Long Term Follow-up Study of CTN 236 – A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women

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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

Primary Contact: Nancy Lipsky, WHRI Research Manager, 604 875 2000 x4877, NLipsky@cw.bc.ca

About the study: Infection with human papillomavirus (HPV) is the leading cause of cervical cancer and genital warts.  This study extends follow-up of girls and women who received a least one 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.

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 have four times higher rates of HPV infection and are much more likely to progress from 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 vaccine works in HIV positive girls and women over the long term and can clarify how care can be provided to best protect this population from HPV infection and associated cervical cancer and genital warts.

Study status: Recruitment is limited to girls and women who participated in the first phase of this research.  Eligible women will be recruited throughout the study duration.

Who can participate: Those who 1) received at least one HPV vaccine through CTN 236, phase 1 and 2) who are able to give fully informed consent or assent.

Study results/publication: Enrollment and data collection for this follow-up study are ongoing and results are pending.  However, in the first phase of this research, the HPV vaccine was well tolerated, with no safety concerns identified.  Girls and women showed a solid immune response to the vaccine- this suggests ability of the vaccine to protect HIV positive girls and women from HPV infection.  Observed low rates of new HPV infection, genital warts and precancerous changes to the cervix in the 2 years following vaccination further reflect short-term efficacy of the HPV vaccine in this group.  Girls ages 9-14 did not produce as strong an immune response to the vaccine as did comparable girls without HIV; longer term follow up is important to better understand the level of protection provided by the HPV vaccine to girls and women who are a living with HIV.

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: Dr. Janet Raboud, 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).