A comparative trial of the reactogenicity and immunogenicity of Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids

Article Abstract:

In Japan, children are immunized against pertussis (whooping cough) with an acellular vaccine, which is usually given at two years of age. (The acellular vaccine contains a fraction of the whole pertussis component, which contains antigen and thus stimulates an antibody response.) Although the incidence of pertussis in Japan is low, a number of children younger than two years of age develop the disease each year. This study examined if younger children could be given the vaccine safely and if it would provide adequate protection against pertussis. The Takeda acellular pertussis vaccine was given to infants and children who had no prior history of pertussis vaccination or the disease itself. The children were monitored for any side effects, and the effectiveness of vaccination was evaluated by testing for antibody production. The children were categorized by age: 139 infants aged 3 to 8 months, 60 infants and children aged 9 to 23 months, and 99 children aged 24 to 30 months. A total of four doses were given. Results showed that after the fourth dose, there was a good antibody response toward pertussis toxin (PT) and filamentous hemagglutinin (FHA) in all groups. Initial PT antibody levels were 1.4, 1.1, and 1.1 enzyme-linked immunosorbent assay units per milliliter (EU/mL) for the 3- to 8-month group, the 9- to 23-month group, and the 24- to 30-month group, respectively. After the final dose was given, these levels increased to 67.8, 105.4, and 92.9 EU/mL. Between 28 and 38 percent of the vaccinated infants and children experienced minor side effects such as drowsiness or soreness at the injection site, but no major side effects occurred in response to vaccination. These results indicate that children as young as three months of age can safely be given the Takeda acellular pertussis vaccine and that it elicits an effective antibody response. Several tables describe antibody responses, seroconversion and reactions to vaccination. (Consumer Summary produced by Reliance Medical Information, Inc.)

Pertussis vaccines

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Protective efficacy of the Takeda acellular pertussis vaccine combined with diphtheria and tetanus toxoids following household exposure of Japanese children

Article Abstract:

A systematic trial of the efficacy of the Takeda acellular vaccine for the prevention of whooping-cough (pertussis) in Japanese children is described. This vaccine does not contain intact cells, but does contain cellular fragments which have been found to spur the development of immunity. In 1947 a vaccine containing whole-cells began to be used in Japan, and by the mid 1970s the disease was well under control. Concerns regarding the safety of the vaccine, and a shift of the normal time of administration from three months of age to two years have led to a marked decrease in pertussis vaccines in recent years. Starting in about 1979, epidemics of considerable size marked by severe problems and death occurred. In 1981 a new vaccine, which did not contain whole cells and was combined with vaccine against diphtheria and tetanus, began to be used in Japan. Epidemic pertussis is again under control in Japan; however, children under the usual age of inoculation (two years of age) remain at two- to threefold risk. The occurrence of pertussis was studied among 62 vaccinated children who were exposed at home and 62 unvaccinated children who were similarly exposed. Fifteen percent of inoculated children become ill following exposure, as compared with 76 percent of the children who did not receive immunization. All of the cases of children who had been immunized were mild and were not distinguishable from other upper respiratory tract infections. The study estimates that vaccination is effective in preventing typical pertussis in 98 percent of children, and is 81 percent effective against all pertussis-like symptoms. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Comparison of acellular and whole-cell pertussis-component DTP vaccines: a multicenter double-blind study in 4- to 6-year-old children

Article Abstract:

The DTP vaccine, used to inoculate children against diphtheria, pertussis and tetanus, has been highly successful in reducing the incidence of pertussis in the United States and has significantly lowered the death rate from this disease. However, the pertussis component of the vaccine has frequently produced adverse local and systemic reactions. Efforts have been made to formulate a DTP vaccine which will be effective, but will minimize these side effects. In Japan, six acellular pertussis component DTP vaccines (without pertussis cells) have been developed (APDT). The effects of this new APDT vaccine were compared with the older form of DTP vaccine currently licensed for use in the United States. Forty-one children received the APDT vaccine, and 42 received the DTP vaccine. The rate and severity of most common reactions were similar in the APDT and DTP vaccines; the reaction rates were low and the severity of reactions were mild. A greater percentage of the DTP recipients had reactions than did the APDT recipients, with the exception of fever symptoms. Prior studies have shown lower reaction rates for APDT vaccine than for DTP. Because reaction rates vary by lot, this factor may have influenced these results. Immune responses to the major antigens in the APDT vaccine were good. The children receiving the APDT vaccine had significantly less pain and warmth at the site of the injection than the DTP group. It was concluded that the APDT vaccine is less reactive than the DTP vaccine and produces good antibody responses in children. (Consumer Summary produced by Reliance Medical Information, Inc.)

Testing, Tetanus, Diphtheria, DPT vaccine, Diphtheria-tetanus-pertussis vaccines

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