Project Title: A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living with HIV (The NOVA-HIV Study)
Principal Investigator: Dr. Deborah Money
About the study: The goal of this study is to explore reduced dosing of the nonavalent HPV vaccine in women living with HIV (WLWH). This study will determine whether two doses of 9vHPV vaccine can be used in women living with HIV 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. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or at an extended schedule of 0/6/12 months. These data will inform global public health policy and programming as well as informing the global strategy for cervical cancer elimination.
Study status: Currently recruiting out of Oaktree Clinic at BC Women's Hospital in Vancouver, BC and Le Centre Hospitalier Universitaire de Québec in Québec City, QC. Other recruitment sites across Canada will begin recruiting in early 2024.
Co-Investigators & Collaborators: Dr. Elizabeth McClymont (University of British Columbia), Dr. Chelsea Elwood (Oak Tree Clinic, BC Women's Hospital), Alicia Hornsberger, NP (Oak Tree Clinic, BC Women's Hospital), Dr. Julie van Schalkwyk (Oak Tree Clinic, BC Women's Hospital), Dr. Shariq Haider (McMaster University Hospital, Hamilton), Dr. Sharon Walmsley (Toronto General Hospital, Toronto), Dr. Mark Yudin (St. Michael's Hospital, Toronto), Dr. Vanessa Poliquin (Health Sciences Centre, Winnipeg), Dr. Isabelle Boucoiran (Centre Hospitalier Universitaire Sainte-Justine, Montréal), Dr. Valerie Martel-Laferrière (Centre Hospitalier de l’Université de Montréal (CHUM), Montréal), Dr. Marina Klein (McGill University Health Centre, Montréal), Dr. Marie-Louise Vachon (Centre Hospitalier de Québec-Université Laval, Québec City), Dr. Alexander Wong (Regina Qu'Appelle Health Region, Regina,), Dr. Marette Lee (University of British Columbia), Dr. Dirk van Niekerk (BC Cancer), Dr. Jason Brophy (University of Ottawa, Ottawa), Dr. Catherine Hankins (McGill University Health Centre, Montréal), Dr. Mona Loutfy (Maple Leaf Medical Clinic, Toronto), Dr. Alicia Berard (Health Sciences Centre, Winnipeg), Dr. Manish Sadarangani (Vaccine Evaluation Centre, Vancouver), Dr. Suzanne Gibbons (National Microbiology Lab, Winnipeg), Dr. Aida Sivro (National Microbiology Lab, Winnipeg), Dr. Mel Krajden (BC Centre for Disease Control, Vancouver), Dr. Joel Singer (Canadian HIV Trials Network)
Funded by: Canadian Institutes of Health Research and further supported by the Canadian HIV Trials Network.
Project Title: Long Term Follow-Up Study of CTN 236 – A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women
Principal Investigator: Dr. Deborah Money
About the study: This study aims to better understand how the HPV vaccine works in HIV positive girls and women over the long term and to clarify how care can be provided to best protect this population from HPV infection and associated cervical cancer and genital warts. Infection with human papillomavirus (HPV) is the leading cause of cervical cancer and genital warts. This study extends follow-up of girls and women living with HIV who received a least one dose of quadrivalent human papillomavirus (HPV) vaccine through the first phase of this research. 353 girls and women from across Canada are therefore eligible and are asked to participate in 3 approximately annual study visits. At each visit, participant health status is reviewed and blood samples and vaginal swabs are taken to assess response to the HPV vaccine and efficacy of the vaccine in preventing HPV infection and associated diseases over time.
Study status: As of June 2019 last visit is complete with 241 women re-engaged to the project and 580 visits complete.
