TY - JOUR
T1 - Effectiveness of the quadrivalent inactivated influenza vaccine in Japan during the 2015–2016 season
T2 - A test-negative case-control study comparing the results by real time PCR, virus isolation
AU - Chon, Irina
AU - Saito, Reiko
AU - Hibino, Akinobu
AU - Yagami, Ren
AU - Dapat, Clyde
AU - Odagiri, Takashi
AU - Kondo, Hiroki
AU - Sato, Isamu
AU - Kimura, Shinji
AU - Kawashima, Takashi
AU - Kodo, Naoki
AU - Masaki, Hironori
AU - Asoh, Norichika
AU - Tsuchihashi, Yoshiko
AU - Zaraket, Hassan
AU - Shobugawa, Yugo
N1 - Funding Information:
This work was supported by JSPS Core-to-core Program, B.Asia-Africa Science Platforms, and Kakenhi (Grants-in-Aid for Scientific Research), sourced from the Ministry of Education, Culture, Sports, Science and Technology (MEXT), and Health and Labor Sciences Research Grant, Ministry of Health, Labor and Welfare, Japan . It was partially supported by the Japan Initiative for Global Research Network on Infectious Diseases (J-GRID) from MEXT and Japan Agency for Medical Research and Development (AMED). One of the RDT products used in this study (Quick-Navi Flu + RSV) was donated by Denka Seiken CO., Ltd (Tokyo, Japan).
Publisher Copyright:
© 2019 The Author(s)
PY - 2019/4/11
Y1 - 2019/4/11
N2 - Background: We estimated influenza vaccine effectiveness (VE) in 2015–2016 season against medically attended, laboratory-confirmed influenza, when quadrivalent inactivated vaccine (IIV4) was first introduced in Japan, using test-negative case-control design. Influenza A(H1N1)pdm09 cocirculated with B/Yamagata and B/Victoria during the study period in Japan. Method: We based our case definition on two laboratory tests, real-time reverse transcription polymerase chain reaction (RT PCR), and virus isolation and compared VEs based on these tests. In addition, VE was evaluated by rapid diagnostic test (RDT). Nasopharyngeal swabs were collected from outpatients who visited clinics with influenza-like illness (ILIs) in Hokkaido, Niigata, Gunma and Nagasaki prefectures. Results: Among 713 children and adults enrolled in this study, 578 were influenza positive by RT PCR including, 392 influenza A and 186 influenza B, while 135 were tested negative controls. The adjusted VE by RT PCR for all ages against any influenza was low protection of 36.0% (95% confidence interval [CI], 3.1% to 58.6%), for influenza A was 30.0% (95% CI: −10.0% to 55.5%), and influenza B was moderate 50.2% (95% CI: 13.3% to 71.4%). Adjusted VE for virus isolation for A(H1N1)pdm09 was 37.1% (95% CI: 1.7% to 59.7%), Yamagata lineage 51.3% (95% CI: 6.4% to 74.7%) and Victoria lineage 21.3% (95% CI: −50.0% to 58.9%). VE was highest and protective in 0–5 years old group against any influenza and influenza A and B/Yamagata, but the protective effect was not observed for other age groups and B/Victoria. RDT demonstrated concordant results with RT PCR and virus isolation. Sequencing of hemagglutinin gene showed that all A(H1N1)pdm09 belong to clade 6B including 31 strains (88.6%), which belong to clade 6B.1 possessing S162N mutations that may alter antigenicity and affect VE for A(H1N1)pdm09. Conclusions: IIV4 influenza vaccine during 2015–2016 was effective against A(H1N1)pdm09 and the two lineages of type B. Younger children was more protected than older children and adults by vaccination.
AB - Background: We estimated influenza vaccine effectiveness (VE) in 2015–2016 season against medically attended, laboratory-confirmed influenza, when quadrivalent inactivated vaccine (IIV4) was first introduced in Japan, using test-negative case-control design. Influenza A(H1N1)pdm09 cocirculated with B/Yamagata and B/Victoria during the study period in Japan. Method: We based our case definition on two laboratory tests, real-time reverse transcription polymerase chain reaction (RT PCR), and virus isolation and compared VEs based on these tests. In addition, VE was evaluated by rapid diagnostic test (RDT). Nasopharyngeal swabs were collected from outpatients who visited clinics with influenza-like illness (ILIs) in Hokkaido, Niigata, Gunma and Nagasaki prefectures. Results: Among 713 children and adults enrolled in this study, 578 were influenza positive by RT PCR including, 392 influenza A and 186 influenza B, while 135 were tested negative controls. The adjusted VE by RT PCR for all ages against any influenza was low protection of 36.0% (95% confidence interval [CI], 3.1% to 58.6%), for influenza A was 30.0% (95% CI: −10.0% to 55.5%), and influenza B was moderate 50.2% (95% CI: 13.3% to 71.4%). Adjusted VE for virus isolation for A(H1N1)pdm09 was 37.1% (95% CI: 1.7% to 59.7%), Yamagata lineage 51.3% (95% CI: 6.4% to 74.7%) and Victoria lineage 21.3% (95% CI: −50.0% to 58.9%). VE was highest and protective in 0–5 years old group against any influenza and influenza A and B/Yamagata, but the protective effect was not observed for other age groups and B/Victoria. RDT demonstrated concordant results with RT PCR and virus isolation. Sequencing of hemagglutinin gene showed that all A(H1N1)pdm09 belong to clade 6B including 31 strains (88.6%), which belong to clade 6B.1 possessing S162N mutations that may alter antigenicity and affect VE for A(H1N1)pdm09. Conclusions: IIV4 influenza vaccine during 2015–2016 was effective against A(H1N1)pdm09 and the two lineages of type B. Younger children was more protected than older children and adults by vaccination.
KW - Influenza
KW - Influenza vaccine
KW - Japan
KW - Quadrivalent inactivated vaccine (IIV4)
KW - Test negative case-control design
KW - Vaccine effectiveness
UR - http://www.scopus.com/inward/record.url?scp=85061289970&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061289970&partnerID=8YFLogxK
U2 - 10.1016/j.jvacx.2019.100011
DO - 10.1016/j.jvacx.2019.100011
M3 - Article
AN - SCOPUS:85061289970
VL - 1
JO - Vaccine: X
JF - Vaccine: X
SN - 2590-1362
M1 - 100011
ER -
