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Volume 334:341-349 February 8, 1996 Number 6 Next

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ABSTRACT

Background Concern about both safety and efficacy has made the use of whole-cell pertussis vaccines controversial. In some European countries, including Italy, the rate of vaccination against pertussis is low.

Methods We conducted a double-blind trial in Italy in which infants were randomly assigned to vaccination at two, four, and six months of age with an acellular pertussis vaccine together with diphtheria and tetanus toxoids (DTP); a DTP vaccine containing whole-cell pertussis (manufactured by Connaught Laboratories); or diphtheria and tetanus toxoids without pertussis (DT). The acellular DTP vaccine was either one containing filamentous hemagglutinin, pertactin, and pertussis toxin inactivated with formalin and glutaraldehyde (SmithKline Beecham) or one with filamentous hemagglutinin, pertactin, and genetically detoxified pertussis toxin (Chiron Biocine). Pertussis was defined as 21 days or more of paroxysmal cough, with infection confirmed by culture or serologic testing.

Results The efficacy of each vaccine, given in three doses, against pertussis was determined for 14,751 children over an average of 17 months, with cases included in the analysis if cough began 30 days or more after the completion of immunization. For both of the acellular DTP vaccines, the efficacy was 84 percent (95 percent confidence intervals, 76 to 89 percent for SmithKline DTP and 76 to 90 percent for Biocine DTP), whereas the efficacy of the whole-cell DTP vaccine was only 36 percent (95 percent confidence interval, 14 to 52 percent). The antibody responses were greater to the acellular vaccines than to the whole-cell vaccine. Local and systemic adverse events were significantly more frequent after the administration of the whole-cell vaccine. For the acellular vaccines, the frequency of adverse events was similar to that in the control (DT) group.

Conclusions The two acellular DTP vaccines we studied were safe, immunogenic, and efficacious against pertussis, whereas the efficacy of the whole-cell DTP vaccine was unexpectedly low.

Source Information

From the Laboratory of Epidemiology and Biostatistics (D.G., S.S., A.E.T., A.A., M.L.C., P.P.) and the Laboratory of Bacteriology and Medical Mycology (P.M., M.G.), Istituto Superiore di Sanità, Rome; the Department of Hygiene and Microbiology, University of Palermo, Palermo, Italy (A.G.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md. (W.C.B., D.L.K., S.G.F.W.).

Address reprint requests to Dr. Greco at the Laboratory of Epidemiology and Biostatistics, Istituto Superiore di Sanità, viale Regina Elena 299, 00161 Rome, Italy.

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