Influenza Vaccines)

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Open AccessReview

Choice and Design of Adjuvants for Parenteral and Mucosal Vaccines

by Huub F. J. Savelkoul, Valerie A. Ferro, Marius M. Strioga and Virgil E. J. C. Schijns

Vaccines 2015, 3(1), 148-171; https://doi.org/10.3390/vaccines3010148 - 5 Mar 2015

Cited by 65 | Viewed by 10717

Abstract

The existence of pathogens that escape recognition by specific vaccines, the need to improve existing vaccines and the increased availability of therapeutic (non-infectious disease) vaccines necessitate the rational development of novel vaccine concepts based on the induction of protective cell-mediated immune responses. For [...] Read more.

The existence of pathogens that escape recognition by specific vaccines, the need to improve existing vaccines and the increased availability of therapeutic (non-infectious disease) vaccines necessitate the rational development of novel vaccine concepts based on the induction of protective cell-mediated immune responses. For naive T-cell activation, several signals resulting from innate and adaptive interactions need to be integrated, and adjuvants may interfere with some or all of these signals. Adjuvants, for example, are used to promote the immunogenicity of antigens in vaccines, by inducing a pro-inflammatory environment that enables the recruitment and promotion of the infiltration of phagocytic cells, particularly antigen-presenting cells (APC), to the injection site. Adjuvants can enhance antigen presentation, induce cytokine expression, activate APC and modulate more downstream adaptive immune reactions (vaccine delivery systems, facilitating immune Signal 1). In addition, adjuvants can act as immunopotentiators (facilitating Signals 2 and 3) exhibiting immune stimulatory effects during antigen presentation by inducing the expression of co-stimulatory molecules on APC. Together, these signals determine the strength of activation of specific T-cells, thereby also influencing the quality of the downstream T helper cytokine profiles and the differentiation of antigen-specific T helper populations (Signal 3). New adjuvants should also target specific (innate) immune cells in order to facilitate proper activation of downstream adaptive immune responses and homing (Signal 4). It is desirable that these adjuvants should be able to exert such responses in the context of mucosal administered vaccines. This review focuses on the understanding of the potential working mechanisms of the most well-known classes of adjuvants to be used effectively in vaccines. Full article

(This article belongs to the Special Issue Vaccine Adjuvants)

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Open AccessArticle

Beliefs and Opinions of Health Care Workers and Students Regarding Influenza and Influenza Vaccination in Tuscany, Central Italy

by Guglielmo Bonaccorsi, Francesca Santomauro, Barbara Rita Porchia, Giuditta Niccolai, Elettra Pellegrino, Paolo Bonanni and Chiara Lorini

Vaccines 2015, 3(1), 137-147; https://doi.org/10.3390/vaccines3010137 - 26 Feb 2015

Cited by 36 | Viewed by 7358

Abstract

Immunization of health care workers (HCWs) against influenza has been associated with improvements in patient safety. The aim of this study is to assess the beliefs, attitudes, and knowledge of HCWs and health profession students regarding influenza. An anonymous questionnaire was distributed to [...] Read more.

Immunization of health care workers (HCWs) against influenza has been associated with improvements in patient safety. The aim of this study is to assess the beliefs, attitudes, and knowledge of HCWs and health profession students regarding influenza. An anonymous questionnaire was distributed to HCWs in three local Florentine healthcare units, at Careggi University Teaching Hospital, and to students in health profession degree programs. A total of 2576 questionnaires were fully completed. A total of 12.3% of subjects responded that they were “always vaccinated” in all three of the seasonal vaccination campaigns studied (2007–2008 to 2009–2010), 13.1% had been vaccinated once or twice, and 74.6% had not received vaccinations. Although the enrolled subjects tended to respond that they were “never vaccinated,” they considered influenza to be a serious illness and believed that the influenza vaccine is effective. The subjects who refused vaccination more frequently believed that the vaccine could cause influenza and that it could have serious side effects. More than 60% of the “always vaccinated” group completely agreed that HCWs should be vaccinated. Self-protection and protecting family members or other people close to the respondent from being infected and representing potential sources of influenza infection can be considered motivating factors for vaccination. The results highlight the importance of improving vaccination rates among all HCWs through multi-component interventions. Knowledge of influenza should be reinforced. Full article

(This article belongs to the Special Issue Influenza Vaccines)

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Open AccessReview

M2e-Based Universal Influenza A Vaccines

by Lei Deng, Ki Joon Cho, Walter Fiers and Xavier Saelens

Vaccines 2015, 3(1), 105-136; https://doi.org/10.3390/vaccines3010105 - 13 Feb 2015

Cited by 147 | Viewed by 18405

Abstract

The successful isolation of a human influenza virus in 1933 was soon followed by the first attempts to develop an influenza vaccine. Nowadays, vaccination is still the most effective method to prevent human influenza disease. However, licensed influenza vaccines offer protection against antigenically [...] Read more.

The successful isolation of a human influenza virus in 1933 was soon followed by the first attempts to develop an influenza vaccine. Nowadays, vaccination is still the most effective method to prevent human influenza disease. However, licensed influenza vaccines offer protection against antigenically matching viruses, and the composition of these vaccines needs to be updated nearly every year. Vaccines that target conserved epitopes of influenza viruses would in principle not require such updating and would probably have a considerable positive impact on global human health in case of a pandemic outbreak. The extracellular domain of Matrix 2 (M2e) protein is an evolutionarily conserved region in influenza A viruses and a promising epitope for designing a universal influenza vaccine. Here we review the seminal and recent studies that focused on M2e as a vaccine antigen. We address the mechanism of action and the clinical development of M2e-vaccines. Finally, we try to foresee how M2e-based vaccines could be implemented clinically in the future. Full article

(This article belongs to the Special Issue Influenza Vaccines)

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Open AccessReview

Assaying the Potency of Influenza Vaccines

by Philip D. Minor

Vaccines 2015, 3(1), 90-104; https://doi.org/10.3390/vaccines3010090 - 5 Feb 2015

Cited by 52 | Viewed by 8969

Abstract

The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficult but also confounds attempts to produce [...] Read more.

