Comparison of the bioactivity of reference preparations for assaying Bordetella pertussis toxin activity in vaccines by the histamine sensitisation and Chinese hamster ovary-cell tests: assessment of validity of expression of activity in terms of protein concentration

Vaccine ◽  
2002 ◽  
Vol 20 (29-30) ◽  
pp. 3535-3542 ◽  
Author(s):  
D Xing ◽  
R.Gaines Das ◽  
P Newland ◽  
M Corbel
Keyword(s):  
Chinese Hamster Ovary Cell ◽  
Pertussis Toxin ◽  
Bordetella Pertussis ◽  
Chinese Hamster Ovary ◽  
Protein Concentration ◽  
Chinese Hamster ◽  
Ovary Cell ◽  
Bordetella Pertussis Toxin

Effect of Gender, Race, and Parental Education on Immunogenicity and Reported Reactogenicity of Acellular and Whole-Cell Pertussis Vaccines

PEDIATRICS ◽  
1995 ◽  
Vol 96 (3) ◽  
pp. 584-587
Author(s):  
Cynthia Christy ◽  
Michael E. Pichichero ◽  
George F. Reed ◽  
Michael D. Decker ◽  
Edwin L. Anderson ◽  
...  
Keyword(s):  
Chinese Hamster Ovary Cell ◽  
Pertussis Vaccine ◽  
Pertussis Toxin ◽  
Chinese Hamster Ovary ◽  
Parental Education ◽  
Chinese Hamster ◽  
Ovary Cell ◽  
Whole Cell ◽  
Filamentous Hemagglutinin ◽  
Antibody Levels

Objective. To determine whether gender, race (black or white), or level of parental education influenced serologic responses or reporting of clinical reactions after immunization with acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. Methods. Healthy infants were prospectively randomized to receive one of 13 DTaP, Lederle DTP, or another DTP. Parents recorded the occurrence of adverse reactions for 2 weeks after each inoculation. Sera obtained before the first immunization and 1 month after the third immunization were analyzed for antibody to pertussis toxin, filamentous hemagglutinin, fimbriae, and pertactin (PRN). Chinese hamster ovary cell pertussis toxin neutralization assays were performed, and levels of agglutinating antibodies determined. Results. Prevaccination antibody levels did not differ by race, gender, or parental education. Postimmunization geometric mean titers (GMTs) were strongly and consistently associated with race. For both DTaP and DTP and for every included antigen, postimmunization GMTs were about twice as high for black as for white infants. Among DTaP recipients, these differences were significant for pertussis toxin, Chinese hamster ovary cell pertussis toxin neutralization assay, filamentous hemagglutinin, and agglutinins; among the much smaller sample of WCL recipients, the differences achieved or approached statistical significance for agglutinins, PRN, and fimbriae. These findings were confirmed by regression analyses that controlled for gender, parental education, study site, and preimmunization antibody level. Reported reactions were not correlated with parental education level and showed no material correlation with gender. Black infants were reported to have had more pain than white infants after receiving WCL and DTaP and were reported to be more fussy after receiving WCL. Conclusions. The consistently higher postimmunization GMTs among black infants seems to be a real finding for which we have no explanation; the infants did not significantly differ by race in vaccine assignment, preimunization antibody levels, age at immunization, or interval from immunization to phlebotomy. These observations should be confirmed and further evaluated in future pertussis vaccine trials. Reported differences by race in pain and fussiness after receiving WCL might reflect chance, differences by race in the occurrence of reactions, or differences by race in the reporting of reactions.

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