PMID- 35352698
OWN - NLM
STAT- MEDLINE
DCOM- 20220930
LR  - 20221004
IS  - 1473-5709 (Electronic)
IS  - 0959-8278 (Linking)
VI  - 31
IP  - 6
DP  - 2022 Nov 1
TI  - Immunogenicity and safety of a bivalent, adjuvant system 04-adjuvanted human 
      papillomavirus vaccine in healthy female volunteers aged 15-25: a randomized, 
      double-blind, phase III, noninferiority clinical trial.
PG  - 558-567
LID - 10.1097/CEJ.0000000000000753 [doi]
AB  - OBJECTIVE: Vaccination is proven to significantly reduce the risk of human 
      papillomavirus (HPV)-related complications, especially cervical cancer. This 
      study aimed to assess the immunogenicity and safety of the investigational 
      bivalent HPV vaccine (16/18), named Papilloguard (Noyan Pajouhan Biopharma, 
      Tehran, Iran), in comparison with the reference product (Cervarix, bivalent HPV 
      vaccine (16/18) manufactured by GlaxoSmithKline, Rixensart, Belgium) in a 
      three-dose regimen. METHODS: This trial was a randomized, controlled, 
      double-blind, phase III study of two HPV vaccines in healthy female volunteers 
      aged 15-25. The primary endpoint was to test the noninferiority of Papilloguard 
      (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) as measured by the 
      geometric mean titer (GMT) ratios of HPV-16 and HPV-18 7 months after the first 
      vaccination. Secondary endpoints were the proportion of local and systemic 
      solicited and unsolicited events, and the number of females with seroconversion 
      against HPV-16 and HPV-18 7 months after the first vaccination. RESULTS: Out of 
      504 screened women, 218 were enrolled. Seven months after the first vaccination, 
      GMT ratios of HPV-16 and HPV-18 were 0.59 and 0.93, respectively. The 
      seroconversion rates of both Papilloguard (Noyan Pajouhan Biopharma) and Cervarix 
      (GlaxoSmithKline) were more than 96%. Both vaccinated groups had a generally good 
      profile of solicited and unsolicited adverse events (AEs). The most common AE was 
      discomfort at the injection site, which was well tolerated. CONCLUSION: The 
      result analysis of this study supports the noninferiority of Papilloguard (Noyan 
      Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) in terms of safety and 
      immunogenicity based on the GMT ratio. However, long-term comparative studies to 
      evaluate the sustainability of GMT response and risk of cervical intraepithelial 
      neoplasia grades 2-3 are needed.
CI  - Copyright (c) 2022 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Afshani, Seyyedeh Maryam
AU  - Afshani SM
AD  - Faculty of Pharmacy, Tehran University of Medical Sciences.
AD  - Medical Department, Arta Pharmed Company.
FAU - Mirhassani, Reihaneh
AU  - Mirhassani R
AD  - Department of Biotechnology, College of Science, University of Tehran.
AD  - Noyan Pajouhan Biopharma, Biotechnology Research Center.
FAU - Hosseini, Hamed
AU  - Hosseini H
AD  - Clinical Trial Center, Tehran University of Medical Sciences.
FAU - Hosseini, Reihaneh
AU  - Hosseini R
AD  - Department of Gynecology and Obstetrics, Arash Women's Hospital, Tehran 
      University of Medical Science.
FAU - Tehranian, Afsaneh
AU  - Tehranian A
AD  - Department of Gynecology and Obstetrics, Arash Women's Hospital, Tehran 
      University of Medical Science.
FAU - Malekzadeh, Reza
AU  - Malekzadeh R
AD  - Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research 
      Institute, Tehran University of Medical Sciences.
FAU - Ostovar, Afshin
AU  - Ostovar A
AD  - Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences 
      Institute, Tehran University of Medical Sciences.
FAU - Abdolghaffari, Amir Hossein
AU  - Abdolghaffari AH
AD  - Noyan Pajouhan Biopharma, Biotechnology Research Center.
AD  - Department of Toxicology & Pharmacology, Faculty of Pharmacy, Tehran Medical 
      Sciences, Islamic Azad University.
AD  - Gastrointestinal Pharmacology Interest Group (GPIG), Universal Scientific 
      Education and Research Network (USERN), Tehran, Iran.
FAU - Ghobadi, Mohammad Amin
AU  - Ghobadi MA
AD  - Faculty of Pharmacy, Tehran University of Medical Sciences.
AD  - Medical Department, Arta Pharmed Company.
FAU - Hedayatjoo, Behnaz
AU  - Hedayatjoo B
AD  - Medical Department, Arta Pharmed Company.
FAU - Hazegh Fetratjoo, Delara
AU  - Hazegh Fetratjoo D
AD  - Faculty of Pharmacy, Tehran University of Medical Sciences.
AD  - Medical Department, Arta Pharmed Company.
FAU - Rezagholi, Zahra
AU  - Rezagholi Z
AD  - Faculty of Pharmacy, Tehran University of Medical Sciences.
AD  - Medical Department, Arta Pharmed Company.
FAU - Anari, AmirHossein
AU  - Anari A
AD  - Faculty of Pharmacy, Tehran University of Medical Sciences.
AD  - Medical Department, Arta Pharmed Company.
FAU - Moini, Ashraf
AU  - Moini A
AD  - Department of Gynecology and Obstetrics, Arash Women's Hospital, Tehran 
      University of Medical Science.
LA  - eng
SI  - IRCT/IRCT20090526001952N9
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220329
PL  - England
TA  - Eur J Cancer Prev
JT  - European journal of cancer prevention : the official journal of the European 
      Cancer Prevention Organisation (ECP)
JID - 9300837
RN  - 0 (ASO4 mixture)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Lipid A)
RN  - 0 (Papillomavirus Vaccines)
RN  - 5QB0T2IUN0 (Aluminum Hydroxide)
SB  - IM
MH  - Aluminum Hydroxide
MH  - Antibodies, Viral
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Iran/epidemiology
MH  - Lipid A/analogs & derivatives
MH  - Papillomaviridae
MH  - *Papillomavirus Infections/prevention & control
MH  - *Papillomavirus Vaccines/adverse effects
EDAT- 2022/03/31 06:00
MHDA- 2022/10/01 06:00
CRDT- 2022/03/30 08:40
PHST- 2022/03/31 06:00 [pubmed]
PHST- 2022/10/01 06:00 [medline]
PHST- 2022/03/30 08:40 [entrez]
AID - 00008469-202211000-00010 [pii]
AID - 10.1097/CEJ.0000000000000753 [doi]
PST - ppublish
SO  - Eur J Cancer Prev. 2022 Nov 1;31(6):558-567. doi: 10.1097/CEJ.0000000000000753. 
      Epub 2022 Mar 29.