The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficult but also confounds attempts to produce a well-validated, consistent potency assay. Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine. It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought. Full article

(This article belongs to the Special Issue Influenza Vaccines)

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Open AccessArticle

EBV-Associated Cancer and Autoimmunity: Searching for Therapies

by Giovanni Capone, Candida Fasano, Guglielmo Lucchese, Michele Calabrò and Darja Kanduc

Vaccines 2015, 3(1), 74-89; https://doi.org/10.3390/vaccines3010074 - 5 Feb 2015

Cited by 16 | Viewed by 6878

Abstract

Epstein-Barr virus (EBV) infects B-, T-, and NK cells and has been associated not only with a wide range of lymphoid malignancies but also with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis and, in particular, multiple sclerosis. Hence, effective immunotherapeutic approaches to [...] Read more.

Epstein-Barr virus (EBV) infects B-, T-, and NK cells and has been associated not only with a wide range of lymphoid malignancies but also with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis and, in particular, multiple sclerosis. Hence, effective immunotherapeutic approaches to eradicate EBV infection might overthrow cancer and autoimmunity incidence. However, currently no effective anti-EBV immunotherapy is available. Here we use the concept that protein immunogenicity is allocated in rare peptide sequences and search the Epstein-Barr nuclear antigen 1 (EBNA1) sequence for peptides unique to the viral protein and absent in the human host. We report on a set of unique EBV EBNA1 peptides that might be used in designing peptide-based therapies able to specifically hitting the virus or neutralizing pathogenic autoantibodies. Full article

(This article belongs to the Special Issue Cancer Vaccines)

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Open AccessReview

Optimal Use of Vaccines for Control of Influenza A Virus in Swine

by Matthew R. Sandbulte, Anna R. Spickler, Pamela K. Zaabel and James A. Roth

Vaccines 2015, 3(1), 22-73; https://doi.org/10.3390/vaccines3010022 - 30 Jan 2015

Cited by 81 | Viewed by 15571

Abstract

Influenza A virus in swine (IAV-S) is one of the most important infectious disease agents of swine in North America. In addition to the economic burden of IAV-S to the swine industry, the zoonotic potential of IAV-S sometimes leads to serious public health [...] Read more.

Influenza A virus in swine (IAV-S) is one of the most important infectious disease agents of swine in North America. In addition to the economic burden of IAV-S to the swine industry, the zoonotic potential of IAV-S sometimes leads to serious public health concerns. Adjuvanted, inactivated vaccines have been licensed in the United States for over 20 years, and there is also widespread usage of autogenous/custom IAV-S vaccines. Vaccination induces neutralizing antibodies and protection against infection with very similar strains. However, IAV-S strains are so diverse and prone to mutation that these vaccines often have disappointing efficacy in the field. This scientific review was developed to help veterinarians and others to identify the best available IAV-S vaccine for a particular infected herd. We describe key principles of IAV-S structure and replication, protective immunity, currently available vaccines, and vaccine technologies that show promise for the future. We discuss strategies to optimize the use of available IAV-S vaccines, based on information gathered from modern diagnostics and surveillance programs. Improvements in IAV-S immunization strategies, in both the short term and long term, will benefit swine health and productivity and potentially reduce risks to public health. Full article

(This article belongs to the Special Issue Influenza Vaccines)

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Open AccessEditorial

Acknowledgement to Reviewers of Vaccines in 2014

by Vaccines Editorial Office

Vaccines 2015, 3(1), 20-21; https://doi.org/10.3390/vaccines3010020 - 8 Jan 2015

Viewed by 3869

Abstract

The editors of Vaccines would like to express their sincere gratitude to the following reviewers for assessing manuscripts in 2014:[...] Full article

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Open AccessArticle

The Potential Impact of Preventive HIV Vaccines in China: Results and Benefits of a Multi-Province Modeling Collaboration

by Thomas Harmon, Wei Guo, John Stover, Zunyou Wu, Joan Kaufman, Kammerle Schneider, Li Liu, Liao Feng and Bernard Schwartländer

Vaccines 2015, 3(1), 1-19; https://doi.org/10.3390/vaccines3010001 - 5 Jan 2015

Cited by 3 | Viewed by 8886

Abstract

China’s commitment to implementing established and emerging HIV/AIDS prevention and control strategies has led to substantial gains in terms of access to antiretroviral treatment and prevention services, but the evolving and multifaceted HIV/AIDS epidemic in China highlights the challenges of maintaining that response. [...] Read more.

China’s commitment to implementing established and emerging HIV/AIDS prevention and control strategies has led to substantial gains in terms of access to antiretroviral treatment and prevention services, but the evolving and multifaceted HIV/AIDS epidemic in China highlights the challenges of maintaining that response. This study presents modeling results exploring the potential impact of HIV vaccines in the Chinese context at varying efficacy and coverage rates, while further exploring the potential implications of vaccination programs aimed at reaching populations at highest risk of HIV infection. A preventive HIV vaccine would add a powerful tool to China’s response, even if not 100% efficacious or available to the full population. Full article

(This article belongs to the Special Issue Feature Papers)

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Vaccines, Volume 3, Issue 1 (March 2015) – 10 articles , Pages 1-202

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