Biodefense and Special Pathogen Vaccines

Pittman, Phillip R.; Plotkin, Stanley А.

doi:10.1016/b978-0-323-35761-6.00012-2

Cited by 5 publications

(4 citation statements)

References 267 publications

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“…Currently, in addition to military researchers, there are several groups involved in developing new-generation vaccines against tularemia, both by applying new technologies and by using different routes of administration [ 588 ]. In particular, attempts are focused on creating new live attenuated mutants [ 589 , 590 ], novel subunit vaccines [ 591 ] or glycoconjugate of lipopolysaccharide O antigen of F. tularensis [ 592 ].…”

Section: Biological Agents For Bio-warfare/bioterrorism Category A–bmentioning

confidence: 99%

A Historical Review of Military Medical Strategies for Fighting Infectious Diseases: From Battlefields to Global Health

Biselli

Nisini

Lista³

et al. 2022

Biomedicines

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The environmental conditions generated by war and characterized by poverty, undernutrition, stress, difficult access to safe water and food as well as lack of environmental and personal hygiene favor the spread of many infectious diseases. Epidemic typhus, plague, malaria, cholera, typhoid fever, hepatitis, tetanus, and smallpox have nearly constantly accompanied wars, frequently deeply conditioning the outcome of battles/wars more than weapons and military strategy. At the end of the nineteenth century, with the birth of bacteriology, military medical researchers in Germany, the United Kingdom, and France were active in discovering the etiological agents of some diseases and in developing preventive vaccines. Emil von Behring, Ronald Ross and Charles Laveran, who were or served as military physicians, won the first, the second, and the seventh Nobel Prize for Physiology or Medicine for discovering passive anti-diphtheria/tetanus immunotherapy and for identifying mosquito Anopheline as a malaria vector and plasmodium as its etiological agent, respectively. Meanwhile, Major Walter Reed in the United States of America discovered the mosquito vector of yellow fever, thus paving the way for its prevention by vector control. In this work, the military relevance of some vaccine-preventable and non-vaccine-preventable infectious diseases, as well as of biological weapons, and the military contributions to their control will be described. Currently, the civil–military medical collaboration is getting closer and becoming interdependent, from research and development for the prevention of infectious diseases to disasters and emergencies management, as recently demonstrated in Ebola and Zika outbreaks and the COVID-19 pandemic, even with the high biocontainment aeromedical evacuation, in a sort of global health diplomacy.

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Section: Biological Agents For Bio-warfare/bioterrorism Category A–bmentioning

confidence: 99%

A Historical Review of Military Medical Strategies for Fighting Infectious Diseases: From Battlefields to Global Health

Biselli

Nisini

Lista³

et al. 2022

Biomedicines

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“…The RML-derived Q58-A WCV was used as an investigational new drug (US BB-IND-26) [30] following on-site clinical trials and was manufactured by the National Drug Company (Philadelphia, PA, USA). Currently, the only licensed vaccine available, Q-Vax®(Seqirus UK Limited, Maidenhead, UK), is an iteration of the RML WCV.…”

Section: A Brief History Of Q Fever Vaccine Developmentmentioning

confidence: 99%

Q Fever Vaccine Development: Current Strategies and Future Considerations

Long

2021

Pathogens

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Q fever is a zoonotic disease caused by the intracellular pathogen Coxiella burnetii. This disease typically manifests as a self-limiting, febrile illness known as acute Q fever. Due to the aerosol transmissibility, environmental persistence, and infectivity of C. burnetii, this pathogen is a notable bioterrorism threat. Despite extensive efforts to develop next-generation human Q fever vaccines, only one vaccine, Q-Vax®, is commercially available. Q-Vax® is a phase I whole-cell vaccine, and its licensed use is limited to Australia, presumably due to the potential for a post-vaccination hypersensitivity response. Pre-clinical Q fever vaccine development is a major area of interest, and diverse approaches have been undertaken to develop an improved Q fever vaccine. Following a brief history of Q fever vaccine development, current approaches will be discussed along with future considerations for an improved Q fever vaccine.

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“…Pursuit of full licensure has been hampered by concerns regarding potential vaccine strain reversion to wild type (though this has not been documented in clinical studies), purported challenges for vaccine manufacture at commercial scale, and lack of a commercial partner. In the absence of an alternative candidate in clinical development, USAMRIID has continued to vaccinate laboratory workers at risk for occupational Francisella exposure under the Special Immunizations Program (SIP) (Pittman and Plotkin, 2018). The SIP was maintained for several decades at USAMRIID and vaccinated workers from numerous biocontainment laboratories in the US working on F. tularensis and other select agents.…”

Section: Introductionmentioning

confidence: 99%

Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in healthy research laboratory workers

Saunders,

Pierson,

Haller

et al. 2024

Front. Bacteriol.

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BackgroundTularemia is caused by the intracellular bacterium Francisella tularensis (Ft). It was weaponized historically due to low infectious aerosol dose, high morbidity, and mortality rates for pneumonic disease. The US Army developed the attenuated Live Vaccine Strain (LVS) from stocks provided by the former Soviet Union in the 1950s. The vaccine has been safe and immunogenic over the ensuing decades in multiple clinical trials including human challenge studies.MethodsTwo sequential FDA-regulated, non-randomized, single-arm LVS trials enrolled at-risk laboratory personnel working on tularemia in bio-containment laboratories under IND#157. Volunteers received a single dose of LVS manufactured in 1962 by scarification. Positive immunization was based on local scarification site “take reaction,” and either a >1:20 tularemia antigen microagglutination (MA) titer (protocol FY03-24; 2004-8) or >4-fold rise in MA titer (protocol FY07-15; 2009-2017). Those still negative by week 4 were offered a second dose.ResultsThe LVS vaccine was safe, well tolerated, and highly immunogenic. Between the two studies, all recipients (100%) had positive “take reactions,” with 95.5% of those in study FY03-24 having a positive response following initial vaccination. All but three subjects (98%) in protocol FY03-24 had positive MA titer results defined as >1:20, most within 28–35 days. In protocol FY07-15, 95% of subjects had a 4-fold or greater rise in MA titer, the primary immunogenicity endpoint for that study.DiscussionLVS vaccine administered to laboratory workers at risk for tularemia exposure over 12 years was safe and highly immunogenic. Response rates remained robust despite the vaccine lots employed having been manufactured 42–55 years prior to vaccination. The results and historical comparator data presented here serve as a benchmark for future studies. LVS remains unlicensed due to instability in culture and the potential for reversion to the wild-type pathogen. Despite the threat, there are no FDA-approved vaccines. In the absence of a clinical-stage commercial development effort, an ongoing LVS vaccine protocol under investigational new drug (IND) application for at-risk laboratory workers to prevent occupationally acquired disease should be considered based on extensive favorable data for this vaccine.Clinical trial registrationClinicalTrials.gov, identifiers NCT00584844 (trial FY03-24) and NCT00787826 (trial FY07-15).

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Biodefense and Special Pathogen Vaccines

Cited by 5 publications

References 267 publications

A Historical Review of Military Medical Strategies for Fighting Infectious Diseases: From Battlefields to Global Health

A Historical Review of Military Medical Strategies for Fighting Infectious Diseases: From Battlefields to Global Health

Q Fever Vaccine Development: Current Strategies and Future Considerations

Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in healthy research laboratory workers

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