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Vaccine
Available online 13 March 2013
In Press, Uncorrected Proof ? Note to users
Cover image
Evaluation and sensitivity analysis of the effectiveness of unadjuvanted A(H1N1)pdm09 vaccine in hospital workers using multi-center cohort study in Korea
J. Lima,
B. Choib,
J. Kimc,
J. Kimd,
C. Kime,
J. Parkf,
H. Yoong,
S. Hongh,
J. Seob,
M. Kia, Corresponding author contact information, E-mail the corresponding author
a Department of Preventive Medicine, Eulji University School of Medicine, 143-5, Yongdu-dong, Jung-gu, Daejeon, Republic of Korea
b Department of Preventive Medicine, Hanyang University Medical School, 222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea
c Department of Pediatrics, Chonbuk National University Medical School, 567, Baekjedae-ro, Deokjin-gu, Jeonju, Jeonbuk, Republic of Korea
d Department of Laboratory Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, 38, Bangtong-gil, Sacheon-myeon, Gangneug, Gangwon-do, Republic of Korea
e Department of Pediatrics, Soonchunhyang University Bucheon Hospital, 170, Jomaru-ro, Wonmi-gu, Bucheon, Gyeonggi-do, Republic of Korea
f Department of Pediatrics, Soonchunhyang University Hospital, 31, Soonchunhyang 6-gil, Dongnam-gu, Cheonan, Chungcheongnam-do, Republic of Korea
g Division of Infectious diseases, Department of Internal Medicine, Eulji University Hospital, 1306, Dunsan 2-dong, Seo-gu, Daejeon, Republic of Korea
h Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1, Pungnap 2-dong, Songpa-gu, Seoul, Republic of Korea
http://dx.doi.org/10.1016/j.vaccine.2013.02.066
Highlights
?
We evaluated the effectiveness of the A(H1N1)pdm09 vaccine in hospital workers.
?
Crude vaccine effectiveness (VE) was 81.8%.
?
Adjusted VE was 81.9%.
?
The vaccine effectively protected the hospital workers against the A(H1N1)pdm09
?
VE estimates were sensitive to varying adjustment or assumptions (75.4?93.3%).
Abstract
The A(H1N1)pdm09 vaccine was developed and administered to hospital workers at first during the peak of the outbreak in Korea. The present multicenter cohort study was conducted to evaluate whether the A(H1N1)pdm09 vaccine effectively protected hospital workers. The study vaccine contained 15 ?g of A/California/7/2009 NYMC X-179A(H1N1) without adjuvant, Greenflu-S?. Participants were requested in December 2009 and April 2010 to answer a questionnaire about whether they had been confirmed to be A(H1N1)pdm09 patients based on the real-time reverse transcription-polymerase chain reaction (RT-PCR) assay and had received the A(H1N1)pdm09 vaccine. The vaccination and incidence rates of the A(H1N1)pdm09 were 96.4% (8769/9097), and 0.6% (57/9097), respectively. The crude vaccine effectiveness (VE) was calculated to be 81.8% [95% confidence interval (CI); 61.0?91.5%], while the effectiveness adjusted for hospital, immunization with seasonal trivalent influenza vaccine (TIV) in 2009?10, contact with A(H1N1)pdm09 patients, pre-existing disease, smoking history, and date of follow-up start was 81.9% (95% CI; 52.8?93.1%). When we defined insufficiently immunized cases as unvaccinated, instead of deleting them from the cohort, the adjusted VE increased up to 93.3%. In conclusion, the unadjuvanted monovalent A(H1N1)pdm vaccine was highly protective in hospital workers against laboratory-confirmed A(H1N1)pdm09 infections. VE estimates were sensitive to varying adjustment or assumptions (75.4?93.3%), which suggest the necessity of careful analysis of VE.
http://www.sciencedirect.com/science/article/pii/S0264410X13002557
Available online 13 March 2013
In Press, Uncorrected Proof ? Note to users
Cover image
Evaluation and sensitivity analysis of the effectiveness of unadjuvanted A(H1N1)pdm09 vaccine in hospital workers using multi-center cohort study in Korea
J. Lima,
B. Choib,
J. Kimc,
J. Kimd,
C. Kime,
J. Parkf,
H. Yoong,
S. Hongh,
J. Seob,
M. Kia, Corresponding author contact information, E-mail the corresponding author
a Department of Preventive Medicine, Eulji University School of Medicine, 143-5, Yongdu-dong, Jung-gu, Daejeon, Republic of Korea
b Department of Preventive Medicine, Hanyang University Medical School, 222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea
c Department of Pediatrics, Chonbuk National University Medical School, 567, Baekjedae-ro, Deokjin-gu, Jeonju, Jeonbuk, Republic of Korea
d Department of Laboratory Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, 38, Bangtong-gil, Sacheon-myeon, Gangneug, Gangwon-do, Republic of Korea
e Department of Pediatrics, Soonchunhyang University Bucheon Hospital, 170, Jomaru-ro, Wonmi-gu, Bucheon, Gyeonggi-do, Republic of Korea
f Department of Pediatrics, Soonchunhyang University Hospital, 31, Soonchunhyang 6-gil, Dongnam-gu, Cheonan, Chungcheongnam-do, Republic of Korea
g Division of Infectious diseases, Department of Internal Medicine, Eulji University Hospital, 1306, Dunsan 2-dong, Seo-gu, Daejeon, Republic of Korea
h Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1, Pungnap 2-dong, Songpa-gu, Seoul, Republic of Korea
http://dx.doi.org/10.1016/j.vaccine.2013.02.066
Highlights
?
We evaluated the effectiveness of the A(H1N1)pdm09 vaccine in hospital workers.
?
Crude vaccine effectiveness (VE) was 81.8%.
?
Adjusted VE was 81.9%.
?
The vaccine effectively protected the hospital workers against the A(H1N1)pdm09
?
VE estimates were sensitive to varying adjustment or assumptions (75.4?93.3%).
Abstract
The A(H1N1)pdm09 vaccine was developed and administered to hospital workers at first during the peak of the outbreak in Korea. The present multicenter cohort study was conducted to evaluate whether the A(H1N1)pdm09 vaccine effectively protected hospital workers. The study vaccine contained 15 ?g of A/California/7/2009 NYMC X-179A(H1N1) without adjuvant, Greenflu-S?. Participants were requested in December 2009 and April 2010 to answer a questionnaire about whether they had been confirmed to be A(H1N1)pdm09 patients based on the real-time reverse transcription-polymerase chain reaction (RT-PCR) assay and had received the A(H1N1)pdm09 vaccine. The vaccination and incidence rates of the A(H1N1)pdm09 were 96.4% (8769/9097), and 0.6% (57/9097), respectively. The crude vaccine effectiveness (VE) was calculated to be 81.8% [95% confidence interval (CI); 61.0?91.5%], while the effectiveness adjusted for hospital, immunization with seasonal trivalent influenza vaccine (TIV) in 2009?10, contact with A(H1N1)pdm09 patients, pre-existing disease, smoking history, and date of follow-up start was 81.9% (95% CI; 52.8?93.1%). When we defined insufficiently immunized cases as unvaccinated, instead of deleting them from the cohort, the adjusted VE increased up to 93.3%. In conclusion, the unadjuvanted monovalent A(H1N1)pdm vaccine was highly protective in hospital workers against laboratory-confirmed A(H1N1)pdm09 infections. VE estimates were sensitive to varying adjustment or assumptions (75.4?93.3%), which suggest the necessity of careful analysis of VE.
http://www.sciencedirect.com/science/article/pii/S0264410X13002557