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.
RCT Entities:
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.
Authors: N C Salisch; A Izquierdo Gil; D N Czapska-Casey; L Vorthoren; J Serroyen; J Tolboom; E Saeland; H Schuitemaker; R C Zahn Journal: NPJ Vaccines Date: 2019-12-20 Impact factor: 7.344
Authors: Amy S Espeseth; Pedro J Cejas; Michael P Citron; Dai Wang; Daniel J DiStefano; Cheryl Callahan; Gregory O' Donnell; Jennifer D Galli; Ryan Swoyer; Sinoeun Touch; Zhiyun Wen; Joseph Antonello; Lan Zhang; Jessica A Flynn; Kara S Cox; Daniel C Freed; Kalpit A Vora; Kapil Bahl; Andrew H Latham; Jeffrey S Smith; Marian E Gindy; Giuseppe Ciaramella; Daria Hazuda; Christine A Shaw; Andrew J Bett Journal: NPJ Vaccines Date: 2020-02-14 Impact factor: 7.344
Authors: Daniel Simancas-Racines; Juan Va Franco; Claudia V Guerra; Maria L Felix; Ricardo Hidalgo; Maria José Martinez-Zapata Journal: Cochrane Database Syst Rev Date: 2017-05-18
Authors: Kathryn Patton; Shahin Aslam; Jim Lin; Li Yu; Stacie Lambert; Glenn Dawes; Mark T Esser; Jennifer Woo; Sylvia Janetzki; Anu Cherukuri Journal: Clin Vaccine Immunol Date: 2014-02-26
Authors: Seyhan Boyoglu-Barnum; Tatiana Chirkova; Sean O Todd; Thomas R Barnum; Kelsey A Gaston; Patricia Jorquera; Lia M Haynes; Ralph A Tripp; Martin L Moore; Larry J Anderson Journal: J Virol Date: 2014-07-02 Impact factor: 5.103