Trial Title:
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
NCT ID:
NCT05495906
Condition:
HPV
Human Papilloma Virus
Human Immunodeficiency Virus
Conditions: Official terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Papilloma
Conditions: Keywords:
HPV vaccination
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Nonavalent HPV vaccine
Description:
Routine dosing form and dosage
Arm group label:
Extended schedule
Arm group label:
Routine schedule
Other name:
Gardasil9
Summary:
There are very little data on human papillomavirus (HPV) vaccination among the 18 million
women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV
and the resultant cervical cancer. Particularly, there are no data to date on
reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very
little data on the 9vHPV vaccine in this population overall. It is critical to examine
the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been
discontinued. Additionally, in order to reach the World Health Organization's global goal
of cervical cancer elimination, we must determine the role of various HPV prevention
strategies in this important population including reduced vaccine dosing which can
drastically increase the feasibility of HPV vaccination programs globally.
This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not
previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3
doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an
expanded schedule of 0/6 months with a third dose at month 12 to adhere to current
recommendations for WLWH. We will compare the immune response generated to two versus
three doses of 9vHPV vaccine and will follow participants for 2 years to examine the
immune response over time.
This study, which builds upon our team's prior work on HPV vaccination in WLWH, will
determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and
will examine additional aspects of HPV vaccination in WLWH including the immune response
to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV
samples in this population. These data will inform global public health policy and
programming and will inform the global strategy for cervical cancer elimination.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Living with HIV
- Has a uterine cervix
Exclusion Criteria:
- Unable to give fully informed consent
- Pregnant or unwilling to avoid pregnancy during vaccination
- Allergy to the vaccine or its components
- Prior receipt of any HPV vaccine
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of British Columbia
Address:
City:
Vancouver
Zip:
V6H 2N1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Deborah Money, MD
Phone:
6048752194
Email:
deborah.money@ubc.ca
Contact backup:
Last name:
Emma Karlsen, BSc
Phone:
604-875-2424
Phone ext:
6379
Email:
emma.karlsen@cw.bc.ca
Investigator:
Last name:
Deborah Money, MD
Email:
Principal Investigator
Facility:
Name:
Health Sciences Centre
Address:
City:
Winnipeg
Zip:
R3A1R9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Dozie Ochular
Phone:
204-975-7723
Email:
Dozie.Ochulor@umanitoba.ca
Contact backup:
Last name:
Sudharsana R Ande, PhD
Phone:
204-975-7723
Email:
sande@hsc.mb.ca
Investigator:
Last name:
Vanessa Poliquin, MD
Email:
Principal Investigator
Facility:
Name:
Hamilton Health Sciences
Address:
City:
Hamilton
Zip:
L8S1A4
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Mariana Rusler, BSc Psych., CCRA
Phone:
905-521-2100
Phone ext:
73443
Email:
rusler@hhsc.ca
Investigator:
Last name:
Shariq Haider, MD
Email:
Principal Investigator
Facility:
Name:
St. Michael's Hospital
Address:
City:
Toronto
Zip:
M5B1W8
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Klaudia Szczech, MSc
Phone:
416-867-7460
Phone ext:
49092
Email:
klaudia.szczech@unityhealth.to
Contact backup:
Last name:
Arifa Rahman, M.B.B.S, MPH
Phone:
416-867-7460
Phone ext:
48047
Email:
arifa.rahman@unityhealth.to
Investigator:
Last name:
Mark Yudin, MD
Email:
Principal Investigator
Facility:
Name:
Toronto General Hospital
Address:
City:
Toronto
Zip:
M5G2C4
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Adriana D'Aquila, R.N.
Phone:
416-340-4800
Phone ext:
8170
Email:
Adri.DAquila@uhn.ca
Investigator:
Last name:
Sharon Walmsley, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Universitaire Sainte-Justine
Address:
City:
Montréal
Zip:
H3T1C5
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Hasna Meddour
Phone:
514-345-4931
Phone ext:
7169
Email:
Hasna.Meddour@recherche-ste-justine.qc.ca
Contact backup:
Last name:
Suzanne Taillefer, PhD
Email:
suzanne.taillefer.hsj@ssss.gouv.qc.ca
Investigator:
Last name:
Isabelle Boucoiran, MD
Email:
Principal Investigator
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A3J1
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Nathalie Paisible, R.N.
Phone:
514-934-1934
Phone ext:
32537
Email:
nathalie.paisible@muhc.mcgill.ca
Contact backup:
Last name:
Hansi Peiris
Phone:
514-934-1934
Phone ext:
32547
Email:
hansi.peiris@muhc.mcgill.ca
Investigator:
Last name:
Marina Klein, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier de l'Université Laval
Address:
City:
Québec
Zip:
G1V4G2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Isabelle Chabot
Phone:
418-525-4444
Phone ext:
47778
Email:
isabelle.chabot@crchudequebec.ulaval.ca
Contact backup:
Last name:
Geneviève Gagnon, R.N.
Phone:
418-525-4444
Phone ext:
48914
Investigator:
Last name:
Marie-Louise Vachon, MD
Email:
Principal Investigator
Facility:
Name:
Regina General Hospital
Address:
City:
Regina
Zip:
S4P0W5
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Danielle Myrah, RN, BScN
Phone:
306-766-3915
Email:
Danielle.Myrah@saskhealthauthority.ca
Contact backup:
Last name:
Sarah Craddock, CHIM
Phone:
306-766-0576
Email:
Sarah.Craddock@saskhealthauthority.ca
Investigator:
Last name:
Alexander Wong, MD
Email:
Principal Investigator
Start date:
July 27, 2023
Completion date:
August 2026
Lead sponsor:
Agency:
University of British Columbia
Agency class:
Other
Source:
University of British Columbia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495906
