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Effectiveness of Non-Adjuvanted Pandemic Influenza A Vaccines for Preventing Pandemic Influenza Acute Respiratory Illness Visits in 4 U.S. Communities
Marie R. Griffin1,2*, Arnold S. Monto6, Edward A. Belongia7, John J. Treanor8, Qingxia Chen3, Jufu Chen10, H. Keipp Talbot2,4, Suzanne E. Ohmit6, Laura A. Coleman7, Gerry Lofthus8, Joshua G. Petrie6, Jennifer K. Meece7, Caroline Breese Hall8,9, John V. Williams4,5, Paul Gargiullo10, LaShondra Berman10, David K. Shay10, for the U.S. Flu-VE Network
1 Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 2 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 3 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 4 Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 5 Department of Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 6 Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States of America, 7 Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States of America, 8 Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America, 9 Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America, 10 Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
Abstract Top
We estimated the effectiveness of four monovalent pandemic influenza A (H1N1) vaccines (three unadjuvanted inactivated, one live attenuated) available in the U.S. during the pandemic. Patients with acute respiratory illness presenting to inpatient and outpatient facilities affiliated with four collaborating institutions were prospectively recruited, consented, and tested for influenza. Analyses were restricted to October 2009 through April 2010, when pandemic vaccine was available. Patients testing positive for pandemic influenza by real-time RT-PCR were cases; those testing negative were controls. Vaccine effectiveness was estimated in logistic regression models adjusted for study community, patient age, timing of illness, insurance status, enrollment site, and presence of high-risk medical conditions. Pandemic virus was detected in 1,011 (15%) of 6,757 enrolled patients. Fifteen (1%) of 1,011 influenza positive cases and 1,042 (18%) of 5,746 test-negative controls had record-verified pandemic vaccination >14 days prior to illness onset. Adjusted effectiveness (95% confidence interval) for pandemic vaccines combined was 56% (23%, 75%). Adjusted effectiveness for inactivated vaccines alone (79% of total) was 62% (25%, 81%) overall and 32% (−92%, 76%), 89% (15%, 99%), and −6% (−231%, 66%) in those aged 0.5 to 9, 10 to 49, and 50+ years, respectively. Effectiveness for the live attenuated vaccine in those aged 2 to 49 years was only demonstrated if vaccination >7 rather than >14 days prior to illness onset was considered (61%: 12%, 82%). Inactivated non-adjuvanted pandemic vaccines offered significant protection against confirmed pandemic influenza-associated medical care visits in young adults.
Citation: Griffin MR, Monto AS, Belongia EA, Treanor JJ, Chen Q, et al. (2011) Effectiveness of Non-Adjuvanted Pandemic Influenza A Vaccines for Preventing Pandemic Influenza Acute Respiratory Illness Visits in 4 U.S. Communities. PLoS ONE 6(8): e23085. doi:10.1371/journal.pone.0023085
Editor: Xia Jin, University of Rochester, United States of America
Received: May 26, 2011; Accepted: July 5, 2011; Published: August 12, 2011
Copyright: ? 2011 Griffin et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was funded by the Centers for Disease Control and Prevention through cooperative agreements with the Marshfield Clinic Research Foundation (U01 IP000183), the University of Michigan (U01 IP000170), the University of Rochester (U01 IP000172), and Vanderbilt University (U01 IP000184). Internal CDC funds were used to support CDC investigators and to provide laboratory validation of RT-PCR methods at the enrolling site laboratories. As part of the cooperative agreement, CDC investigators participated in study design, analysis, decision to publish and preparation of the manuscript. Dr. Talbot received salary support from the NIAID (1K23AI074863-01). The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
Competing interests: The authors have read the journal's policy and have the following conflicts: Marie R. Griffin received grant support from MedImmune and Pfizer (formerly Wyeth); Arnold S. Monto has been an ad hoc consultant to Baxter, CSL, GSK, Novartis, and sanofi-pasteur; John J. Treanor is an unpaid member of a data safety monitoring board for Novartis, and has received grant support for laboratory studies from GSK and Mercia Pharmam and for conducting clinical vaccine trials from CSL, Protein Sciences, Wyeth, Merck, and VaxInnate; H. Keipp Talbot received research support from Pfizer (Wyeth), Protein Sciences, sanofi-pasteur, and VaxInnate; Caroline Breese Hall has served as a consultant for MedImmune; John V. Williams has served as a consultant for MedImmune, Novartis, and Quidel. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials..
