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PubMed2026

Artificial intelligence for translational personalized neoantigen cancer vaccine development.

Personalized neoantigen cancer vaccine is a promising strategy for precision immunotherapy by targeting patient-specific and mutation-derived tumor antigens. Early clinical studies have demonstrated the feasibility, safety, and immunogenicity of these vaccines across multiple solid tumors, with encouraging outcomes particularly when combined with immune checkpoint blockade. However, broader clinical translation remains limited by sequential bottlenecks across the vaccine development pipeline, including false-positive neoantigen selection,  imperfect modeling of antigen processing and HLA presentation, limited prediction of T-cell receptor recognition, and challenges in formulation, delivery, and manufacturing. Artificial intelligence and advanced computational workflows are increasingly integrated into this pipeline to improve candidate prioritization and support more reproducible decision-making. In this review, we summarize clinical progress and key translational barriers in personalized neoantigen vaccination, and discuss how AI-enabled approaches may contribute across four major stages: multi-omics integration for neoantigen discovery, processing-aware HLA presentation prediction, structure-aware and TCR-informed immunogenicity modeling, and data-driven formulation optimization, particularly for lipid nanoparticle-based delivery systems. These approaches are able to help narrow biological and chemical search spaces, improve prioritization, and provide mechanistic insights into antigen presentation and immune recognition rather than replacing experimental validation. This articlefurther addresses future implementation challenges, including dataset diversity, model interpretability, prospective benchmarking, manufacturing traceability, and evolving regulatory frameworks for individualized mRNA cancer immunotherapies. Integrating computational innovation with rigorous immunological validation, scalable manufacturing, and regulatory oversight will be essential for advancing personalized neoantigen vaccines toward broader clinical implementation.

Cancer Vaccines↗
PubMed2002

Vaccine development against HIV-1: current perspectives and future directions.

The development of an efficacious vaccine against the human immunodeficiency virus (HIV) is of great urgency, because it is accepted that vaccination is the only means capable of controlling the AIDS pandemic. The foundation of HIV vaccine development is the analysis of immune responses during natural infection and the utilization of this knowledge for the development of protective immunization strategies. Initial vaccine development and experimentation are usually in animal models, including murine, feline, and nonhuman primates. Experimental vaccine candidates are closely studied for both efficacy and safety before proceeding to human clinical trials. There are a number of different therapeutic and prophylactic vaccine strategies currently being studied in human clinical trials. Vaccine strategies that are being tested, or have previously been tested, in humans include subunit, DNA plasmid, and viral vector, and combinations of these various strategies. Some of the results of these trials are promising, and additional research has focused on the development of appropriate chemical and genetic adjuvants as well as methods of vaccine delivery to improve the host immune response. This review summarizes the vaccine strategies that have been tested in both animal models and human clinical trials.

AIDS Vaccines↗
PubMed2005

Current progress in tuberculosis vaccine development.

The tuberculosis vaccine field has blossomed in the past 10 years, with over a hundred new candidates going through animal model testing, and several now entering or approaching clinical trial evaluation. In this brief review the current animal screening models are discussed, as are the various types of new vaccines that have been developed. New approaches, especially in the area of BCG boosting in various prime/boost protocols, are starting to show considerable promise. More sophisticated readouts, including imaging approaches such as magnetic resonance imaging, and better definition of the immunopathology of the lung disease process, should help accelerate vaccine development even further in the next decade.

Animals↗
PubMed2006

Vaccine development against malaria.

Malaria vaccine development aims to significantly reduce mortality and morbidity in the two high-risk groups: young children and pregnant women in sub-Saharan Africa. A pre-erythrocytic subunit vaccine, RTS,S, was recently evaluated in a first Phase IIb clinical trial in young children that live in a mesoendemic area of malaria transmission. The identification of a major parasite-encoded ligand that was found to be involved in pregnancy-associated malaria allows for the rational development of a tailor-made subunit vaccine for young women. The generation of transgenic yellow fever viruses and defined attenuated vaccine lines by reverse genetics are complementary approaches that might further boost the development of safe vaccines that elicit protective immune responses in this population.

Animals↗
PubMed2006

Viral vectors for malaria vaccine development.

