U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Science & Research (Biologics)
  4. Biologics Research Projects
  5. Improving Vaccine Manufacturing Evaluation for Bacterial Respiratory Pathogens
  1. Biologics Research Projects

Improving Vaccine Manufacturing Evaluation for Bacterial Respiratory Pathogens

Principal Investigator: Drusilla L. Burns, PhD
Office / Division / Lab: OVRR / DBPAP / LRSP


General Overview

CBER is responsible for ensuring that the vaccines that are made available to the public are safe, pure, and potent. In order to do this, a solid understanding of the science of vaccines is required. Knowledge of both pathogenic mechanisms and host response is essential for proper regulation of vaccines since this knowledge allows us to identify the features of vaccine antigens that are critical to ensure safe and effective vaccines.

The research in this Laboratory Section supports the specific regulatory responsibilities of the individuals of the section which include review of pertussis, anthrax and Staphylococcal aureus vaccine regulatory submissions by providing us with knowledge about how Bordetella pertussis, Bacillus anthracis, and Staphylococcus aureus cause disease as well how the host immune response controls infection and disease.

These studies provide new scientific tools and knowledge required to support the manufacturing and clinical evaluation of pertussis, anthrax, and S. aureus vaccines. The program also develops and evaluates in-process tests and vaccine lot release tests, including stability tests, as well as clinical serological assays that measure antibody levels for evaluation of vaccines.


Scientific Overview

We use biochemical, genetic and molecular biological techniques to study pathogenesis and host response and to further characterize vaccine components, especially those for pertussis, anthrax, and S. aureus vaccines. We are also using these techniques to analyze and quantify the host immune response to infection and vaccination.

Primarily, these techniques include SDS polyacrylamide gel electrophoresis, immunoblot analysis, and recombinant DNA techniques to better understand the role of bacterial virulence factors-especially toxins and adhesins, in disease.

The program also develops and evaluates in-process tests and vaccine lot release tests, including stability tests, as well as clinical serological assays that measure antibody levels for evaluation of 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

 

Back to Top