Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study.
We assessed whether trivalent live, cold-adapted influenza virus (CAIV-T) vaccine provides added protection when co-administered with trivalent inactivated influenza virus vaccine (TVV) in patients with chronic obstructive pulmonary disease (COPD). Subjects (N=2215) were randomly assigned to receive either TVV intramuscularly (IM) and CAIV-T intranasally (TC), or TVV and placebo (TP). The vaccines were well-tolerated. Efficacy of TC compared to TP was not statistically significant and was 0.16 for any influenza virus strain (95% confidence limit (CL): -0.22, 0.43), 0.26 for A (H3N2) virus (95% CL: -0.17, 0.53), and -0.05 for type B virus (95% CL: -1.13, 0.48). However, there was a possible advantage for TC over TP in reducing respiratory consequences of an influenza season measured by pulmonary function and symptoms at end of study.
Gorse
Geoffrey J
GJ
Department of Veterans Affairs, Medical Center, Saint Louis University, St. Louis, MO, USA. gorsegj@slu.edu
O'Connor
Theresa Z
TZ
Young
Stephen L
SL
Mendelman
Paul M
PM
Bradley
Suzanne F
SF
Nichol
Kristin L
KL
Strickland
James H
JH
Paulson
Daniel M
DM
Rice
Kathryn L
KL
Foster
Runi A
RA
Fulambarker
Ashok M
AM
Shigeoka
John W
JW
Kuschner
Ware G
WG
Goodman
Richard P
RP
Neuzil
Kathleen M
KM
Wittes
Janet
J
Boardman
Kathy D
KD
Peduzzi
Peter N
PN
D000281:Administration, Intranasal; D000368:Aged; D004196:Disease Outbreaks; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D007251:Influenza, Human / Q000453:epidemiology / Q000276:immunology*; D007273:Injections, Intramuscular; D008875:Middle Aged; D010919:Placebos; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000276:immunology*; D015203:Reproducibility of Results; D014481:United States / Q000453:epidemiology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*
D007252:Influenza Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated