This study aims to better understand how the HPV vaccine works in girls and women living with HIV over the long term and to learn how the HPV vaccine can be provided to best protect girls and women living with HIV from HPV infection and associated cervical disease, cervical cancer, and genital warts.
Principal Investigator: Dr Deborah Money
About the study: Human papillomavirus (HPV) is a common sexually transmitted infection, with approximately 3/4 Canadians infected during their lifetime. Although HPV is the leading cause of cervical cancer and genital warts, the majority of HPV infections clear on their own and do not lead to cervical cancer. This study extends follow-up of girls and women who received a least one dose of quadrivalent human papillomavirus (qHPV) vaccine through the first phase of this research. The quadrivalent vaccine protects against four of the most common types of HPV associated with genital warts and cervical cancer: HPV 6, 11, 16 and 18. Three-hundred-and-fifty-three girls and women from across Canada who received the qHPV vaccine in the first phase of this research were eligible to participate. Participants were asked to complete approximately 3 annual study visits. At each visit, participant health status was reviewed and blood samples and vaginal swabs were taken to assess response to the HPV vaccine and efficacy of the vaccine in preventing HPV infection and associated diseases over time.
Why is this research important? This research is important because, while the HPV vaccine has been studied extensively in women and girls without HIV, this is one of the first projects to investigate response to the HPV vaccine in girls and women living with HIV. Generally, persons living with HIV do not respond as well to standard vaccines compared to persons without HIV. Further, Women with HIV are more vulnerable to HPV infection and more likely to progress from HPV infection to cervical cancer. Cervical cancer is responsible for approximately 266,000 deaths globally per year. This research can help us better understand how the quadrivalent HPV vaccine works in girls and women living with HIV over the long term. We hope to learn how the vaccine can be provided to best protect girls and women living with HIV from HPV infection and associated cervical disease and genital warts.
Study status: As this study is specifically for long term follow-up, recruitment was limited to girls and women who participated in the first phase of this research. As of June 2019 the last study visit is complete with 241 women re-engaged to the project and 581 visits complete.
Media:
Note: The Canadian HIV Trials Network (CTN) provides ongoing updates on this study, on a “CTN 236” page on their website: : http://www.hivnet.ubc.ca/clinical-trials/ctn236/
- “Higher risk of HPV vaccine failure in the first two years for women living with HIV”. SmartSex Resource blog post (2018)
- “HPV vaccine shows higher failure rate in girls or women living with HIV”. University of British Columbia Faculty of Medicine (2018)
- “Failure Rates for HPV Vaccine Higher in HIV-Positive Women, Girls”. Clinical Advisor (2018):
- Canadian HIV Trials Network (CTN) article on adult participants’ response to the vaccine (2016)
- Read on the CTN website.
- CATIE article on adult participants’ response to the vaccine (2016)
- Read on the CATIE website.
- Read on “TheBodyPro” website.
- Annual review (2017)
- Read on the WHRI website.
- Interview by Suzanne MacCarthy. The Positive Side Magazine. Will the HPV Vaccine Guard You? Spring/Summer 2009, PAGES 13-14
- Read on the CATIE website.
Study results/publication: Data analysis for this study is ongoing. In the first phase of this research, the HPV vaccine was well tolerated, with no safety concerns identified. All girls and almost all women who were vaccinated showed an initial immune response to the 4 HPV types in the vaccine. This initial immune response is a promising indicator that qHPV vaccine can help protect girls and women living with HIV from HPV infection. The immune response seen in women living with HIV was comparable to the immune response in published studies of women without HIV. Rates of new quadrivalent HPV infection (including HPV 6, 11, 16, and 18), genital warts and precancerous changes to the cervix in the 2 years following vaccination were lower than expected rates for women living with HIV, further demonstrating short-term efficacy of the HPV vaccine in women living with HIV.
Girls ages 9-14 did not produce as strong an immune response to the vaccine compared to similarly aged girls without HIV. In both women and girls, participants with a fully suppressed HIV viral load had greater immune responses to the qHPV vaccine. Longer term follow-up is important to better understand the efficacy of the qHPV vaccine in girls and women who are a living with HIV over time. Longer term results will be shared in future as study results are further analyzed. Ongoing cervical cancer screening remains important in women living with HIV.
Related publications:
Money D, Moses E, Blitz S, Vandriel SM, Lipsky N, Walmsley SL, Loutfy M, Trottier S, Smaill F, Yudin M, Klein M, Harris M, Cohen J, Wobeser W, Bitnun A, Lapointe N, Samson L, Brophy J, Karatzios C, Ogilvie G, Coutlée F, Raboud J; the HPV in HIV Study Group. HIV viral suppression results in higher antibody responses in HIV-positive women vaccinated with the quadrivalent human papillomavirus vaccine. Vaccine. 2016 Sep,34(4). 4799-806. PMID:27544584
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, Money D; the HPV in HIV Study Group. Immunogenicity and Safety of the qHPV Vaccine in HIV Positive Girls. Pediat Infect Dis J. 2018 Jun;37(6):595-7. 10.1097/INF.0000000000001874.
McClymont E, Lee M, Raboud JM, Coutlée F, Walmsley SL, Lipsky N, Loutfy MR, Trottier S, Smaill F, Klein MB, Harris M, Cohen J, Yudin MH, 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 epub ahead of print.. doi:10.1093/cid/ciy575.
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. 2020 January: E-pub ahead of print.
E McClymont, M Lee, C Elwood, S Mitchell-Foster, J van Schalkwyk, G Ogilvie, and D Money. Cervical Cancer Screening in Immunocompromised Women. JOGC. 2019 August; 41(8): 1177-1180.
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.
Clinical sites include: Oak Tree Clinic, BC Women’s Hospital and Health Centre, Vancouver, BC; St. Paul’s Infectious Disease Clinic, Vancouver, BC; Toronto General Hospital, Toronto, ON; Maple Leaf Medical Clinic, Toronto, ON; St. Michaels Hospital, Toronto, ON; Hospital for Sick Children, Toronto, ON; McMaster University Hospital, Hamilton, ON; Kingston General, Kingston, ON; Children’s Hospital of Eastern Ontario, Ottawa, ON; HIV Care Program, Windsor, ON; McGill University Health Centre, Montreal, QB; Montreal Children’s Hospital, Montreal, QB; CHU Sainte Justine, Montréal, QB; Centre Hospitalier de l’Université Laval, Québec City, QB;
Statistical Analyses: Current: Dr Arianne Albert (current), Women’s Health Research Institute Former: Dr Janet Raboud & Ms Sandra Blitz, University Health Network
Data Management: Canadian HIV Trials Network
Lab Analyses: Dr. Francois Coutlee, University of Montreal; Dr. Janet Hill, University of Saskatchewan; British Columbia Centre for Disease Control; Merck (pharmaceuticals).