Co-Investigators & Collaborators: Dr. Neora Pick (University of British Columbia), Dr. Mel Krajden (University of British Columbia), Dr. Gina Ogilvie (University of British Columbia), Dr. Simon R.M. Dobson (University of British Columbia), Dr. Marianne Harris (University of British Columbia), Dr. Fiona Smaill (McMaster University), Dr. Lindy Samson (Children’s Hospital of Eastern Ontario), Dr. Sean Ari Bitnun (University of Toronto), Dr. Mona Loutfy (Women’s College Research Institute), Dr. Fatima Kakkar (Universite de Montreal), Dr. Mark Yudin (University of Toronto), Dr. Sharon Walmsley (University of Toronto), Dr. Marina Klein (McGill University), Dr. Francois Coutlee (Universite de Montreal), Dr. Janet Hill (University of Saskatchewan), Dr. Janet Raboud (University of Toronto), Dr. Wendy Wobeser (Queen’s University), Dr. Sylvie Trottier (Universite Laval), Dr. Catherine Hankins (University of Amsterdam), Dr. Normand Lapointe (Hopital Sainte Justine), Dr. Darrell Tan (University of Toronto), Dr. Jason Brophy (University of Ottawa), Dr. Andrew Coldman (BC Cancer Agency), Dr. Angela Kaida (Simon Fraser University), Dr. Arianne Alimenti (University of British Columbia), Dr. Christos Karatzios (University of Montreal), Dr. Dirk van Niekirk (BC Cancer Agency), Dr. Jan Christilaw (BC Women’s Hospital and Health Centre), Dr. Jeff Cohen (HIV Care Program, Ontario), Dr. Joel Singer (Canadian HIV Trials Network), Dr. Julie van Schalkwyk (University of British Columbia), Ms. Laurie Edmiston (CATIE), Ms. Marcie Summers (Positive Women’s Network).
Funded by: Canadian Institutes of Health Research and further supported by the Canadian HIV Trials Network.
Project Title:The Impact of the HPV Vaccine on Preterm Birth in British Columbia
Principal Investigator: Dr. Chelsea Elwood
Primary Contact: Chelsea Elwood, B.M.ScH, M.Sc, MD, FRCSC, Reproductive Infectious Diseases Specialist, Medical Lead Antimicrobial Stewardship, Department of Obstetrics and Gynecology, University of British Columbia Chelsea.Elwood@cw.bc.ca
About the Study: Recent evidence has suggested that HPV vaccination may reduce the risk of preterm birth. It is important to determine if this is also the case in British Columbia. This project will determine the feasibility of linking existing provincial databases that contain information on HPV vaccination status and details of pregnancy and delivery to begin to understand if the risk of preterm birth is lower in HPV-vaccinated women. This catalyst project will foster future research utilizing the same linkage and will allow us to continue to assess reproductive outcomes associated with HPV vaccination in the coming years. The pilot data generated will allow us to seek additional funding for a larger Canadian study answering the same question on a national scale. If the risk of preterm birth is reduced by HPV vaccination, this knowledge can directly benefit women and provide public health officials with an additional angle to promote vaccination. In addition, vaccination against HPV could result in improved reproductive outcomes both nationally and globally for women and their infants.
Study Status: Data analysis
Co-Investigators: Dr. Elisabeth McClymont, Dr. Gina Ogilvie, Dr. Marette Lee, Dr. Deborah Money
Funded by: BC Women’s Health Foundation
2020
Lukac CD, Donken R, Otterstatter M, Mazo O, Wong S, Marra F, Smith L, Naus M, Money D, Krajden M, Grennan T, Gilbert M, Wong J, Ogilvie GS. Impacts of Human Papillomavirus Immunization Programs on Rates of Anogenital Warts in British Columbia, Canada, 2000 to 2017. Sex Transm Dis. 2020 Oct;47(10):691-697. doi: 10.1097/OLQ.0000000000001235. PMID: 32649583.
Donken R, Dobson SRM, Marty KD, Cook D, Sauvageau C, Gilca V, Dionne M, McNeil S, Krajden M, Money D, Kellner J, Scheifele DW, Kollmann T, Bettinger JA, Liu S, Singer J, Naus M, Sadarangani M, Ogilvie GS. Immunogenicity of 2 and 3 Doses of the Quadrivalent Human Papillomavirus Vaccine up to 120 Months Postvaccination: Follow-up of a Randomized Clinical Trial. Clin Infect Dis. 2020 Aug 14;71(4):1022-1029. doi: 10.1093/cid/ciz887. PMID: 31617568; PMCID: PMC7428395.
