LaToya Jones Braun

Regis University

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Dexiang Chen

The First People's Hospital of Changde

Shalimar Perkins

Program for Appropriate Technology in Health

Theodore W. Randolph

University of Colorado Boulder

Anil K. Tyagi

Mankind Pharma (India)

John F. Carpenter

University of Montana

Debra Kristensen

Aarhus University Hospital

Mark Guy

Program for Appropriate Technology in Health

David Sylvester

Doctors Company (United States)

Christine Feltman

Regis University

Christina Vessely

University of Colorado Anschutz Medical Campus

Cooperative Institutions

Louisiana State University Health Sciences Center Shreveport

Louisiana State University Health Sciences Center New Orleans

Regis University

University of Colorado Denver

Louisiana State University

University of Colorado Boulder

Louisiana State University in Shreveport

Program for Appropriate Technology in Health

Oregon Health & Science University

University of Colorado Health

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Freezing-Induced Perturbation of Tertiary Structure of a Monoclonal Antibody

Journal of Pharmaceutical Sciences (2014)

Lu Liu LaToya Jones Braun Wei Wang Theodore W. Randolph John F. Carpenter

Protein tertiary structure

Limiting

10.1002/jps.24013

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Citations (45)

Development of an Integrated Immunology and Vaccines Pharmacy Elective

INNOVATIONS in pharmacy (2017)

Stephanie James LaToya Jones Braun Christine Feltman R. C. Haight

Objective: To describe an elective course on immunology and vaccines for pharmacy students that extends beyond basic immunization training. Design: A three credit-hour Immunology and Vaccines elective was developed and taught by an immunologist, policy research expert, and pharmacist. The learning objectives of the course included: understanding how the immune system works with vaccines to provide protection against infectious diseases, the history and policies involved in immunization practice, and how to counsel the vaccine hesitant individual. Classes were conducted using a variety of formats; group projects, lectures, films, literature reviews and guest speakers. An end-of-course evaluation was used to gauge student opinion on course value. Students were evaluated by four exams and a final group presentation. Conclusion: Students indicated that this course was valuable to their future pharmacy careers and provided insight into why people choose not to vaccinate and how they could use the course insight to properly educate such individuals. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties Type: Note

Presentation (obstetrics)

10.24926/iip.v8i3.526

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Citations (1)

Evaluation of chemical degradation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry

Journal of Pharmaceutical Sciences (2008)

Tia Estey Christina Vessely Theodore W. Randolph Ian R. Henderson LaToya Jones Braun

Deamidation

10.1002/jps.21543

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Citations (28)

Freeze-thaw stress of Alhydrogel® alone is sufficient to reduce the immunogenicity of a recombinant hepatitis B vaccine containing native antigen

Vaccine (2014)

Tanya Clapp Michael W. Munks Ruchit Trivedi Uday B. Kompella LaToya Jones Braun

Vaccine efficacy

10.1016/j.vaccine.2014.05.037

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Citations (25)

List of contributors

Elsevier eBooks (2023)

Joseph Aabye Magid Abdo John P. Adelman Varsha Allampalli Hanna Almoaswes

10.1016/b978-0-323-98814-8.00031-7

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A heat-stable hepatitis B vaccine formulation

Human Vaccines (2009)

Jan Ježek Dexiang Chen Lynne Watson J.S. Crawford Shalimar Perkins

AbstractThe purpose of the present study was to develop a formulation of recombinant hepatitis B vaccine with improved stability at elevated temperatures. A validated, in vitro, antigen reactivity assay was used to measure the stability of the vaccine. The formulation development focused on modification of the interactions between the antigen and aluminum hydroxide adjuvant and subsequent optimization of the ionic aqueous environment of the adsorbed vaccine. A formulation of hepatitis B vaccine containing 40 mM histidine and 40 mM phosphate at pH 5.2 had considerably improved stability at elevated temperatures as measured by the in vitro antigen reactivity assay. The formulation exhibited 9-week stability at 55°C and was subsequently shown to be stable both at 37°C and at 45°C for at least 6 months based on the in vitro antigen reactivity and immunogenicity in mice. The formulation comprises only excipients which have a history of safe use in approved drug products. The new vaccine formulation has the potential to be used outside the cold chain for part of its shelf life. This may improve the immunization coverage, simplify the logistics for outreach immunization, and ensure the potency of the vaccine in areas where the cold chain is insufficient.

Hepatitis B vaccine

Antigenicity

10.4161/hv.5.8.8600

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Citations (36)

Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine

Journal of Pharmaceutical Sciences (2008)

Amber L. Clausi Jessica Cummiskey Scott Merkley John F. Carpenter LaToya Jones Braun

Excipient

10.1002/jps.21390

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Citations (50)

Characterization of the freeze sensitivity of a hepatitis B vaccine

Human Vaccines (2009)

Dexiang Chen Anil K. Tyagi John Carpenter Shalimar Perkins David Sylvester

Recent studies have revealed that vaccines containing aluminum adjuvant are exposed to sub-zero temperatures while in the cold chain more frequently than was previously believed. This raises concerns that these freeze-sensitive vaccines may be damaged and offer inadequate protection. This study was undertaken to characterize the immediate qualitative changes of one such vaccine, hepatitis B, caused by freeze exposure. Hepatitis B vaccine was subjected to freezing temperatures ranging from 0 degrees C to -20 degrees C for up to three episodes with durations ranging from 1 hour to 7 days. The vaccine was analyzed for freezing point, particle size distribution, tertiary structure, and in vitro and in vivo potency. Whether or not hepatitis B vaccine freezes was shown to be dependent on an array of factors including temperature, rate of temperature change, duration of exposure, supercooling effects and vibration. Vaccine exposed to "mild" freezing (-4 degrees C or warmer) temperatures did not freeze and remained qualitatively unaltered. Single or repeated freezing events at temperatures of -10 degrees C or lower were associated with aggregation of the adjuvant-antigen particles, structural damage of the antigen, and reduction of immunogenicity in mice. Damage to the vaccine increased with duration of freezing, lower temperature, and the number of freezing episodes. With vibration, vaccine froze at -6 degrees C after 1 hour and damage occurred. Freezing and freeze damage to vaccines containing aluminum salt adjuvant represent real risks to the effectiveness of immunization and should be prevented by strengthening the cold chain system or, alternatively, development of freeze-stable vaccine formulations.

Hepatitis B vaccine

10.4161/hv.5.1.6494

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Citations (70)

Vaccines with Aluminum-containing Adjuvants: Optimizing Vaccine Efficacy and Thermal Stability

Journal of Pharmaceutical Sciences (2010)

Tanya Clapp Paul D. Siebert Dexiang Chen LaToya Jones Braun

Heat stability

10.1002/jps.22284

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Citations (133)

Development of a freeze-stable formulation for vaccines containing aluminum salt adjuvants