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Pertussis, also known as whooping cough, is an infection caused by the bacteria, Bordetella pertussis. It is characterized by initial symptoms of fever, sneezing, inflammation of the mucous membranes of the nose, dry cough, irritability, loss of appetite. Attacks of whooping, which consists of short coughs followed by long drawn inhalation of air and a whooping sound, then occur over two weeks. The disease resolves within several weeks to months. Vaccines to prevent pertussis have been developed, but may cause side effects. Acellular vaccines, which contain parts of the bacteria rather than the whole cell, have been shown to have minimal adverse effects. An acellular pertussis vaccine was developed to protect against pertussis; diphtheria, an infection with the bacteria Corynebacterium diphtheriae; and tetanus, an infection with the bacteria Clostridium tetani. This combined vaccine is referred to as the acellular pertussis-component diphtheria-pertussis-tetanus (APDT) vaccine. It is produced by the Japanese drug company Takeda Chemical Industries and the American drug company Lederle Laboratories. The effectiveness of the Lederle/Takeda APDT vaccine was compared with a diphtheria-pertussis-tetanus (DPT) vaccine containing whole cells of pertussis. The study involved 252 children who were vaccinated at two, four, and six months of age with the whole-cell vaccine; 245 received the acellular vaccine using the same schedule. All children were immunized with the acellular vaccine at 18 months of age. The incidence of adverse effects was lower among children initially immunized with the acellular vaccine compared with children given the whole cell vaccine. The severity of unfavorable vaccine-related side effects was reduced after the 18-month immunization in all children. The whole-cell and acellular types of vaccines differed in their abilities to produce certain immune responses. These findings show that the APDT causes fewer adverse side effects than the conventional whole-cell DPT vaccine. The relative protective effects of the two vaccines require further study. (Consumer Summary produced by Reliance Medical Information, Inc.)

Following widespread use of conjugate pneumococcal vaccine, Neisseria meningitidislikely will become the leading cause of bacterial sepsis and meningitis in US children. This report describes the safety and immunogenicity in US children of four consecutive doses of a meningococcal group C vaccine conjugated to CRM197via reductive amination (MnCC).

The safety of the combined oligosaccharide conjugate Haemophilus influenzae(Hib) type b (HbOC) and whole cell diphtheria-tetanus toxoids-pertussis (DTP) vaccine (Tetramune, HbOC-DTP; Lederle) in infancy was evaluated in 6644 recipients of this vaccine and compared with 3914 recipients of separate injections of whole cell DTP and HbOC vaccines when given as a three dose regimen to infants at 2, 4 and 6 months of age in each group. Of the total number of infants in the study, a subset of 1435 were enrolled into the study and then randomly assigned to recieve either the Hib-DPT combined vaccine or the separate components. This subset was used to assess local and systemic side effects which were evaluated utilizing telephone interviews 48 to 72 hours after vaccine. The remaining children in the study population were enrolled in a nonrandomized manner. For these children parents were offered the experimental Hib-DPT vaccine and refusers were given HbOC and DTP. Both of these groups of children as well as the randomized subset described above were used to assess rates of episodes of hospitalization, emergency room utilization and sudden infant death syndrome in HbOC-DTP recipients and children who received HbOC and DTP separately. Immunogenicity was evaluated in 123 children by collection of a single serum sample 30 days after the third dose of HbOC-DTP. The observed immunogenicity was comparable to that observed in other recent studies for HbOC and DTP component antigens. The profile of local and systemic side effects observed was virtually identical to that observed after DTP plus HbOC given separately. In initial analyses the Hib-DPT children appeared to have a higher rate of hospitalization for pneumonia than the children with separate shots. After further analyses including chart review, review of chest radiographs, and adjustment for age and season, this initial association was believed most probably to be a result of chance alone. The HbOC-DTP vaccine offers the convenience of a single combined vaccine offering protection against diphtheria, pertussis, Hib and tetanus without any substantial or significant change in safety or immunogenicity profile.

A double blind, randomized, controlled trial compared the safety and immunogenicity of an acellular pertussis vaccine formulated at Lederle using the Takeda acellular pertussis component combined with Lederle diphtheria and tetanus toxoids vaccines APDT, with the commercially available Japanese Takeda vaccine APDTTJ as a threedose series to 2, 4, and 6monthold children. Sera were analyzed for antibody to pertussis antigens Iymphocytosispromoting factor filamentous hemagglutinin 69kDa outer membrane protein pertussis agglutinogens neutralizing antibodies to LPF and to diphtheria and tetanus toxoids. Information concerning local reactions and systemic events were collected daily for 10 days postimmunization. The overall reaction rate was low for both groups. There were no reactions that contraindicated subsequent vaccine and no serious adverse events. For local reactions statistically significant differences between the groups were seen only for a greater incidence of induration in the APDT group at 2 months 12vs.0,P< 0.01, and at 4 months 8vs.0,P0.4 compared to the APDTTJ group. Of the few systemic reactions the only statistically significant difference between the vaccine groups was a greater incidence of fretfulness in the APDT group after the initial immunization 12vs.2,P0.05. There were no statistically significant differences in the immune response between the two vaccines at the 7month visit. We conclude that APDT is equivalent to the commercially available Takeda vaccine APDTTJ.