Quadrivalent HPV vaccine in HIV-1-infected early adolescent girls and boys in Kenya: Month 7 and 12 post vaccine immunogenicity and correlation with immune status |
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| Institution: | 1. Kenya Medical Research Institute, Center for Clinical Research, Kenya;2. Department of Global Health, University of Washington, Seattle, WA, USA;3. Partners in Health Research and Development, Kenya;4. Department of Obstetrics and Gynaecology, University of Washington, WA, USA;5. Department of Laboratory Medicine, University of Washington, Seattle, WA, USA;6. Department of Biostatistics, University of Washington, Seattle, WA, USA;7. Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA;8. Jomo Kenyatta University of Agriculture and Technology, Kenya;9. Departments of Medicine, University of Washington, Seattle, WA, USA;10. Department of Epidemiology, University of Washington, Seattle, WA, USA;11. Fred Hutchinson Cancer Research Center, Seattle, WA, USA;12. University of Nairobi, Kenya;1. Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden;2. Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark;3. European Molecular Biology Laboratory, Heidelberg, Germany;4. German Cancer Research Center, Heidelberg, Germany;5. Molecular Pathology Laboratory, Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark;6. Department of Laboratory Medicine, Lund University, Malmö, Sweden;1. Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi 110029, India;2. Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital, Barshi District, Solapur, Maharashtra 413401, India;3. Jehangir Clinical Development Centre, Jehangir Hospital Premises, Pune 411001, India;4. Christian Fellowship Community Health Centre, Ambillikai (near Oddanchathram), Dindigul District, Tamil Nadu 624612, India;5. MNJ Institute of Oncology & Regional Cancer Center, Red Hills, Lakadikapul, Hyderabad, Andhra Pradesh 500004, India;6. Gujarat Cancer & Research Institute (GCRI), M.P. Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad 380016, India;7. Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Sikkim 737101, Sikkim, India;8. Civil Hospital, Aizawl 796001, Mizoram, India;9. Department of Preventive Oncology, Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst, Parel, Mumbai 400012, India;10. Rajiv Gandhi Centre for Biotechnology, Poojappura, Thiruvananthapuram, 695014 Kerala, India;11. Screening Group, Section of Early Detection and Prevention, International Agency for Research on Cancer, 50 cours Albert Thomas, 69372 Lyon Cedex 08, France;12. Infection, inflammation and Cancer Program, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 242, D-69120 Heidelberg, Germany;13. Section of Infections and Cancer Biology, International Agency for Research on Cancer, Lyon, France;14. Cancer Foundation of India, Kolkata, West Bengal 700039, India;15. EMBL-DKFZ Chemical Biology Core Facility, European Molecular Biology Laboratory, D-69117 Heidelberg, Germany;1. School of Public Health and Community Medicine, Faculty of Medicine, University of New South Wales, Kensington, NSW 2052, Australia;2. Dept Gastroenterology Children’s Hospital at Westmead, Hawkesbury Rd, Westmead NSW 2145, Australia;3. Nephrology, Sydney Children’s Hospital, Randwick, High St, Randwick NSW 2031, Australia;4. School of Women’s & Children’s Health, Faculty of Medicine, University of New South Wales, Kensington, NSW 2052, Australia;5. The Women’s and Children’s Hospital and Robinson Research Institute and School of Medicine, The University of Adelaide, 55 King William Road, North Adelaide 5006, Australia;6. College of Public Service and Community Solutions, Arizona State University, USA;1. Clinical Vaccine Unit and Primary Care Research Consortium, Duke University School of Medicine, 2608 Erwin Road Suite 210, Durham, NC 27705, USA;2. Division of STD Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30329-4027, USA;3. Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30329-4027, USA;1. Centro de Investigación en Salud Poblacional, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, Mexico;2. University of Cambridge, Cambridge, United Kingdom;3. National Cancer Institute of Colombia, Bogotá, Colombia;4. Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Cuernavaca, Morelos, Mexico;5. International Agency for Research on Cancer, Lyon, France |
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| Abstract: | IntroductionIn sub-Saharan Africa, a generation of HIV-1-infected children is approaching the age of sexual debut and becoming at risk for HPV infection and its sequelae. We assessed safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in HIV-1-infected adolescents.MethodsIn an open-label trial among Kenyan, HIV-1-infected adolescents aged 9–14 years, we administered the qHPV vaccine at 0, 2 and 6 months and measured antibody titers to HPV-16, 18, 6 and 11 at month 7 and 12 post-vaccination. Measures of immunogenic response from HIV-1-negative historical cohorts from Africa and HIV-1 positive adolescent cohorts from the USA were used for comparison.ResultsWe enrolled 100 girls and 80 boys with a median age of 12 years and median baseline CD4 cell count of 684 (IQR 478, 935) cells/µL. One hundred and fifty four (86%) were receiving antiretroviral therapy for a median of 4.5 (IQR 2.3, 6.3) years; 110 (71%) had <400 copies of plasma HIV-1 RNA/mL. Of 189 enrolled children, 179 received all three doses. Two hundred and eighty five (64%) of 445 adverse events were injection site reactions; none were greater than grade 2. Of 6 Serious Adverse Events (SAEs), none were considered vaccine related. Seroconversion to HPV-18, 16, 11, 6 at month 7 occurred in 93.3%, 98.3%, 97.2% and 99.6% of vaccine recipients; similar rates have been reported in historical controls. The mean log10 HPV antibody titer measured at month 7 increased with each log10 increase in CD4 by 1.4 (95% CI: 1.1–1.7) for HPV-18; 1.2 (0.9–1.4) for HPV-16; 1.1 (0.8–1.3) for HPV-11; 0.7 (0.5–1.0) for HPV-6 (all p < 0.0001).ConclusionAlmost all Kenyan HIV-1-infected adolescents mounted an immune response comparable to other immunized populations. HPV antibody titers were higher in those with preserved CD4 cell counts. Longer term-follow up will determine sustainability of the immune response.ClinicalTrials.gov number, NCT00557245. |
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| Keywords: | Quadrivalent HPV vaccine HIV-1 Sub-Saharan Africa Immunogenicity Safety Adolescents |
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