PMID- 29767739
OWN - NLM
STAT- MEDLINE
DCOM- 20190912
LR  - 20190912
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 218
IP  - 1
DP  - 2018 Jun 5
TI  - Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: 
      Subgroup Analysis of Participants From Asian Countries.
PG  - 95-108
LID - 10.1093/infdis/jiy133 [doi]
AB  - BACKGROUND: A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) 
      vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) 
      in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, 
      immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, 
      Japan, Taiwan, and Thailand) from 2 international studies: a randomized, 
      double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 
      years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 
      9-15 years; NCT00943722; Study 002). METHODS: Participants (N = 2519) were 
      vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) 
      and serum were collected for HPV DNA and antibody assessments, respectively. 
      Injection-site and systemic adverse events (AEs) were monitored. Data were 
      analyzed by country and vaccination group. RESULTS: 9vHPV vaccine prevented 
      HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across 
      included countries. At month 7, >/=97.9% of participants seroconverted for each HPV 
      type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 
      9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of 
      girls/boys in Study 002; most were mild to moderate. CONCLUSIONS: The 9vHPV 
      vaccine is efficacious, immunogenic, and well tolerated in Asian participants. 
      Data support 9vHPV vaccination programs in Asia. CLINICAL TRIALS REGISTRATION: 
      NCT00543543; NCT00943722.
FAU - Garland, S M
AU  - Garland SM
AD  - Western Pacific Regional HPV Labnet Reference Laboratory, Department of 
      Infectious Disease and Microbiology, Royal Women's Hospital, Murdoch Children's 
      Research Institute, Royal Children's Hospital and Department of Obstetrics and 
      Gynaecology, University of Melbourne, Parkville, Victoria, Australia.
FAU - Pitisuttithum, P
AU  - Pitisuttithum P
AD  - Vaccine Trial Centre, Mahidol University, Salaya, Thailand.
FAU - Ngan, H Y S
AU  - Ngan HYS
AD  - Department of Obstetrics and Gynaecology, the University of Hong Kong, China.
FAU - Cho, C-H
AU  - Cho CH
AD  - Department of Obstetrics and Gynecology, Keimyung University School of Medicine, 
      Daegu, South Korea.
FAU - Lee, C-Y
AU  - Lee CY
AD  - Department of Gynecology, Chang Gung Memorial Hospital, Chiayi Branch, Taipei.
FAU - Chen, C-A
AU  - Chen CA
AD  - Department of Obstetrics and Gynecology, National Taiwan University Hospital, 
      Taipei.
FAU - Yang, Y C
AU  - Yang YC
AD  - MacKay Memorial Hospital, Taipei.
FAU - Chu, T-Y
AU  - Chu TY
AD  - Tzu Chi Medical Center, Hualien.
FAU - Twu, N-F
AU  - Twu NF
AD  - Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, 
      Taipei, Taiwan.
FAU - Samakoses, R
AU  - Samakoses R
AD  - Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
FAU - Takeuchi, Y
AU  - Takeuchi Y
AD  - Fukui General Hospital, Japan.
FAU - Cheung, T H
AU  - Cheung TH
AD  - Department of Obstetric and Gynaecology, Chinese University of Hong Kong, China.
FAU - Kim, S C
AU  - Kim SC
AD  - Division of Gynecologic Oncology, Ewha Womans University Mokdong Hospital, School 
      of Medicine Ewha Womans University, Seoul, South Korea.
FAU - Huang, L-M
AU  - Huang LM
AD  - Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Kim, B-G
AU  - Kim BG
AD  - Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan 
      University School of Medicine, Seoul, South Korea.
FAU - Kim, Y-T
AU  - Kim YT
AD  - Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, 
      Asian Medical Center, Seoul, South Korea.
FAU - Kim, K-H
AU  - Kim KH
AD  - Department of Pediatrics and Center for Vaccine Evaluation and Study, Ewha Womans 
      University College of Medicine, Seoul, South Korea.
FAU - Song, Y-S
AU  - Song YS
AD  - Obstetrics and Gynecology, College of Medicine, Seoul National University, Seoul, 
      South Korea.
FAU - Lalwani, S
AU  - Lalwani S
AD  - Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India.
FAU - Kang, J-H
AU  - Kang JH
AD  - Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, the 
      Catholic University of Korea, South Korea.
FAU - Sakamoto, M
AU  - Sakamoto M
AD  - Department of Gynaecology, Sasaki Foundation Kyoundo Hospital and Department of 
      Obstetrics and Gynaecology, School of Medicine, the Jikei University, Tokyo, 
      Japan.
FAU - Ryu, H-S
AU  - Ryu HS
AD  - Department of Obstetrics and Gynecology, School of Medicine, Ajou University, 
      Suwon, South Korea.
FAU - Bhatla, N
AU  - Bhatla N
AD  - Department of Obstetrics and Gynaecology, All India Institute of Medical 
      Sciences, New Delhi, India.
FAU - Yoshikawa, H
AU  - Yoshikawa H
AD  - Ibaraki Prefectural Central Hospital, Kasama, Ibaraki, Japan.
FAU - Ellison, M C
AU  - Ellison MC
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Han, S R
AU  - Han SR
AD  - MSD K.K., Tokyo, Japan.
FAU - Moeller, E
AU  - Moeller E
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Murata, S
AU  - Murata S
AD  - MSD K.K., Tokyo, Japan.
FAU - Ritter, M
AU  - Ritter M
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Sawata, M
AU  - Sawata M
AD  - MSD K.K., Tokyo, Japan.
FAU - Shields, C
AU  - Shields C
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Walia, A
AU  - Walia A
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Perez, G
AU  - Perez G
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Luxembourg, A
AU  - Luxembourg A
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT00543543
SI  - ClinicalTrials.gov/NCT00943722
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antibodies, Viral)
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral/blood
MH  - Asia/epidemiology
MH  - Child
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Genitalia, Female/virology
MH  - Humans
MH  - Male
MH  - Papillomaviridae/*classification/genetics/*isolation & purification
MH  - Papillomavirus Infections/epidemiology/*prevention & control/*virology
MH  - Papillomavirus Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5989602
EDAT- 2018/05/17 06:00
MHDA- 2019/09/13 06:00
PMCR- 2018/05/15
CRDT- 2018/05/17 06:00
PHST- 2017/11/15 00:00 [received]
PHST- 2018/03/16 00:00 [accepted]
PHST- 2018/05/17 06:00 [pubmed]
PHST- 2019/09/13 06:00 [medline]
PHST- 2018/05/17 06:00 [entrez]
PHST- 2018/05/15 00:00 [pmc-release]
AID - 4996119 [pii]
AID - jiy133 [pii]
AID - 10.1093/infdis/jiy133 [doi]
PST - ppublish
SO  - J Infect Dis. 2018 Jun 5;218(1):95-108. doi: 10.1093/infdis/jiy133.