A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) - Study protocol for a randomised controlled trial.
Growth performance
Microbiota
Olive flounder
Probiotic
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
10
09
2020
revised:
20
12
2020
accepted:
03
01
2021
pubmed:
10
1
2021
medline:
25
9
2021
entrez:
9
1
2021
Statut:
ppublish
Résumé
Human papillomavirus (HPV) infection is the primary cause of cervical cancer. In 2018, the World Health Organization (WHO) Director General announced his commitment to eliminate cervical cancer, with HPV vaccination as a priority. However, the costs of setting up a multi-dose HPV vaccination programme remain a barrier to its introduction. We are conducting a randomised-controlled trial of reduced dose schedules of HPV vaccine in Tanzania to establish whether a single dose produces immune responses that will be effective in preventing cervical cancer. 930 girls aged 9-14 years in Mwanza, Tanzania, were randomised to one of 6 arms, comprising 3 different dose schedules of the 2-valent (Cervarix) and 9-valent (Gardasil-9) HPV vaccines: 3 doses; 2 doses given 6 months apart; or a single dose. All participants will be followed for 36 months; those in the 1 and 2 dose arms will be followed for 60 months. Trial outcomes focus on vaccine immune responses including HPV 16/18-specific antibody levels, antibody avidity, and memory B cell responses. Results will be immunobridged to historical cohorts of girls and young women in whom efficacy has been demonstrated. This is the first randomised trial of the single dose HPV vaccine schedule in the target age group. The trial will allow us to examine the quality and durability of immune responses of reduced dose schedules in a population with high burden of malaria and other infections that may affect vaccine immune responses. Initial results (24 months) are expected to be published in early 2021.
Sections du résumé
BACKGROUND
Human papillomavirus (HPV) infection is the primary cause of cervical cancer. In 2018, the World Health Organization (WHO) Director General announced his commitment to eliminate cervical cancer, with HPV vaccination as a priority. However, the costs of setting up a multi-dose HPV vaccination programme remain a barrier to its introduction.
METHODS/DESIGN
We are conducting a randomised-controlled trial of reduced dose schedules of HPV vaccine in Tanzania to establish whether a single dose produces immune responses that will be effective in preventing cervical cancer. 930 girls aged 9-14 years in Mwanza, Tanzania, were randomised to one of 6 arms, comprising 3 different dose schedules of the 2-valent (Cervarix) and 9-valent (Gardasil-9) HPV vaccines: 3 doses; 2 doses given 6 months apart; or a single dose. All participants will be followed for 36 months; those in the 1 and 2 dose arms will be followed for 60 months. Trial outcomes focus on vaccine immune responses including HPV 16/18-specific antibody levels, antibody avidity, and memory B cell responses. Results will be immunobridged to historical cohorts of girls and young women in whom efficacy has been demonstrated.
DISCUSSION
This is the first randomised trial of the single dose HPV vaccine schedule in the target age group. The trial will allow us to examine the quality and durability of immune responses of reduced dose schedules in a population with high burden of malaria and other infections that may affect vaccine immune responses. Initial results (24 months) are expected to be published in early 2021.
Identifiants
pubmed: 33421649
pii: S1551-7144(21)00002-1
doi: 10.1016/j.cct.2021.106266
pmc: PMC7970022
pii:
doi:
Substances chimiques
Papillomavirus Vaccines
0
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106266Subventions
Organisme : NCI NIH HHS
ID : HHSN261200800001E
Pays : United States
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N006135/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : G0901756
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/R010161/1
Pays : United Kingdom
Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
Références
Vaccine. 2006 Aug 31;24 Suppl 3:S3/233-41
pubmed: 16950012
BMC Med. 2012 Nov 13;10:137
pubmed: 23148516
J Clin Virol. 2013 Apr;56(4):336-41
pubmed: 23290386
Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791
pubmed: 29551226
Stat Med. 1990 Dec;9(12):1447-54
pubmed: 2281232
Hum Vaccin Immunother. 2014;10(12):3435-45
pubmed: 25483701
Bull World Health Organ. 2013 Aug 1;91(8):585-92
pubmed: 23940406
Contemp Clin Trials. 2021 Jan;100:106225
pubmed: 33227451
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593
Chem Immunol. 2002;80:229-42
pubmed: 12058641
Nat Rev Clin Oncol. 2016 Feb;13(2):119-32
pubmed: 26323382
JAMA. 2006 Mar 8;295(10):1152-60
pubmed: 16522836
Mol Cell Probes. 2012 Apr;26(2):73-80
pubmed: 22285687
J Natl Cancer Inst. 2020 Oct 1;112(10):1038-1046
pubmed: 32091594
J Infect Dis. 2018 Jul 2;218(3):398-405
pubmed: 29529245
Gynecol Oncol. 2017 Jul;146(1):196-204
pubmed: 28442134
Sex Transm Infect. 2020 May;96(3):211-219
pubmed: 31221744
J Adolesc Health. 2016 Mar;58(3):295-301
pubmed: 26725717
Vaccine. 2016 Mar 18;34(13):1559-1565
pubmed: 26896686
Sex Transm Infect. 2013 Aug;89(5):358-65
pubmed: 23486859
Wkly Epidemiol Rec. 2014 May 23;89(21):221-36
pubmed: 24864348
Hum Vaccin. 2011 Dec;7(12):1374-86
pubmed: 22048171
Cancer Discov. 2011 Oct;1(5):408-19
pubmed: 22586631
Vaccine. 2014 Jan 23;32(5):611-7
pubmed: 24291193
Lancet Oncol. 2015 Jul;16(7):775-86
pubmed: 26071347
Vaccine. 2008 Jul 4;26(29-30):3608-16
pubmed: 18541349
Hum Vaccin. 2011 Dec;7(12):1343-58
pubmed: 22048173
JAMA. 2013 May 1;309(17):1793-802
pubmed: 23632723