Comparison of the Safety and Immunogenicity of 2 Respiratory Syncytial Virus (RSV) Vaccines—Nonadjuvanted Vaccine or Vaccine Adjuvanted with Alum—Given Concomitantly with Influenza Vaccine to High-Risk Elderly Individuals

Journal of Infectious Diseases, Nov 2008

Background. Respiratory syncytial virus (RSV) has been recognized recently as an important adult pathogen. Methods. This randomized, double-blind, placebo-controlled study was designed to compare humoral responses to licensed trivalent influenza vaccine given concomitantly with 1 of 2 RSV vaccine formulations in persons ⩾65 years old with cardiopulmonary disease. Hemagglutinin-inhibition assays and neutralization assays were used to measure levels of antibody to influenza and RSV, respectively. Subjects with respiratory illnesses during subsequent winters were tested for RSV and influenza by reverse-transcriptase polymerase chain reaction and serologic analysis. Results. Neither RSV vaccine formulation had an effect on the humoral response to influenza vaccination, and both RSV vaccines were well tolerated by 1169 participants. The immunogenicity of the nonadjuvanted vaccine was judged superior on the basis of mean postvaccination neutralizing antibody titers (12.5 vs. 12.1) and the percentage of subjects for whom ⩾4-fold increases in neutralizing titer were observed when acute-phase and convalescent-phase serum samples were compared (168 [44%] of 383 vs. 129 [33%] of 400). In year 1, the percentage of illnesses due to RSV was 7% (36 of 492 illnesses) and that due to influenza was8%(40 of 492), compared with6%(11 of 189) due to RSV and 11% (20 of 189) due to influenza in year 2. The incidence of RSV infection was not significantly different in the RSV vaccine and placebo groups. Conclusions. Although the safety and immunogenicity data of these RSV vaccines are encouraging, low rates of infection make it challenging to design efficacy trials.

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Comparison of the Safety and Immunogenicity of 2 Respiratory Syncytial Virus (RSV) Vaccines—Nonadjuvanted Vaccine or Vaccine Adjuvanted with Alum—Given Concomitantly with Influenza Vaccine to High-Risk Elderly Individuals