A workshop on viral vectors for malaria vaccine development, organized by the PATH Malaria Vaccine Initiative, was held in Bethesda, MD on October 20, 2005. Recent advancements in viral-vectored malaria vaccine development and emerging vector technologies were presented and discussed. Classic viral vectors such as poxvirus, adenovirus and alphavirus vectors have been successfully used to deliver malaria antigens. Some of the vaccine candidates have demonstrated their potential in inducing malaria-specific immunity in animal models and human trials. In addition, emerging viral-vector technologies, such as measles virus (MV), vesicular stomatitis virus (VSV) and yellow fever (YF) virus, may also be useful for malaria vaccine development. Studies in animal models suggest that each viral vector is unique in its ability to induce humoral and/or cellular immune responses. Those studies have also revealed that optimization of Plasmodium genes for mammalian expression is an important aspect of vaccine design. Codon-optimization, surface-trafficking, de-glycosylation and removal of toxic domains can lead to improved immunogenicity. Understanding the vector's ability to induce an immune response and the expression of malaria antigens in mammalian cells will be critical in designing the next generation of viral-vectored malaria vaccines.

Adenoviridae↗
PubMed2001

Private investment in AIDS vaccine development: obstacles and solutions.

The development of vaccines for the prevention of AIDS, malaria, tuberculosis, and other diseases requires both public and private investment. Private investment, however, has been far lower than might have been hoped, given the massive human toll of these diseases, particularly in the poorest countries. With a view to understanding this situation and exploring potential solutions, the World Bank AIDS Vaccine Task Force commissioned a study on the perspectives of the biotechnology, vaccine, and pharmaceutical industries regarding investment in research and development work on an AIDS vaccine. It was found that different obstacles to the development of an AIDS vaccine arose during the product development cycle. During the earlier phases, before obtaining proof of product, the principal barriers were scientific. The lack of consensus on which approach was likely to be effective increased uncertainty and the risks associated with investing in expensive clinical trials. The later phases, which involved adapting, testing, and scaling up production for different populations, were most influenced by market considerations. In order to raise the levels of private research and development in an AIDS vaccine there will probably have to be a combination of push strategies, which reduce the cost and scientific risk of investment, and pull strategies, which guarantee a market.

AIDS Vaccines↗
PubMed2001

Considerations for combination vaccine development and use in the developing world.

As more vaccines are developed and become available, combination vaccines will provide a way of delivering multiple antigens to avoid multiple injections and complications in the regular immunization schedules. The advantages of combination vaccines are that they decrease the discomfort of vaccine recipients and parents and also reduce the delivery cost of vaccines. We address some of the issues related to the use of combination vaccines in the developing world. Which vaccines are needed? Do developing countries have the appropriate infrastructure to deliver them? Can vaccines become affordable for countries with low incomes? And what is really needed to achieve the goal of providing developing countries with new vaccines of epidemiologic significance in a timely fashion?

Americas↗
PubMed2005

Fundamental immunology and what it can teach us about HIV vaccine development.

This survey covers the immunological background to development of an HIV vaccine, starting from an overview of present understanding of the mechanisms of immunoregulation. It follows the uptake, processing and presentation of an antigen, from its initial uptake by a dendritic cell and its deposit on the dendrites of follicular dendritic cells. It pursues the antigen through uptake by B cells, presentation of epitopes to helper T cells and the eventual production of antibody. In the second arm of the immune response it follows synapse formation between dendritic cell and CD4/CD8 cells leading to production of CTL. It identifies epitope linkage as a key element in directing these pathways. It identifies the principal functions of the various types of cell cooperation. Continuing, it focuses on topics relevant to vaccine development: Th1/Th2 balance: new adjuvants based on ligands of TLRs and other activators of innate immunity, as well as new forms of intervention in antigen processing. We urge that the new vaccine fusion constructs be evaluated against a fusion gold standard rather than against antigen alone. These considerations open new strategies of HIV vaccine development. . Finally we urge that vaccine trials should include storage of individual DNA samples, in order to gain better understanding of the genetic parameters of vaccine efficacy.

