Document Detail

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.
MedLine Citation:
PMID:  18855558     Owner:  NLM     Status:  MEDLINE    
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 > or =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 > or =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.
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
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of infectious diseases     Volume:  198     ISSN:  0022-1899     ISO Abbreviation:  J. Infect. Dis.     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-10-15     Completed Date:  2008-12-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0413675     Medline TA:  J Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1317-26     Citation Subset:  AIM; IM    
Department of Medicine, Rochester General Hospital, and University of Rochester School of Medicine, Rochester, NY 14621, USA.
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MeSH Terms
Aged, 80 and over
Alum Compounds / chemistry,  pharmacology*
Double-Blind Method
Respiratory Syncytial Virus Infections / immunology*,  prevention & control
Respiratory Syncytial Virus Vaccines / chemistry,  immunology*
United States
Reg. No./Substance:
0/Alum Compounds; 0/Respiratory Syncytial Virus Vaccines; 10043-01-3/aluminum sulfate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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