Objectives: Licensure of acellular pertussis vaccines awaits the completion of several ongoing efficacy trials. Results of these trials are dependent upon the laboratory procedures employed to diagnose Bordetella pertussis infection. Similarly, long-term surveillance of the pertussis immunization program requires the development and implementation of sensitive and specific diagnostic procedures. Licensure of less reactogenic acellular pertussis vaccines will provide an opportunity to immunize older age groups, however, data on pertussis morbidity in adults and the role of adults and adolescents in transmission are needed to make appropriate decisions on expanded use of these vaccines. To increase knowledge of pertussis diagnosis and epidemiology, the Laboratory has initiated projects: a) To develop laboratory procedures to diagnose infection with Bordetella pertussis. b) To determine which diagnostic procedures have the highest sensitivity and specificity for pertussis diagnosis at the different stages of illness. c) To apply these techniques to understand epidemiology of pertussis. FY94 Activities: 1. Performed a collaborative study with US Navy to determine the prevalence of B. pertussis infection in Marine recruits. Infection was evaluated by culture and serology and will be evaluated by polymerase chain reaction (PCR) technology following completion of final assay validation. Sample collection and culture was performed by the Navy medical staff on 156 subjects and about 1400 ELISA tests were performed by the Laboratory of Pertussis. From October 1993 through July 1994 samples were collected on recruits reporting to sick call with 7 or more days of cough. No subjects were positive by culture, however 2.5% of subjects met the serological case case definition for pertussis. 2. Evaluated and adapted published methods to detect B. pertussis infection using PCR methodolgy to determine the optimal procedure for samples collected in the Navy study. 3. Continued analysis of the data from a study in which the IgG and IgA antibodies to PT, FHA, pertactin, and fimbriae were measured in serum samples from 72 Japanese individuals with culture-confirmed pertussis.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Intramural Research (Z01)
Project #
1Z01BJ003010-02
Application #
3748124
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
1994
Total Cost
Indirect Cost