McClymont E, Lee M, Raboud J, Coutlée F, Walmsley S, Lipsky N, Loutfy M, Trottier S, Smaill F, Klein MB, Harris M, Cohen J, Yudin MH, Wobeser W, Money D. Prevalent and persistent oncogenic HPV types in a cohort of women living with HIV prior to HPV vaccination. Int J Gynaecol Obstet. 2020 Jul;150(1):108-115. doi: 10.1002/ijgo.13185. Epub 2020 Jun 3. PMID: 32342504.
E McClymont, G Ogilvie, A Albert, A Johnston, J Raboud, S Walmsley, N Lipsky, M Loutfy, S Trottier, F Smaill, MH Yudin, MB Klein, M Harris, W Wobeser, A Bitnun, F Kakkar, L Samson, J Brophy, C Karatzios, and D Money for the CTN 236 HPV in HIV Study Team. Immunological Impact of Quadrivalent HPV Vaccine Dose Spacing in Women Living with HIV. Vaccine. February 2020: In press.
Link for Publication Access Pending
McClymont E, Coutlée F, Lee M, Albert A, Raboud J, Walmsley S, Lipsky N, Loutfy M, Trottier S, Smaill F, Klein MB, Cohen J, Yudin MH, Harris M, Wobeser W, Bitnun, A, Samson L, and Money D for the CTN 236 HPV in HIV Study Team. Persistence of Non-Vaccine Oncogenic HPV Serotypes in Quadrivalent HPV-Vaccinated Women Living with HIV. JAIDS. Jan 2020 January: E-pub ahead of print.
McClymont E, Lee M. Intraoperative human papillomavirus testing: earlier prediction of treatment failure. BJOG. 2020 Jan;127(1):106. doi: 10.1111/1471-0528.15969. Epub 2019 Oct 17. PMID: 31571373.
2019
Donken R, Dobson S, Marty KD, Cook D, Sauvageau C, Gilca V, Dionne M, McNeil S, Krajden M, Money D, Kellner J, Scheifele DW, Kollmann T, Bettinger JA, Liu S, Singer J, Naus M, Sadarangani M, Ogilvie GS. Immunogenicity of 2 and 3 Doses of the Quadrivalent Human Papillomavirus Vaccine up to 120 Months Postvaccination: Follow-up of a Randomized Clinical Trial. Clin Infect Dis. 2019 Sep 6. pii: ciz887. doi: 10.1093/cid/ciz887. [Epub ahead of print]
Elisabeth McClymont, Marette Lee, Chelsea Elwood, Sheona Mitchell-Foster, Julie van Schalkwyk, Gina Ogilvie, Deborah Money. Cervical Cancer Screening in Immunocompromised Women. JOGC. 2019 Aug; 41(8): 1177-1180 2019 Aug; 41(8): 1177-1180 DOI: ttps://doi.org/10.1016/j.jogc.2019.03.005
2018
McClymont E, Lee M, Raboud J, Coutlee F, Walmsley S, Lipsky N, Loutfy M, Trottier S, Smaill F, Klein MB, Harris M, Cohen J, Yudin M, Wobeser W, Money D & CTN 236 HPV in HIV Study Team. “The Efficacy of the Quadrivalent Human Papillomavirus Vaccine in Girls and Women Living with HIV”. Clin Infect Dis. 2018 Jul 7. doi: 10.1093/cid/ciy575.
Moses E, Pedersen H, Wagner EC, Sekikubo M, Money DM, Ogilvie G, Mitchell-Foster SM. Understanding Men's Perceptions of Human Papillomavirus and Cervical Cancer Screening in Kampala, Uganda. J Glob Oncol. 2018 Sep;(4):1-9. doi: 10.1200/JGO.17.00106.