AIDS Vaccines↗
PubMed2002

Molecular epidemiology of HIV-1 genetic forms and its significance for vaccine development and therapy.

Since their initial expansion in human beings roughly seven decades ago in central Africa, the HIV-1 pandemic strains have diversified extensively through mutation and recombination. 24 circulating genetic forms of the main HIV-1 group are presently recognised, including 11 subtypes or sub-subtypes and 13 circulating recombinant forms. New genetic forms are being introduced in different areas of the world, changing the molecular epidemiology of the infection. It is generally agreed that the control of the HIV-1 pandemic requires the development of vaccines that efficiently protect against the range of HIV-1 genetic forms. The introduction of effective antiretroviral therapies in areas of high HIV-1 prevalence may also contribute to the control of the pandemic, as has been documented in developed countries. Efficient targeting of the extensive genetic diversity of HIV-1 constitutes one of the major challenges in present efforts against the pandemic, although the significance of HIV-1 genetic forms for vaccine development and therapy remains to be defined.

AIDS Vaccines↗
PubMed2005

Obstacles and advances in SARS vaccine development.

The emergence of the severe acute respiratory syndrome (SARS) that resulted in a pandemic in 2003 spurred a flurry of interest in the development of vaccines to prevent and treat the potentially deadly viral infection. Researchers around the world pooled their scientific resources and shared early data in an unprecedented manner in light of the impending public health crisis. There are still large gaps in knowledge about the pathogenesis of this virus. While significant advances have been made in the development of animal models, the practicality of their use may be hampered by a lack of pathological similarity with human disease. Described here are issues related to progress in vaccine development and the obstacles that lie ahead for both researchers and regulatory agencies.

Animals↗
PubMed1988

The current status of cholera vaccine development and experience with cholera vaccine trials in volunteers.

In recent years notable advances have been made in the development of improved vaccines to prevent cholera. These new vaccines are administered orally to maximally stimulate intestinal secretory immunity. Killed vibrios, given in conjunction with purified B subunit or administered alone, in three spaced doses, caused no adverse reactions and have conferred significant protection in volunteer challenge studies and in field trials. Two attenuated mutants of V. cholerae, prepared by recombinant DNA techniques, CVD 103 and CVD 103-HgR are well-tolerated and elicit prominent immune responses and protective immunity after ingestion of a single oral dose. Other modern approaches being pursued include the development of auxotrophic strains and of modifying attenuated S. typhi strain Ty21a to express V. cholerae Inaba and Ogawa LPS antigens.

Administration, Oral↗
PubMed2006

Progress in tuberculosis vaccine development.

The first tuberculosis vaccine candidates have reached clinical testing. Novel subunit vaccine candidates aimed at boosting previous BCG-prime vaccination and novel viable attenuated vaccine candidates aimed at substituting BCG have both completed the preclinical stage. Despite these achievements, rational vaccine design against tuberculosis has not come to an end. Novel findings in basic immunology and microbiology will advance further improvements in vaccine development. These include the potential role of crosspriming to induce more potent T-cell responses, the role of memory T cells and regulatory T cells in sustaining or curtailing optimal immune responses, respectively, as well as the involvement of cytokines in T-cell migration to nonimmunologic tissue sites and in the generation of memory. Knowledge about basic mechanisms underlying optimum protection will not only have a direct impact on future vaccine design against tuberculosis but also help in the formulation of a set of biomarkers with predictive value for vaccine efficacy assessment.

Humans↗
PubMedDate not supplied

New approaches to vaccine development.

A survey of current approaches to the development of vaccines against enteric diseases illuminates several strategies for the rational design of mycobacterial vaccines. One approach is to identify virulence factors and, through the use of transposon-mediated gene inactivation, to produce mutants that lack these factors. Such a strategy can provide important information on antigens important to protection. Genetic deletion or modification of these virulence factors provides insight into both the mechanisms of pathogenesis and the possibilities for the development of live attenuated vaccines. Alternatively, individual antigens identified as important for protection by antibodies and T cells or by studies of pathogenesis can be introduced into other live vaccine vectors to generate multivaccine vehicles. Both approaches appear to be relevant and of possible use for the development of improved vaccines against tuberculosis.

