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Original article
Inflammatory cytokine biomarkers of asymptomatic sexually transmitted infections and vaginal dysbiosis: a multicentre validation study
  1. Lindi Masson1,2,
  2. Shaun Barnabas1,3,
  3. Jennifer Deese4,5,
  4. Katie Lennard1,
  5. Smritee Dabee1,
  6. Hoyam Gamieldien1,
  7. Shameem Z Jaumdally1,
  8. Anna-Lise Williamson1,
  9. Francesca Little6,
  10. Lut Van Damme7,
  11. Khatija Ahmed8,
  12. Tania Crucitti9,
  13. Saïd Abdellati9,
  14. Linda-Gail Bekker1,3,
  15. Glenda Gray10,11,
  16. Janan Dietrich10,
  17. Heather Jaspan1,12,
  18. Jo-Ann S Passmore1,2,13
  1. 1 Institute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa
  2. 2 Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa
  3. 3 Desmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa
  4. 4 Contraceptive Technology and Innovation Department, Family Health International 360, Durham, North Carolina, USA
  5. 5 Department of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  6. 6 Department of Statistical Sciences, University of Cape Town, Cape Town, South Africa
  7. 7 The Bill & Melinda Gates Foundation, Seattle, Washington, USA
  8. 8 Setshaba Research Centre, Pretoria, South Africa
  9. 9 Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
  10. 10 Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa
  11. 11 South African Medical Research Council, Cape Town, South Africa
  12. 12 Seattle Children’s Research Institute, University of Washington, Seattle, Washington, USA
  13. 13 National Health Laboratory Service, Johannesburg, South Africa
  1. Correspondence to Dr Lindi Masson, Institute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa ; L.Masson{at}uct.ac.za

Footnotes

  • LM and SB contributed equally.

  • Handling editor Jackie A Cassell

  • Contributors LM conceptualised the study, generated some of the data, analysed the data and wrote the manuscript. SB managed the WISH cohort, generated and analysed some of the data and wrote the manuscript. JD, KL and SA generated and analysed some of the data and contributed to manuscript preparation. SD assisted with the management of the WISH cohort, processed clinical samples, generated some of the data and contributed to manuscript preparation. HG and SZJ assisted with the management of the WISH cohort, processed the clinical samples and contributed to manuscript preparation. ALW, TC and HJ supervised the acquisition and analysis of some of the data and contributed to manuscript preparation. FL analysed the data and contributed to manuscript preparation. LVD and KA managed the FEM-PrEP trial, collected clinical data and contributed to manuscript preparation. LGB, GG and JD managed the clinical sites for the WISH study, collected some of the clinical data and contributed to manuscript preparation. JASP conceptualised the study, managed the WISH cohort, supervised the acquisition and analysis of some of the data and contributed to manuscript preparation.

  • Funding This work was supported by a Strategic Health Innovation Partnerships (SHIP) grant from the South African Medical Research Council (MRC; http://ship.mrc.ac.za) and grants from the Poliomyelitis Research Foundation (PRF; http://www.prf.ac.za) of South Africa and European and Developing Countries Clinical Trials Partnership (EDCTP; http://www.edctp.org). FEM-PrEP was conducted under two grants funded by the US Agency for International Development (USAID; https://www.usaid.gov): the Contraceptive and Reproductive Health Technologies and Research Utilization Program (GPO-A-00-05- 00022-00) and the Preventive Technologies Agreement (GHO-A-00-09-00016-00). Early support was also provided by the Bill & Melinda Gates Foundation (https://www.gatesfoundation.org). LM was supported by the National Research Foundation (NRF) of South Africa (http://www.nrf.ac.za), the UCT Clinical Infectious Diseases Research Initiative/Wellcome Trust (http://www.cidri.uct.ac.za) and the MRC.

  • Competing interests JASP and LM, together with the University of Cape Town, have submitted a Patent application for IP-10 and IL-1α/β use for diagnosing an inflammatory condition in the female genital tract likely caused by an STI or BV.

  • Patient consent Not required.

  • Ethics approval The University of Witwatersrand (M1307) and the University of Cape Town (267/2013) Human Research Ethics Committees and the FHI 360 Protection of Human Subjects Committee (10015) approved this study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The data sets used and/or analysed during this study are available from the corresponding author on reasonable request.

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Footnotes

  • LM and SB contributed equally.

  • Handling editor Jackie A Cassell

  • Contributors LM conceptualised the study, generated some of the data, analysed the data and wrote the manuscript. SB managed the WISH cohort, generated and analysed some of the data and wrote the manuscript. JD, KL and SA generated and analysed some of the data and contributed to manuscript preparation. SD assisted with the management of the WISH cohort, processed clinical samples, generated some of the data and contributed to manuscript preparation. HG and SZJ assisted with the management of the WISH cohort, processed the clinical samples and contributed to manuscript preparation. ALW, TC and HJ supervised the acquisition and analysis of some of the data and contributed to manuscript preparation. FL analysed the data and contributed to manuscript preparation. LVD and KA managed the FEM-PrEP trial, collected clinical data and contributed to manuscript preparation. LGB, GG and JD managed the clinical sites for the WISH study, collected some of the clinical data and contributed to manuscript preparation. JASP conceptualised the study, managed the WISH cohort, supervised the acquisition and analysis of some of the data and contributed to manuscript preparation.

  • Funding This work was supported by a Strategic Health Innovation Partnerships (SHIP) grant from the South African Medical Research Council (MRC; http://ship.mrc.ac.za) and grants from the Poliomyelitis Research Foundation (PRF; http://www.prf.ac.za) of South Africa and European and Developing Countries Clinical Trials Partnership (EDCTP; http://www.edctp.org). FEM-PrEP was conducted under two grants funded by the US Agency for International Development (USAID; https://www.usaid.gov): the Contraceptive and Reproductive Health Technologies and Research Utilization Program (GPO-A-00-05- 00022-00) and the Preventive Technologies Agreement (GHO-A-00-09-00016-00). Early support was also provided by the Bill & Melinda Gates Foundation (https://www.gatesfoundation.org). LM was supported by the National Research Foundation (NRF) of South Africa (http://www.nrf.ac.za), the UCT Clinical Infectious Diseases Research Initiative/Wellcome Trust (http://www.cidri.uct.ac.za) and the MRC.

  • Competing interests JASP and LM, together with the University of Cape Town, have submitted a Patent application for IP-10 and IL-1α/β use for diagnosing an inflammatory condition in the female genital tract likely caused by an STI or BV.

  • Patient consent Not required.

  • Ethics approval The University of Witwatersrand (M1307) and the University of Cape Town (267/2013) Human Research Ethics Committees and the FHI 360 Protection of Human Subjects Committee (10015) approved this study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The data sets used and/or analysed during this study are available from the corresponding author on reasonable request.

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