PMID- 34678491
OWN - NLM
STAT- MEDLINE
DCOM- 20220419
LR  - 20220512
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Linking)
VI  - 115
DP  - 2022 Apr
TI  - Design of a phase III efficacy, immunogenicity, and safety study of 9-valent 
      human papillomavirus vaccine in prevention of oral persistent infection in men.
PG  - 106592
LID - S1551-7144(21)00328-1 [pii]
LID - 10.1016/j.cct.2021.106592 [doi]
AB  - BACKGROUND: Seven high-risk human papillomavirus (HPV) types 
      (16/18/31/33/45/52/58) covered by the 9-valent HPV (9vHPV) vaccine cause >90% of 
      HPV-related head and neck cancers (HNCs). An ongoing clinical trial (NCT04199689) 
      was designed to evaluate 9vHPV vaccine efficacy against HPV oral persistent 
      infection, a surrogate endpoint for HPV-related HNCs. METHODS: In this 
      double-blind, placebo-controlled, international trial, men aged 20-45 years 
      (N = 6000) are randomized 1:1 to receive 9vHPV vaccine or placebo on day 1, month 
      2, and month 6. The primary objective is to demonstrate whether 9vHPV vaccination 
      reduces incidence of HPV16/18/31/33/45/52/58-related 6-month oral persistent 
      infection. Incidence of HPV6/11-related 6-month oral persistent infection will be 
      evaluated as a secondary endpoint. Oral rinse and gargle samples will be 
      collected on day 1, month 7, month 12, and every 6 months thereafter for HPV 
      detection by PCR. Primary analyses will be performed in per-protocol populations. 
      Efficacy in this case-driven study will be analyzed upon accrual of >/=20 primary 
      efficacy endpoint cases. Serum will be collected at day 1 and months 7, 12, 24, 
      36, and 42; anti-HPV antibody titers will be measured by competitive Luminex 
      immunoassay. Data will be summarized as geometric mean titers and seropositivity 
      rates. Injection-site and systemic adverse events (AEs) will be collected for 
      15 days post-any vaccination and serious AEs through 6 months after the last 
      vaccination; deaths and vaccine-related serious AEs will be collected throughout 
      the study. DISCUSSION: This trial is expected to generate important data 
      regarding the potential for 9vHPV vaccine to prevent HPV-related head and neck 
      disease.
CI  - Copyright (c) 2022 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 
      Kenilworth, NJ USA, The Author(s). Published by Elsevier Inc. All rights 
      reserved.
FAU - Giuliano, Anna R
AU  - Giuliano AR
AD  - Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center 
      and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, USA.
FAU - Wilkin, Timothy
AU  - Wilkin T
AD  - Weill Cornell Medicine, 53 W. 23(rd) St., New York, NY 10010, USA.
FAU - Bautista, Oliver M
AU  - Bautista OM
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Cheon, Kyeongmi
AU  - Cheon K
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Connor, Laurie
AU  - Connor L
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Dubey, Sheri
AU  - Dubey S
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
CN  - Thomas Group
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Luxembourg, Alain
AU  - Luxembourg A
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Rawat, Sonali
AU  - Rawat S
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Shaw, Anita
AU  - Shaw A
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Velicer, Christine
AU  - Velicer C
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Vendetti, Neika
AU  - Vendetti N
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA.
FAU - Tu, Yingmei
AU  - Tu Y
AD  - Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic 
      address: ying.mei.tu@merck.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT04199689
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211019
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
RN  - 0 (Antibodies, Viral)
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Antibodies, Viral
MH  - Double-Blind Method
MH  - Human papillomavirus 16
MH  - Human papillomavirus 18
MH  - Humans
MH  - Male
MH  - Papillomaviridae
MH  - *Papillomavirus Infections/prevention & control
MH  - *Papillomavirus Vaccines
MH  - Persistent Infection
OTO - NOTNLM
OT  - 9-valent human papillomavirus vaccine
OT  - Efficacy
OT  - Head and neck cancer
OT  - Immunogenicity
OT  - Oral human papillomavirus infection
OT  - Safety
EDAT- 2021/10/23 06:00
MHDA- 2022/04/20 06:00
CRDT- 2021/10/22 20:34
PHST- 2021/06/24 00:00 [received]
PHST- 2021/09/01 00:00 [revised]
PHST- 2021/10/05 00:00 [accepted]
PHST- 2021/10/23 06:00 [pubmed]
PHST- 2022/04/20 06:00 [medline]
PHST- 2021/10/22 20:34 [entrez]
AID - S1551-7144(21)00328-1 [pii]
AID - 10.1016/j.cct.2021.106592 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2022 Apr;115:106592. doi: 10.1016/j.cct.2021.106592. Epub 
      2021 Oct 19.