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.
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.
Falsey
Ann R
AR
Department of Medicine, Rochester General Hospital, and University of Rochester School of Medicine, Rochester, NY 14621, USA. ann.falsey@viahealth.org
Walsh
Edward E
EE
Capellan
Jose
J
Gravenstein
Stefan
S
Zambon
Maria
M
Yau
Eddy
E
Gorse
Geoffrey J
GJ
Edelman
Robert
R
Hayden
Frederick G
FG
McElhaney
Janet E
JE
Neuzil
Kathleen M
KM
Nichol
Kristen L
KL
Simões
Eric A F
EA
Wright
Peter F
PF
Sales
Valérie M-P
VM
D000368:Aged; D000369:Aged, 80 and over; D000534:Alum Compounds / Q000737:chemistry / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018357:Respiratory Syncytial Virus Infections / Q000276:immunology* / Q000517:prevention & control; D022261:Respiratory Syncytial Virus Vaccines / Q000737:chemistry / Q000276:immunology*; D014481:United States
D000534:Alum Compounds; D022261:Respiratory Syncytial Virus Vaccines; C041524:aluminum sulfate