Quadrivalent vaccine evaluation study (QUEST)

QUEST (Quadrivalent HPV Vaccine Evaluation Study) is a Canada-wide study designed to evaluate whether 2 doses of the HPV vaccine are just as effective as 3 doses at preventing Human Papillomavirus (HPV) infection and cervical cancer.

Principal Investigators: Drs. Gina Ogilvie, Simon Dobson

Primary Contact: QUESTION Coordinating Centre, 604.875.2636 (Toll Free: 1-866-502-2424), questhpvstudy@cfri.ca

About the Study: QUEST (Quadrivalent HPV Vaccine Evaluation Study) is a Canada-wide study designed to evaluate whether 2 doses of the HPV vaccine are just as effective as 3 doses at preventing Human Papillomavirus (HPV) infection and cervical cancer. The QUEST study will seek to recruit 8,666 females from across between the ages of 14 to 18.  Study sites are in British Columbia, Alberta, Quebec, Nova Scotia, and PEI.

Why is the study important? A 2 dose schedule instead of 3 doses of the HPV vaccine means girls would  have to endure fewer shots and the program could be extended to more people including boys.  Fewer doses means that middle and lower income countries are more likely to be able to afford the HPV vaccine program.

Who can participate? Females 14-18 years old who received either 2 or 3 doses of the HPV vaccine on the provincial schedule who are located in BC, Alberta, Quebec, PIE or Nova Scotia.

What does participation involve? Participating is quick and simple and can be done from anywhere.  Participants are enrolled in the study for 5 years and involves completing an online survey  once a year and providing self collected swabs twice a year

Study Results/Publication: 

Ogilvie GS, Naus M, Money DM, Dobson SR, Miller D, Krajden M, van Niekerk DJ, Coldman AJ. Reduction in cervical intraepithelial neoplasia in young women in British Columbia after introduction of the HPV vaccine: An ecological analysis. Int J Cancer. 2015;137(8):1931-7.

Krajden M, Cook D, Yu A, Chow R, Su Q, Mei W, McNeil S, Money D, Dionne M, Palefsky J, Karunakaran K, Kollmann T, Ogilvie G, Petric M, Dobson S. Assessment of HPV 16 and HPV 18 antibody responses by pseudovirus neutralization, Merck cLIA and Merck total IgG LIA immunoassays in a reduced dosage quadrivalent HPV vaccine trial. Vaccine. 2014;32(5):624-30.

Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, Langley JM, Bettinger JA, Singer J, Money D, Miller D, Naus M, Marra F, Young E. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013;309(17):1793-802.

Co-Investigators: Mel Krajden, Joel Singer, Marie Helene Mayrand, Shelly McNeil, Chantal Sauvageau, Vladmir Gilca, James Kellner, Deborah Money

Funded by: MSFHR, CIHR

Partners: UBC, CFRI, Dalhousie University, University of Calgary, Centre Hospitalier Universitaire de Quebec

Websites:

http://questhpvstudy.ca/contact-us/

http://questhpvstudy.ca/

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

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.

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.

News:

  • Canadian HIV Trials Network (CTN) article on adult participants’ response to the vaccine (2016)
  • Interview by Suzanne MacCarthy. The Positive Side Magazine. Will the HPV Vaccine Guard You? Spring/Summer 2009, PAGES 13-14

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).

CARMA-1-PREG

CARMA-1-PREG is investigating factors related to pre-term deliveries among HIV positive women.

Principal Investigator: Dr. Deborah Money

Mitochondrial and Telomere Studies in Pregnancy
– AND –
Placental Mitochondrial Toxicity in HIV Therapy during Pregnancy
– AND –
Measuring Mitochondrial Aging, Application to HIV Infection and Therapy AND Cellular Aging and HIV Comorbidities in Women and Children

(CARMA-1-PREG)


Primary Contact: Evelyn Maan, Research Manager, 604-875-2000 ext. 2463, emaan@cw.bc.ca

About the study: CARMA-1-PREG is investigating factors related to pre-term deliveries among HIV positive women. Research has shown that HIV+ pregnant women are 2x more likely to deliver their babies early (more than 3 weeks before their due dates), compared to women without HIV. The purpose of CARMA-1-PREG is to study the effects of particular anti-HIV medications on pregnant women and on their infants by examining two markers of cell function: the length of DNA at the ends of chromosomes (“telomeres”) and the energy producing parts of the cell (“mitochondrial DNA”). CARMA-1-PREG also investigates how HIV, anti-HIV medications and other factors (e.g. the bacterial environment of a pregnant woman’s vagina) may affect early delivery.