Marie Jones, Marette Lee, Gina Ogilvie, Melanie C. M. Murray, Deborah Money, Rebecca Collins, Arianne Albert, Sheona Mitchell-Foster. Identifying Barriers to Treatment for Women With Cervical Dysplasia in Rural Northern British Columbia”. J Obstet Gynaecol Can. 2018 Nov;40(11):1401-1408. doi: 10.1016/j.jogc.2018.02.009. Epub 2018 Jun 29
2017
Mitchell-Foster S, Pederson H, Eng Stime E, Sekikubo M, Moses E, Mwesigwa D, Biryabarema C, Christilaw J, Bysmugisha J, Money D, Ogilvie G. (2017). Self-collection based HPV testing for cervical cancer screening among women living with HIV in Uganda: a descriptive analysis of knowledge, intentions to screen, and factors associated with HPV positivity. BMC Women's Health. 17(2):4
Ogilvie G, Sauvageau C, Dionne M, McNeil S, Krajden M, Money D, Dobson S. (2017). Immunogenicity of 2 vs 3 Doses of the Quadrivalent Human Papillomavirus Vaccine in Girls Aged 9 to 13 Years After 60 Months. JAMA. 317(16): 1687-1688.
Brophy J, Bitnun A, Alimenti A, Lapointe N, Samson L, Read S, Karatzios C, Dobson S, Moses E, Blitz S, Lipsky N, Ogilvie O, Walmsley S, Raboud J, and Money D for the HPV in HIV Study Group. Immunogenicity and Safety of the Quadrivalent Human Papillomavirus Vaccine in Girls Living with HIV. The Pediatric Infectious Disease Journal. June 2018 - Volume 37 - Issue 6 - p 595–597 doi: 10.1097/INF.0000000000001874
2016
Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, Garland SM, Chatterjee A, Lazcano-Ponce E, Salmer J, McNeil S, Stapleton JT, Bouchard C, Martens MG, Money DM, Quek SC, Romanowski B, Vallejos CS, Ter Harmsel B, Prilepskaya V, Fong KL, Kitchener H, Minkina G, Lim YK, Stoney T, Chakhtoura N, Cruickshank ME, Savicheva A, da Silva DP, Ferguson M, Molijn AC, Quint WG, Hardt K, Descamps D, Suryakiran PV, Karkada N, Geeraerts B, Dubin G, Struyf F; VIVIANE Study Group. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet Infect Dis. 2016 Jun 28. pii: S1473-3099(16)30120-7. doi: 10.1016/S1473-3099(16)30120-7
Mitchell SM, Pedersen HN, Sekikubo M, Biryabarema C, Byamugisha JK, Mwesigwa D, Steinberg M, Money DM, Ogilvie GS. Strategies for community education prior to clinical trial recruitment for a cervical cancer screening intervention in Uganda. Oncol. 2016 Apr 13;6:90. doi: 10.3389/fonc.2016.00090.
2015
Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A. Broad Spectrum HPV Vaccine Study. (DM Money)Collaborators (227) A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044
Ogilvie G, Naus M, Money DM, Dobson SR, Miller D, Krajden M, van Niekerk DJ, Coldman AJ. Reduction in cervical dysplasia in young women in British Columbia after introduction of the HPV vaccine: An ecological analysis. Int J Cancer. 2015 Mar 6. doi: 10.1002/ijc.29508.
Moses E, Pedersen HN, Mitchell SM, Sekikubo M, Mwesigwa M, Singer J, Biryabarema C, Byamugisha JK, Money DM, Ogilvie GS. Uptake of community-based, self-collected HPV testing vs. visual inspection with acetic acid for cervical cancer screening in Kampala, Uganda: preliminary results of a randomised controlled trial. Tropical Medicine and International Health 2015 May 29. doi: 10.1111/tmi.12549.
Skinner SR, Wheeler CM, Romanowski B, Lazcano-Ponce E, Del Rosario-Raymundo MR, Vallejos C, Minkina G, Da Silva DP, McNeil S, Prilepskaya V, Gogotadze I, Money D, Garland SM, Romanenko V, Harper DM, Levin MJ, Chatterjee A, Geeraerts B, Struyf F, Dubin G, Bozonnat MC, Rosillon D, Baril L; VIVIANE study group. Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study. Int J Cancer. 2015 Dec 19. doi: 10.1002/ijc.29971.