Animals↗
PubMed1999

Helicobacter pylori vaccine development and use: a cost-effectiveness analysis using the Institute of Medicine Methodology.

BACKGROUND: Prophylactic vaccination has been suggested as a better strategy than antibiotics to control Helicobacter pylori infection. We evaluated the cost-effectiveness (CE) of H. pylori vaccine development and use in the United States and developing countries, using a method developed by the Institute of Medicine (IOM). METHODS: The IOM model includes costs of vaccine development, vaccination program, and averted medical treatments; morbidity and mortality prevented; expected efficacy and use; and proportion of disease that is vaccine-preventable. The model employs infant mortality equivalence (IME) to estimate disease burden; with IME, the societal cost of infection-related morbidity is expressed as equivalent to a specific rate of infant deaths. We tested model assumptions by univariate sensitivity analyses. RESULTS: In the United States, H. pylori vaccine would save 1,176 IME and would cost $58.71 million (1997 dollars) annually, yielding a CE ratio of $49,932 per IME; the health benefits would exceed all IOM-studied vaccines, even when efficacy dropped to 55%. H. pylori vaccine could be cost-saving if priced at less than $60 per course. In developing countries, H. pylori vaccine would rank unfavorably both in terms of health benefits (33,518 IME) and costs ($5,254 million). None of the changes in assumptions improved significantly the H. pylori vaccine's ranking relative to other IOM-studied vaccines. CONCLUSIONS: Compared to other vaccines evaluated in the IOM study, H. pylori vaccine warrants public resource allocation for accelerated development and use in the United States but not for use in developing countries.

Adolescent↗
PubMedDate not supplied

AIDS vaccine development: the long and winding road.

Development of a vaccine that provides sterilizing immunity against HIV infection remains an elusive goal, due primarily to the difficulty in generating neutralizing antibodies to primary HIV isolates. In lieu of a present solution to this problem, recent approaches to develop vaccines against HIV/AIDS have focused not on preventing infection outright, but on eliciting potent antiviral CD8+ T-cell responses to limit HIV replication in individuals who become infected after vaccination. Successful control of HIV replication in vivo, enabled by vaccine-elicited immune responses should, in turn, attenuate an individual's rate of progression to AIDS while reducing their likelihood of subsequently transmitting HIV. Recent pre-clinical evaluation of CTL-based vaccines in non-human primate models of AIDS has shown several different vaccine modalities (e.g. heterologous 'prime/boost' strategies such as DNA + recombinant viral vectors) to be capable of eliciting high-level cellular immune responses that are associated with limitation of virus replication and protection against disease following challenge with select pathogenic virus isolates. However, it is not currently known to what extent these protective effects, observed under optimal experimental conditions in select animal models, can be translated into relevant protection of humans against AIDS. In this article we discuss the promise, potential limitations, and scientific challenges that currently provide the context for efforts to develop and successfully employ a safe and effective AIDS vaccine.

AIDS Vaccines↗
PubMed2002

Bacterial proteomics and vaccine development.

Until recently, the development of vaccines for use in humans relied on the response to attenuated or whole-cell preparations, or empirically selected antigens. The post-genomic era holds the possibility of rational design of novel vaccines for important human pathogens. The discovery and development of these new vaccines is likely to be accomplished through integrated proteomic strategies. Although most proteomic studies are based on two-dimensional gel electrophoresis (2D-PAGE) as a separation technique, new methods have been developed within the past two years that provide complementary information concerning microbial protein expression. The 2D-PAGE technique in combination with Western blotting has been successfully applied in the discovery of antigens from Helicobacter pylori, Chlamydia trachomatis and Borrelia garinii. Two-dimensional semi-preparative electrophoresis has provided complementary information regarding membrane protein expression in a strain of H. pylori. Through two-dimensional liquid chromatography-tandem mass spectrometry, the most comprehensive information to date regarding protein expression in yeast was obtained. This technique may shortly become an important tool in vaccinology. This review of the current state of bacterial proteomics as applied in vaccinology presents analytical techniques for protein separation, proteomics without gels, reverse vaccinology, and functional approaches to the identification of virulence proteins in microbes.

Bacterial Proteins↗