Why is this research important?  Anti-HIV medication has dramatically reduced the risk of infants getting HIV from their HIV+ mothers (from 25% to less than 1%). However, research has demonstrated that HIV+ pregnant women are twice as likely to have a pre-term delivery when compared to women without HIV. Better understanding the factor(s) which cause these pre-term deliveries among HIV+ women is integral to the health of mothers and infants living with or exposed to HIV.

Study status: Recruiting

Who can participate: Pregnant women living with HIV who are taking, or are going to be taking, anti-HIV medication during their pregnancy.

Study Results/Publications: 

Money DM, Wagner EC, Maan EJ, Chaworth-Musters T, Gadawski I, van Schalkwyk JE, Forbes JC, Burdge D, Albert AYK, Lohn Z, Côté HCF, and The Oak Tree Clinic Research Group “Evidence of subclinical mtDNA alterations in HIV-infected pregnant women receiving combination antiretroviral therapy compared to HIV-negative pregnant women” PLoS One. 2015 Aug 6;10(8):e0135041. doi: 10.1371/journal.pone.0135041. eCollection 2015.

Imam T, Jitratkosol MH, Soudeyns H, Sattha B, Gadawski I, Maan E, Forbes JC, Alimenti A, Lapointe N, Lamarre V, Money DM, Côté HC; CIHR Emerging Team Grant on HIV Therapy and Aging: CARMA. Leukocyte telomere length in HIV-infected pregnant women treated with antiretroviral drugs during pregnancy and their uninfected infants. J Acquir Immune Defic Syndr. 2012 Aug 15;60(5):495-502. PMID: 22580562

Jitratkosol MH, Sattha B, Maan EJ, Gadawski I, Harrigan PR, Forbes JC, Alimenti A, van Schalkwyk J, Money DM, Côté HC; CIHR Emerging Team Grant on HIV Therapy and Aging (CARMA). Blood mitochondrial DNA mutations in HIV-infected women and their infants exposed to HAART during pregnancy. AIDS. 2012 Mar 27;26(6):675-83. PMID: 22436539

Co-Investigators: Dr. Helene Cote, Dr. Julie van Schalkwyk, Dr. Isabelle Boucoiran, Dr. Melanie Murray, Dr. Ariane Alimenti, Dr. Neora Pick

Funded by: CIHR

Partners: Positive Women’s Network

CARMA 1 Participant Consent Form

CARMA 7: Bone and Renal Outcomes in HIV-Exposed, Uninfected Infants with Perinatal Exposure to Tenofovir

The purpose of CARMA 7 is to investigate how fetal exposure to the anti-HIV medication Tenofovir may affect the bone and kidney health of infants who are born to HIV+ women.

Principal Investigator: Dr. Ariane Alimenti

Primary Contract: Evelyn Maan, Research Manager, 604-875-2000 ext. 2463, emaan@cw.bc.ca

About the Study: Anti-HIV medication has reduced the risk of HIV transmission from mother to child from 25% to less than 1%. However, the effects of some of these anti-HIV medications on the developing fetus have not yet been thoroughly studied. One medication in particular, called “Tenofovir”, can cause some bone and kidney problems for HIV+ adults when taken for a long time, especially with existing bone and kidney diseases. The purpose of CARMA 7 is to investigate how fetal exposure to Tenofovir may affect the bone and kidney health of infants who are born to HIV+ women.

Why is this research important? The use of Tenofovir is becoming far more common in anti-HIV medication regimens because it is so well tolerated. As a result, an increasing number of women are getting pregnant while taking this particular medication (almost 25% of HIV+ pregnancies in BC in 2011). Accordingly, it is very important for the current and future health of infants born to HIV+ women to study the effects of this anti-HIV medication.

Study Status: Recruiting

Who can participate:  Infants who do not have HIV, born at term (>35 weeks +2 days) to an HIV+ mother who took anti-HIV medication during her pregnancy, specifically Tenofovir, Abacavir, or Zidovudine (the last two for the control group).  Infants have visits for the CARMA-7 study at 1 month, 6 months, and 18 months of age.

Co-Investigators: Dr. Helene Cote, Dr. Deborah Money, Dr. Laura Sauve, Dr. Jason Brophy

Funded by: CIHR, Canadian HIV Trials Network

CARMA 7 Participant Consent Form