DTaP vaccines from North American vaccine (NAVA): Composition and criticalparameters

NAVA's acellular pertussis vaccine is based on highly purified pertussis to xin (PT) inactivated with H2O2. PT was analysed using advanced biochemical methodology including mass spectroscopy (LC/MS), yielding mass and peptide mapping information on the subunits. Pertactin, adenylate cyclase, and Fim 1, 2 were below detection levels and only trace amounts of filamentous haem agglutinin (FHA) have been identified as a minor impurity. The vaccine does not induce anti-FHA antibodies during the course of a 3-dose primary immun ization series in infants. B and T cell epitopes are preserved to a higher extent after H2O2 detoxification when compared with chemical inactivation w ith formaldehyde, thus providing new information explaining why vaccines em ploying formaldehyde detoxified PT may need additional pertussis components added to induce high levels of protection. Anti-PT antibodies generated by NAVA diphtheria, tetanus, and acellular pertussis vaccine (DTaP) showed a positive correlation with protection against WHO-defined pertussis. The saf ety profiles for these vaccines showed low reactogenicity with no serious a dverse events due to the vaccines; (C) 1999 The International Association f or Biologicals.