Special Issue "Vaccine Development Needs for Marburg Virus and Sudan Ebolavirus: Leveraging Lessons Learned from the Zaire Ebolavirus"

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Vaccines against Infectious Diseases".

Deadline for manuscript submissions: closed (30 June 2022) | Viewed by 2487

Special Issue Editors

Dr. Daniel Wolfe
E-Mail Website
Guest Editor
Biomedical Advanced Research and Development Authority, Department of Health and Human Services, Washington, DC 20201, USA
Interests: biodefense; vaccines; immunology; vaccine manufacturing; clinical trials
Dr. Kimberly L. Taylor
E-Mail Website
Guest Editor
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Washington, DC 20201, USA
Interests: vaccine development; biodefense pathogens and emerging infectious diseases; preclinical testing
Dr. Lawrence A. Wolfraim
E-Mail Website
Guest Editor
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Washington, DC 20201, USA
Interests: vaccine development; biodefense pathogens and emerging infectious diseases; preclinical testing; immunology; immune assays
Dr. Clint Florence
E-Mail Website
Guest Editor
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Washington, DC 20201, USA
Interests: animal model; vaccine and advanced product development; biodefense; immunology; microbiology

Special Issue Information

Dear Colleagues,

Since 2014, we have seen dramatic progress in the field of Ebola vaccines, largely driven by the urgent need associated with the 2014–2016 epidemic in West Africa. The collective efforts from the filovirus community resulted in vaccines moving from preclinical development to a licensed vaccine by the end of 2019. However, the licensed vaccine protects only against Zaire ebolavirus and other related viruses (specifically Sudan ebolavirus and Marburg virus) still pose urgent threats.

The recent outbreak of Marburg virus highlights the urgent need for vaccines that could be used to help slow the spread of disease when these outbreaks inevitably occur. It also casts a light on our collective level of preparedness in terms of available medical countermeasures.

In this Special Issue, we aim to cover lessons learned from the Zaire ebolavirus vaccine development, and how this can/will be applied to vaccine development for Sudan ebolavirus and Marburg virus. Topics will include perspectives from the USG and product developers on the development of Zaire ebolavirus vaccines, challenges and lessons learned, regulatory strategies, and updates of licensed or lead candidates. Other topics will include the development of standardized tools, such as available immunological assays and animal models, and clinical trial network operations during outbreaks. The goal is to provide an overview of the current status of Marburg virus and Sudan ebolavirus vaccines and some of the key enabling technologies.

Dr. Daniel Wolfe
Dr. Kimberly L. Taylor
Dr. Lawrence A. Wolfraim
Dr. Clint Florence
Guest Editors

Manuscript Submission Information

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Published Papers (3 papers)

