A second generation acellular pertussis vaccine (component pertussis vaccine) containing purified pertussis toxin (PT) and filamentous haemagglutinin (FHA) was tested for its immunogenicity and safety in 2-month-old infants in comparison with first-generation acellular and whole-cell pertussis vaccines. At the ages of 2, 4, 6, and 18 months, respectively, 350 subjects were inoculated one dose of pertussis vaccine, which was combined with diphtheria and tetanus toxoids. Both acellular and component vaccines elicited significantly much fewer local and systemic reactions than whole-cell vaccine did. Besides, although not reaching statistical significance, the component vaccine was less reactogenic than the acellular vaccine. After each dose of the primary immunization, antibodies against PT and FHA were much higher in acellular and component pertussis vaccinees than in whole-cell vaccinees. However, at 18 months of age, just before the booster dose, both anti-PT and anti-FHA declined very close to, or even lower than, the prevaccination levels in all three groups and then responded rapidly to a booster dose to attain high levels. The booster responses were also significantly higher (P < 0.01)) in acellular and component groups than in whole-cell group. Component and acellular vaccines induced similar levels of anti-FHA but the former induced higher anti-PT than the latter (P < 0.01). Our results indicate that both in primary immunization and as a booster, acellular and component pertussis vaccines are much more immunogenic for PT and FHA and much less reactogenic than whole-cell vaccine. However, the persistence of anti-PT and anti-FHA was not as good as one can expect from other protein antigens without giving a booster dose. A long-term follow-up of the vaccinees has been underway to understand the persistence of these antibodies after the first booster.
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