Improving Evaluation of Bacterial Vaccines
Drusilla L. Burns, PhD
Office of Vaccines Research and Review
Division of Bacterial, Parasitic, and Allergenic Products
Laboratory of Respiratory and Special Pathogens
Biosketch
Dr. Drusilla Burns Dr. Burns received her Ph.D. in Biochemistry from the University of California, Berkeley and did postdoctoral training at NIH. After her postdoctoral work, she joined FDA. She is currently Deputy Director of the Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review at the Center for Biologics Evaluation and Research, FDA. Her lab conducts research in the areas of bacterial pathogenesis and host responses, with emphasis on the biochemistry and immunology of bacterial vaccines. In addition, she is involved in the regulation of bacterial vaccines, live biotherapeutic products, and allergenic products.
General Overview
CBER is responsible for ensuring that the vaccines that are made available to the public are safe, pure, potent, and effective. To carry out this responsibility, a solid understanding of the science of vaccines is required. The research in this Laboratory supports science-based regulation of bacterial vaccines, particularly toxoid-based vaccines, by building on the foundation of knowledge needed to ensure vaccine safety, purity, and potency. Our studies provide new scientific tools and knowledge that support the development, manufacturing, and clinical evaluation of bacterial vaccines.
Scientific Overview
Our research focuses on the study of bacterial protein toxins and virulence factors that, in inactivated forms, are included as components of bacterial vaccines. These studies examine protein structure/function relationships and mechanisms of action by which these virulence factors cause disease. Such studies help guide the regulatory review of the safety and efficacy of vaccines based on these factors. To better understand how these vaccines provide protection against disease, we also study host immune responses to these antigens and seek to determine which immune responses might correlate with vaccine-induced protection. Knowledge of both pathogenic mechanisms and host responses are essential for proper understanding of the features of vaccine antigens that are critical to ensure safe and effective vaccines.
Publications
- Vaccine 2018 Oct 15;36(43):6379-82
Improving the stability of recombinant anthrax protective antigen vaccine.
Verma A, Burns DL - PLoS One 2018 Mar 29;13(3):e0195342
Comparison of the immune response during acute and chronic Staphylococcus aureus infection.
Brady RA, Mocca CP, Plaut RD, Takeda K, Burns DL - MBio 2018 Feb 27;9(1):e00209-18
Role of the antigen capture pathway in the induction of a neutralizing antibody response to anthrax protective antigen.
Verma A, Ngundi MM, Price GA, Takeda K, Yu J, Burns DL - Vaccine 2017 Dec 18;35(51):7160-5
Towards replacement of the acellular pertussis vaccine safety test: Comparison of in vitro cytotoxic activity and in vivo activity in mice.
Wagner LD, Corvette LJ, Ngundi MM, Burns DL - Pharmeur Bio Sci Notes 2016;2015:97-114
Transferability study of CHO cell clustering assays for monitoring of pertussis toxin activity in acellular pertussis vaccines.
Isbrucker R, Daas A, Wagner L, Costanzo A - Pharmeur Bio Sci Notes 2016;2015:82-96
Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement.
Arciniega J, Wagner L, Prymula R, Sebo P, Isbrucker R, Descampe B, Chapsal JM, Costanzo A, Hendriksen C, Hoonaker M, Nelson S, Lidster K, Casey W, Allen D - Clin Vaccine Immunol 2016 May 6;23(5):396-402
Mechanistic analysis of the effect of deamidation on the immunogenicity of anthrax protective antigen.
Verma A, Ngundi MM, Burns DL - PLoS One 2015 Apr 22;10(4):e0124877
RNA-Seq analysis of the host response to Staphylococcus aureus skin and soft tissue infection in a mouse model.
Brady RA, Bruno VM, Burns DL