Elisabeth McClymont1, Marette Lee1, Janet Raboud2,3, François Coutlée4, Sharon Walmsley2,5, Nancy Lipsky6, Mona Loutfy7, Sylvie Trottier8, Fiona Smaill9, Marina B Klein10, Marianne Harris11, Jeffrey Cohen12, Mark H Yudin7,13, Wendy Wobeser14, Deborah Money1. 1. Department of Obstetrics and Gynecology, University of British Columbia, Vancouver. 2. Toronto General Hospital Research Institute, University Health Network, Ontario. 3. Dalla Lana School of Public Health, University of Toronto, Ontario. 4. Département de Microbiologie Médicale et Infectiologie, l'Université de Montréal, Québec. 5. Department of Medicine, University of Toronto, Ontario. 6. Women's Health Research Institute, Vancouver, British Columbia. 7. Women's College Research Institute, University of Toronto, Ontario. 8. Infectious Diseases Research Centre, Université Laval, Québec City, Québec. 9. Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario. 10. McGill University Health Centre, Montreal, Québec. 11. British Columbia Centre for Excellence in HIV/AIDS, Vancouver. 12. Windsor Regional Hospital HIV Care Program, Ontario, Canada. 13. Department of Obstetrics and Gynecology, St. Michael's Hospital, University of Toronto, Ontario, Canada. 14. Department of Medicine, Queen's University, Kingston, Ontario, Canada.
Abstract
BACKGROUND: Human papillomavirus (HPV) vaccination is safe and efficacious in women without human immunodeficiency virus (HIV). Although good immunogenicity has been observed in women living with HIV (WLWH), efficacy data in this population are needed. METHODS: We enrolled 420 females aged ≥9 years (range, 9-65) living with HIV. Participants were to receive 3 doses of qHPV vaccine (0/2/6 months). The main endpoint was vaccine failure (ie, incident persistent qHPV infection, cervical intraepithelial neoplasia of grade 2 or higher [CIN2+], or genital warts). We compared these rates to published rates in vaccinated and unvaccinated women without HIV as well as unvaccinated WLWH. RESULTS: Among 279 eligible women, median follow-up was 2 years. In the intention-to-treat population, the incidence rate (IR) of persistent qHPV (HPV6/11/16/18) was 2.3 per 100 person-years (/100PY) (95% confidence interval [CI], 1.1-4.1), and IR of genital warts was 2.3/100PY (95% CI, 1.2-4.1). In the per-protocol efficacy population, IR of persistent qHPV was 1.0/100PY (95% CI, 0.3-2.6) and of genital warts was 1.0/100PY (95% CI, 0.3-2.5). No cases of CIN2+ occurred. Reported rates of qHPV-related infection and disease within vaccinated women without HIV, unvaccinated women without HIV, and vaccinated WLWH: 0.1 (95% CI, 0.02-0.03), 1.5 (95% CI, 1.1-2.0), and 1.2 (95% CI, 0.2-3.4) /100PY, respectively. The rate of persistent qHPV among vaccinated WLWH was lower than among unvaccinated WLWH (2.3 vs 6.0/100PY). CONCLUSIONS: Vaccinated WLWH may be at higher risk for vaccine failure than vaccinated women without HIV. However, overall rates of vaccine failure were low, and rates of persistent qHPV were lower than in unvaccinated WLWH.
BACKGROUND:Human papillomavirus (HPV) vaccination is safe and efficacious in women without human immunodeficiency virus (HIV). Although good immunogenicity has been observed in women living with HIV (WLWH), efficacy data in this population are needed. METHODS: We enrolled 420 females aged ≥9 years (range, 9-65) living with HIV. Participants were to receive 3 doses of qHPV vaccine (0/2/6 months). The main endpoint was vaccine failure (ie, incident persistent qHPV infection, cervical intraepithelial neoplasia of grade 2 or higher [CIN2+], or genital warts). We compared these rates to published rates in vaccinated and unvaccinated women without HIV as well as unvaccinated WLWH. RESULTS: Among 279 eligible women, median follow-up was 2 years. In the intention-to-treat population, the incidence rate (IR) of persistent qHPV (HPV6/11/16/18) was 2.3 per 100 person-years (/100PY) (95% confidence interval [CI], 1.1-4.1), and IR of genital warts was 2.3/100PY (95% CI, 1.2-4.1). In the per-protocol efficacy population, IR of persistent qHPV was 1.0/100PY (95% CI, 0.3-2.6) and of genital warts was 1.0/100PY (95% CI, 0.3-2.5). No cases of CIN2+ occurred. Reported rates of qHPV-related infection and disease within vaccinated women without HIV, unvaccinated women without HIV, and vaccinated WLWH: 0.1 (95% CI, 0.02-0.03), 1.5 (95% CI, 1.1-2.0), and 1.2 (95% CI, 0.2-3.4) /100PY, respectively. The rate of persistent qHPV among vaccinated WLWH was lower than among unvaccinated WLWH (2.3 vs 6.0/100PY). CONCLUSIONS: Vaccinated WLWH may be at higher risk for vaccine failure than vaccinated women without HIV. However, overall rates of vaccine failure were low, and rates of persistent qHPV were lower than in unvaccinated WLWH.
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Authors: Elisabeth McClymont; Arianne Y Albert; Christine Wang; Scott J Dos Santos; François Coutlée; Marette Lee; Sharon Walmsley; Nancy Lipsky; Mona Loutfy; Sylvie Trottier; Fiona Smaill; Marina B Klein; Mark H Yudin; Marianne Harris; Wendy Wobeser; Janet E Hill; Deborah M Money Journal: Int J STD AIDS Date: 2022-07-01 Impact factor: 1.456
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