Efficacy of an Acellular Pertussis Vaccine among Adolescents and Adults
Joel I. Ward, M.D., James D. Cherry, M.D., Swei-Ju Chang, M.S., Susan Partridge, R.N., M.B.A., Hang Lee, Ph.D., John Treanor, M.D., David P. Greenberg, M.D., Wendy Keitel, M.D., Stephen Barenkamp, M.D., David I. Bernstein, M.D., Robert Edelman, M.D., Kathryn Edwards, M.D., for the APERT Study Group
Background Pertussis immunization of adults may be necessaryto improve the control of a rising burden of disease and infection.This trial of an acellular pertussis vaccine among adolescentsand adults evaluated the incidence of pertussis, vaccine safety,immunogenicity, and protective efficacy.
MethodsBordetella pertussis infections and illnesses were prospectivelyassessed in 2781 healthy subjects between the ages of 15 and65 years who were enrolled in a national multicenter, randomized,double-blind trial of an acellular pertussis vaccine. Subjectsreceived either a dose of a tricomponent acellular pertussisvaccine or a hepatitis A vaccine (control) and were monitoredfor 2.5 years for illnesses with cough that lasted for morethan 5 days. Each illness was evaluated with use of a nasopharyngealaspirate for culture and polymerase-chain-reaction assay, andserum samples from patients in both acute and convalescent stagesof illness were analyzed for changes in antibodies to nine B.pertussis antigens.
Results Of the 2781 subjects, 1391 received the acellular pertussisvaccine and 1390 received the control vaccine. The groups hadsimilar ages and demographic characteristics, and the medianduration of follow-up was 22 months. The acellular pertussisvaccine was safe and immunogenic. There were 2672 prolongedillnesses with cough, but the incidence of this nonspecificoutcome did not vary between the groups, even when stratifiedaccording to age, season, and duration of cough. On the basisof the primary pertussis case definition, vaccine protectionwas 92 percent (95 percent confidence interval, 32 to 99 percent).Among unimmunized controls with illness, 0.7 percent to 5.7percent had B. pertussis infection, and the percentage increasedwith the duration of cough. On the basis of other case definitions,the incidence of pertussis in the controls ranged from 370 to450 cases per 100,000 person-years.
Conclusions The acellular pertussis vaccine was protective amongadolescents and adults, and its routine use might reduce theoverall disease burden and transmission to children.
Source Information
From the UCLA Center for Vaccine Research, Research and Education Institute, Harbor–UCLA Medical Center, David Geffen School of Medicine, UCLA, Torrance, Calif. (J.I.W., J.D.C., S.-J.C., S.P., H.L.); University of Rochester, Rochester, N.Y. (J.T.); University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh (D.P.G.); Baylor College of Medicine, Houston (W.K.); Saint Louis University, St. Louis (S.B.); Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (D.I.B.); Department of Medicine and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore (R.E.); and the Pediatric Clinical Research Office, Vanderbilt University Medical Center, Nashville (K.E.).
Address reprint requests to Dr. Ward at the UCLA Center for Vaccine Research, LA Biomed, Harbor–UCLA Medical Center, David Geffen School of Medicine, UCLA, Torrance, CA 90502.
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