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Research

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Article
A Cloned Recombinant Vesicular Stomatitis Virus-Vectored Marburg Vaccine, PHV01, Protects Guinea Pigs from Lethal Marburg Virus Disease
Vaccines 2022, 10(7), 1004; https://0-doi-org.brum.beds.ac.uk/10.3390/vaccines10071004 - 23 Jun 2022
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Abstract
Marburg virus (MARV) is a negative-sense, single-stranded RNA virus that belongs to the Filoviridae family. Despite having caused numerous outbreaks of severe hemorrhagic fever with high case fatality rates, there are still no clinically approved therapeutics or vaccines to treat or prevent MARV [...] Read more.
Marburg virus (MARV) is a negative-sense, single-stranded RNA virus that belongs to the Filoviridae family. Despite having caused numerous outbreaks of severe hemorrhagic fever with high case fatality rates, there are still no clinically approved therapeutics or vaccines to treat or prevent MARV disease. Recombinant vesicular stomatitis viruses (rVSVs) expressing heterologous viral glycoproteins have shown remarkable promise as live-attenuated vaccine vectors, with an rVSV-based Ebola virus vaccine having received regulatory approval in the United States and numerous other countries. Analogous rVSV vaccine vectors have also been developed for MARV and have shown efficacy in several preclinical studies conducted in nonhuman primates. Here, we used a guinea pig model to confirm the protective efficacy of a cloned, rVSV-based candidate vaccine, termed PHV01, expressing the MARV variant Angola glycoprotein. Our results demonstrated that a single dose (2 × 106 PFU) of vaccine administered 28 days prior to challenge with a uniformly lethal dose of guinea-pig-adapted MARV variant Angola provided complete protection from death and disease. Moreover, protection was robust, with as little as 200 PFU of vaccine conferring significant protection. Not only does this study highlight the potential predictive value of the guinea pig model in the evaluation of MARV countermeasures, but it also demonstrates consistent and reproducible protection afforded by a clonal vaccine candidate. Indeed, this study identifies PHV01 as a suitable vaccine candidate for advanced development. Full article
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Article
Natural History of Sudan ebolavirus to Support Medical Countermeasure Development
Vaccines 2022, 10(6), 963; https://0-doi-org.brum.beds.ac.uk/10.3390/vaccines10060963 - 16 Jun 2022
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Abstract
Sudan ebolavirus (SUDV) is one of four members of the Ebolavirus genus known to cause Ebola Virus Disease (EVD) in humans, which is characterized by hemorrhagic fever and a high case fatality rate. While licensed therapeutics and vaccines are available in limited number [...] Read more.
Sudan ebolavirus (SUDV) is one of four members of the Ebolavirus genus known to cause Ebola Virus Disease (EVD) in humans, which is characterized by hemorrhagic fever and a high case fatality rate. While licensed therapeutics and vaccines are available in limited number to treat infections of Zaire ebolavirus, there are currently no effective licensed vaccines or therapeutics for SUDV. A well-characterized animal model of this disease is needed for the further development and testing of vaccines and therapeutics. In this study, twelve cynomolgus macaques (Macaca fascicularis) were challenged intramuscularly with 1000 PFUs of SUDV and were followed under continuous telemetric surveillance. Clinical observations, body weights, temperature, viremia, hematology, clinical chemistry, and coagulation were analyzed at timepoints throughout the study. Death from SUDV disease occurred between five and ten days after challenge at the point that each animal met the criteria for euthanasia. All animals were observed to exhibit clinical signs and lesions similar to those observed in human cases which included: viremia, fever, dehydration, reduced physical activity, macular skin rash, systemic inflammation, coagulopathy, lymphoid depletion, renal tubular necrosis, hepatocellular degeneration and necrosis. The results from this study will facilitate the future preclinical development and evaluation of vaccines and therapeutics for SUDV. Full article
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Review

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Review
Vaccine Licensure in the Absence of Human Efficacy Data
Vaccines 2022, 10(3), 368; https://0-doi-org.brum.beds.ac.uk/10.3390/vaccines10030368 - 26 Feb 2022
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Abstract
Clinical vaccine development and regulatory approval generally occurs in a linear, sequential manner: Phase 1: safety, immunogenicity; Phase 2: immunogenicity, safety, dose ranging, and preliminary efficacy; Phase 3: definitive efficacy, safety, lot consistency; and following regulatory approval, Phase 4: post-marketing safety and effectiveness. [...] Read more.
Clinical vaccine development and regulatory approval generally occurs in a linear, sequential manner: Phase 1: safety, immunogenicity; Phase 2: immunogenicity, safety, dose ranging, and preliminary efficacy; Phase 3: definitive efficacy, safety, lot consistency; and following regulatory approval, Phase 4: post-marketing safety and effectiveness. For candidate filovirus vaccines, where correlates of protection have not been identified, and phase 2 and 3 efficacy of disease prevention trials untenable, large and/or protracted, each trial may span decades, with full licensure expected only after several decades of development. Given the urgent unmet need for new Marburg virus and Ebola Sudan virus vaccines, the Sabin Vaccine Institute hosted a key stakeholder virtual meeting in May 2021 to explore the possibility of licensure by use of an “animal rule-like” licensure process, based on a risk/benefit assessment specific to regional needs and informed by epidemiology. This may be appropriate for diseases where there are no or limited treatment options, and those prone to sporadic outbreaks with high rates of transmission, morbidity, and mortality. The discussion focused on two contexts: licensure within the Ugandan regulatory environment, a high burden country where Ebola vaccine trials are ongoing, and licensure by the United States FDA—a well-resourced regulatory agency. Full article
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