Ann R. Falsey () 0 7 Edward E. Walsh 0 7 Jose Capellan 0 2 Stefan Gravenstein 0 5 6 Maria Zambon 0 4 Eddy Yau 0 2 Geoffrey J. Gorse 0 11 Robert Edelman 0 10 Frederick G. Hayden 0 12 Janet E. McElhaney 0 9 Kathleen M. Neuzil 0 14 Kristen L. Nichol 0 13 Eric A. F. Simes 0 8 Peter F. Wright 0 3 Valrie M.-P. Sales 0 1 0 Potential conflicts of interest: A.R.F. serves on the advisory board of Quidel, receives research grants from ADMA Biologics , and has been a consultant for sanofi pasteur, Merck, GlaxoSmithKline. E.E.W. receives research grants from Alnylam Biologics. V.M.-.P.S. was previously employed at sanofi pasteur. J.C. and E.Y. are currently employed by and own shares of sanofi pasteur. R.E. is a member of the sanofi pasteur speakers' bureau. J.E.M. has been a consultant for and received research support and/or honoraria from sanofi pasteur , Merck, and GlaxoSmithKline. S.G., M.Z., K.L.N., E.A.F.S., P.F.W., F.G.H., G.J.G., and K.M.N. report no relevant conflicts of interest Presented in part: 6th International RSV Symposium , Marco Island, Florida , 25-28 October 2007. Financial support: sanofi pasteur. Rochester General Hospital , 1425 Portland Avenue, Rochester, NY 14621 1 Division of Infectious Diseases, Department of Medicine, University Health Network 2 sanofi pasteur, Toronto, Canada 3 Departments of Pediatrics, Pathology, Microbiology, and Immunology, Vanderbilt University School of Medicine , Nashville, Tennessee 4 Health Protection Agency Centre for Infection , London, England, United Kingdom 5 Eastern Virginia Medical School , Norfolk 6 Department of Medicine, Brown University School of Medicine , Providence, Rhode Island 7 Department of Medicine, Rochester General Hospital, and University of Rochester School of Medicine , Rochester, New York 8 Department of Pediatrics, University of Colorado at Denver and Health Sciences Center , Denver, Colorado 9 Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut School of Medicine , Farmington, Connecticut 10 Department of Medicine and Center for Vaccine Development, University of Maryland School of Medicine , Baltimore, Maryland 11 St. Louis Department of Veterans Affairs Medical Center and Saint Louis University , St. Louis, Missouri 12 Divisions of Infectious Diseases and International Health, University of Virginia, School of Medicine , Charlottesville, Virginia 13 Department of Medicine, Minneapolis Veterans Administration Medical Center, University of Minnesota , Minneapolis, Minnesota 14 PATH and University of Washington School of Medicine , Seattle, Washington Background. Respiratory syncytial virus (RSV) has been recognized recently as an important adult pathogen. Methods. This randomized, double-blind, placebo-controlled study was designed to compare humoral responses to licensed trivalent influenza vaccine given concomitantly with 1 of 2 RSV vaccine formulations in persons 65 years old with cardiopulmonary disease. Hemagglutinin-inhibition assays and neutralization assays were used to measure levels of antibody to influenza and RSV, respectively. Subjects with respiratory illnesses during subsequent winters were tested for RSV and influenza by reverse-transcriptase polymerase chain reaction and serologic analysis. Results. Neither RSV vaccine formulation had an effect on the humoral response to influenza vaccination, and both RSV vaccines were well tolerated by 1169 participants. The immunogenicity of the nonadjuvanted vaccine was judged superior on the basis of mean postvaccination neutralizing antibody titers (12.5 vs. 12.1) and the percentage of subjects for whom 4-fold increases in neutralizing titer were observed when acute-phase and convalescent-phase serum samples were compared (168 [44%] of 383 vs. 129 [33%] of 400). In year 1, the percentage of illnesses due to RSV was 7% (36 of 492 illnesses) and that due to influenza was 8% (40 of 492), compared with 6% (11 of 189) due to RSV and 11% (20 of 189) due to influenza in year 2. The incidence of RSV infection was not significantly different in the RSV vaccine and placebo groups. Conclusions. Although the safety and immunogenicity data of these RSV vaccines are encouraging, low rates of infection make it challenging to design efficacy trials. - Respiratory syncytial virus (RSV) is recognized as the most important cause of lower respiratory tract illness in infants and young children [1]. Immunity to RSV is incomplete and reinfections occur throughout life [2, 3]. Although illness is generally mild in healthy young adults, RSV has been increasingly appreciated as an important cause of disease in elderly individuals and adults with cardiopulmonary diseases [4 7]. In these populations, RSV is second only to influenza A among pathogens responsible for serious viral respiratory infections [8]. Despite active research on vaccine development since discovery of the virus in the 1950s, an effective vaccine remains an elusive goal [9, 10]. Although all adults have (...truncated)


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Ann R. Falsey, Edward E. Walsh, Jose Capellan, Stefan Gravenstein, Maria Zambon, Eddy Yau, Geoffrey J. Gorse, Robert Edelman, Frederick G. Hayden, Janet E. McElhaney, Kathleen M. Neuzil, Kristen L. Nichol, Eric A. F. Simões, Peter F. Wright, Valérie M.-P. Sales. Comparison of the Safety and Immunogenicity of 2 Respiratory Syncytial Virus (RSV) Vaccines—Nonadjuvanted Vaccine or Vaccine Adjuvanted with Alum—Given Concomitantly with Influenza Vaccine to High-Risk Elderly Individuals, Journal of Infectious Diseases, 2008, pp. 1317-1326, 198/9, DOI: 10.1086/592168