PMID- 33844623
OWN - NLM
STAT- MEDLINE
DCOM- 20210705
LR  - 20221207
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 7
DP  - 2021 Jul 3
TI  - Immunogenicity and safety of a nine-valent human papillomavirus vaccine in 
      Vietnamese males and females (9 to 26 years of age): an open-label, phase 3 
      trial.
PG  - 1980-1985
LID - 10.1080/21645515.2020.1865739 [doi]
AB  - This open-label, single-center, Phase 3 study (NCT03546842) assessed the 
      immunogenicity and safety of the nine-valent human papillomavirus (9vHPV; 
      HPV6/11/16/18/31/33/45/52/58) vaccine in Vietnamese males and females, with the 
      aim to support 9vHPV vaccine licensure in Vietnam. Participants aged 9-26 years 
      received three 9vHPV vaccine doses (Day 1, Month 2, Month 6). Serum samples were 
      obtained on Day 1 (pre-vaccination) and at Month 7 (one month post-Dose 3) for 
      the measurement of anti-HPV antibodies. Geometric mean titers (GMTs) and 
      seroconversion percentages were obtained using the HPV-9 competitive Luminex 
      immunoassay. Injection-site adverse events (AEs), systemic AEs, serious AEs 
      (SAEs), and study discontinuations due to AEs were recorded. Of 201 participants 
      enrolled, 200 (99.5%) received >/=1 vaccine dose. All participants who received the 
      three-dose regimen (198/200, 98.5%) seroconverted for all 9vHPV vaccine types by 
      Month 7. Robust anti-HPV GMT responses were also observed. Half of participants 
      (50.5%) reported >/=1 AE; the majority were injection-site-related (45.0%) and mild 
      (43.0%). There were no deaths, vaccine-related SAEs, or discontinuations due to 
      AEs. Administration of three 9vHPV vaccine doses was highly immunogenic and 
      resulted in acceptable seropositivity percentages for all vaccine HPV types. The 
      9vHPV vaccine was generally well tolerated among this study population.Region of 
      origin: VietnamTrial registration: clinicaltrials.gov Identifier NCT03546842.
FAU - Thiem, Vu Dinh
AU  - Thiem VD
AUID- ORCID: 0000-0001-6168-4555
AD  - National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
FAU - Quang, Nguyen Dang
AU  - Quang ND
AUID- ORCID: 0000-0002-4208-8878
AD  - National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
FAU - Tuan, Nguyen Hai
AU  - Tuan NH
AUID- ORCID: 0000-0003-3791-5215
AD  - National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
FAU - Cheon, Kyeongmi
AU  - Cheon K
AUID- ORCID: 0000-0003-1357-0371
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Gallagher, Nancy
AU  - Gallagher N
AUID- ORCID: 0000-0002-5860-219X
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Luxembourg, Alain
AU  - Luxembourg A
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Group, Thomas
AU  - Group T
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Badshah, Cyrus
AU  - Badshah C
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03546842
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210412
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral
MH  - Asian People
MH  - Child
MH  - Female
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Male
MH  - Papillomaviridae
MH  - *Papillomavirus Infections/prevention & control
MH  - *Papillomavirus Vaccines/adverse effects
MH  - Vietnam/epidemiology
MH  - Young Adult
PMC - PMC8189095
OTO - NOTNLM
OT  - Human papillomavirus (HPV)
OT  - Vietnam
OT  - immunogenicity
OT  - nine-valent human papillomavirus vaccine
OT  - safety
EDAT- 2021/04/13 06:00
MHDA- 2021/07/06 06:00
PMCR- 2021/04/12
CRDT- 2021/04/12 17:13
PHST- 2021/04/13 06:00 [pubmed]
PHST- 2021/07/06 06:00 [medline]
PHST- 2021/04/12 17:13 [entrez]
PHST- 2021/04/12 00:00 [pmc-release]
AID - 1865739 [pii]
AID - 10.1080/21645515.2020.1865739 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 Jul 3;17(7):1980-1985. doi: 
      10.1080/21645515.2020.1865739. Epub 2021 Apr 12.