Marie R. Griffin1,2*, Arnold S. Monto6, Edward A. Belongia7, John J. Treanor8, Qingxia Chen3, Jufu Chen10, H. Keipp Talbot2,4, Suzanne E. Ohmit6, Laura A. Coleman7, Gerry Lofthus8, Joshua G. Petrie6, Jennifer K. Meece7, Caroline Breese Hall8,9, John V. Williams4,5, Paul Gargiullo10, LaShondra Berman10, David K. Shay10, for the U.S. Flu-VE Network
1 Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 2 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 3 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 4 Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 5 Department of Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America, 6 Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States of America, 7 Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States of America, 8 Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America, 9 Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America, 10 Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
Abstract Top
We estimated the effectiveness of four monovalent pandemic influenza A (H1N1) vaccines (three unadjuvanted inactivated, one live attenuated) available in the U.S. during the pandemic. Patients with acute respiratory illness presenting to inpatient and outpatient facilities affiliated with four collaborating institutions were prospectively recruited, consented, and tested for influenza. Analyses were restricted to October 2009 through April 2010, when pandemic vaccine was available. Patients testing positive for pandemic influenza by real-time RT-PCR were cases; those testing negative were controls. Vaccine effectiveness was estimated in logistic regression models adjusted for study community, patient age, timing of illness, insurance status, enrollment site, and presence of high-risk medical conditions. Pandemic virus was detected in 1,011 (15%) of 6,757 enrolled patients. Fifteen (1%) of 1,011 influenza positive cases and 1,042 (18%) of 5,746 test-negative controls had record-verified pandemic vaccination >14 days prior to illness onset. Adjusted effectiveness (95% confidence interval) for pandemic vaccines combined was 56% (23%, 75%). Adjusted effectiveness for inactivated vaccines alone (79% of total) was 62% (25%, 81%) overall and 32% (−92%, 76%), 89% (15%, 99%), and −6% (−231%, 66%) in those aged 0.5 to 9, 10 to 49, and 50+ years, respectively. Effectiveness for the live attenuated vaccine in those aged 2 to 49 years was only demonstrated if vaccination >7 rather than >14 days prior to illness onset was considered (61%: 12%, 82%). Inactivated non-adjuvanted pandemic vaccines offered significant protection against confirmed pandemic influenza-associated medical care visits in young adults.
Citation: Griffin MR, Monto AS, Belongia EA, Treanor JJ, Chen Q, et al. (2011) Effectiveness of Non-Adjuvanted Pandemic Influenza A Vaccines for Preventing Pandemic Influenza Acute Respiratory Illness Visits in 4 U.S. Communities. PLoS ONE 6(8): e23085. doi:10.1371/journal.pone.0023085
Editor: Xia Jin, University of Rochester, United States of America
Received: May 26, 2011; Accepted: July 5, 2011; Published: August 12, 2011
Copyright: ? 2011 Griffin et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was funded by the Centers for Disease Control and Prevention through cooperative agreements with the Marshfield Clinic Research Foundation (U01 IP000183), the University of Michigan (U01 IP000170), the University of Rochester (U01 IP000172), and Vanderbilt University (U01 IP000184). Internal CDC funds were used to support CDC investigators and to provide laboratory validation of RT-PCR methods at the enrolling site laboratories. As part of the cooperative agreement, CDC investigators participated in study design, analysis, decision to publish and preparation of the manuscript. Dr. Talbot received salary support from the NIAID (1K23AI074863-01). The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
Competing interests: The authors have read the journal's policy and have the following conflicts: Marie R. Griffin received grant support from MedImmune and Pfizer (formerly Wyeth); Arnold S. Monto has been an ad hoc consultant to Baxter, CSL, GSK, Novartis, and sanofi-pasteur; John J. Treanor is an unpaid member of a data safety monitoring board for Novartis, and has received grant support for laboratory studies from GSK and Mercia Pharmam and for conducting clinical vaccine trials from CSL, Protein Sciences, Wyeth, Merck, and VaxInnate; H. Keipp Talbot received research support from Pfizer (Wyeth), Protein Sciences, sanofi-pasteur, and VaxInnate; Caroline Breese Hall has served as a consultant for MedImmune; John V. Williams has served as a consultant for MedImmune, Novartis, and Quidel. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials..