title: Local reactions of Zwittergent-containing meningococcal vaccine after intramuscular injection in rats: comparison with the effect of diphtheria-pertussis-tetanus-polio vaccine.
abstract: A short-term toxicity study was performed to investigate local reactions and haematological changes after intramuscular (i.m.) injection of meningococcal vaccine with a concentration of 25 or 50 micrograms protein ml-1. In these meningococcal vaccines up to 75 micrograms Zwittergent ml-1 was used to form a protein-detergent complex with attractive immunogenic properties. The Zwittergent preparations were treated with NaOH in order to destroy any propane sultone residue and this was checked by HPLC. The effects were compared with those caused by a sterile phosphate-buffered saline solution and by diphtheria-pertussis-tetanus-polio (DPT-polio) vaccine. Groups of six male rats were injected i.m. with 0.25 ml of the test solution, on day 0 in the left, and on day 7 in the right, quadriceps muscle. On day 14 the animals were exsanguinated under ether anaesthesia and, after gross inspection, inguinal nodes were weighed. These lymph nodes and the left and right quadriceps muscles were studied microscopically. In addition, a haematological investigation was performed. A significant increase in the number of thrombocytes was seen in animals receiving the DPT-polio and meningococcal vaccines containing 25 micrograms protein ml-1, and an increase in the number of leucocytes, due to an increase of neutrophils and monocytes, was seen in animals receiving the DPT-polio and meningococcal vaccine containing 50 micrograms protein ml-1. In comparison with the DPT-polio vaccine (a product generally acceptable for use in man), the local inflammatory reaction in the muscles was less in rats injected with the meningococcal vaccines (especially in the 25 micrograms protein ml-1 group).(ABSTRACT TRUNCATED AT 250 WORDS)
mesh_terms: D000038:Abscess / Q000209:etiology; D000818:Animals; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D004338:Drug Combinations / Q000009:adverse effects; D006099:Granuloma / Q000209:etiology; D007273:Injections, Intramuscular; D007958:Leukocyte Count; D008198:Lymph Nodes / Q000276:immunology / Q000473:pathology; D008213:Lymphocyte Activation; D008297:Male; D009345:Neisseria meningitidis / Q000276:immunology*; D009929:Organ Size; D010567:Pertussis Vaccine / Q000009:adverse effects*; D010976:Platelet Count; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects*; D000644:Quaternary Ammonium Compounds; D051381:Rats; D011919:Rats, Inbred Strains; D013745:Tetanus Toxoid / Q000009:adverse effects*; D017778:Vaccines, Combined
chemical_list: C051021:DTPP vaccine; D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D004338:Drug Combinations; D010567:Pertussis Vaccine; D011054:Poliovirus Vaccine, Inactivated; D000644:Quaternary Ammonium Compounds; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; C034730:zwittergent 3-12