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.
Bibliographical noteFunding Information:
The study was supported by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development, and by MedImmune Vaccines Inc. (formerly Aviron) (Mountain View, CA). The authors thank Maurice A. Mufson (M.D.), Robert F. Betts (M.D.), John J. Treanor (M.D.), Karen Welty-Wolf (M.D.), Genell Knatterud (Ph.D.), Joel I. Verter (Ph.D.), and Sylvan Wallenstein (Ph.D.), for their service on the Data and Safety Monitoring Board for the study; T. Michael Kashner (Ph.D., J.D.), Dominick Iacuzio (Ph.D.), Linda C. Lambert (Ph.D.), and Nancy A. Morgan (R.Ph., M.B.A.) for their service on the Executive Committee for the study; John R. Feussner (M.D.), for his guidance and leadership; Frances K. Newman (M.S.), Mahendra D. Mandava, Tobin Brosnahan, and B. Brandt Gormley for technical assistance at the central laboratory; Esther E. Otto (R.N., M.S.N.), for leading the efforts of the study coordinators; Joseph N. Vitale (M.S.), and Janett Nabors for data analysis assistance and statistical programming; Irma Haddock and Shahrzad Hojjat for centralized data review and editing; and the study coordinators, staff, and study subjects at the 20 study sites. The 20 VA Medical Center study sites and the principal investigators at the sites were, respectively: Ann Arbor, MI, Suzanne F. Bradley (M.D.); Bay Pines, FL, Lynn P. Anderson (M.D.); Birmingham, AL, James H. Strickland Jr. (M.D.); Boston, MA, Richard P. Goodman (M.D.); Cleveland, OH, James Finley (M.D.); Dallas, TX, Naiel N. Nassar (M.D.); Dayton, OH, Jack M. Bernstein (M.D.); Durham, NC, Stephen L. Young (M.D.); Gainesville, FL, Runi A. Foster (M.D.); Houston, TX, Jerome E. Stasek Jr. (M.D.); Long Beach, CA, Rodney M. Wishnow (M.D.); Minneapolis, MN, Kathryn Rice (M.D.); North Chicago, IL, Ashok Fulambarker (M.D.); Palo Alto, CA, Ware G. Kuschner (M.D.); Richmond, VA, Daniel M. Paulson (M.D.); Salt Lake City, UT, John W. Shigeoka (M.D.); San Juan, Puerto Rico, William Rodriguez (M.D.); Sepulveda, CA, Michael Littner (M.D.); St. Louis, MO, Rodney Lusk (M.D.); and Tucson, AZ, Michael P. Habib (M.D.). The Study Chairman was Geoffrey J. Gorse (M.D.), and the study biostatistician was Theresa Z. O’Connor (Ph.D.).
- Influenza vaccine
- Influenza virus