Cohort Profile: IAVI's HIV epidemiology and early infection cohort studies in Africa to support vaccine discovery

• Type of Material: Article
• Authors: Matt A Price, IAVI, New York, USA & Nairobi, Kenya; William Kilembe, Rwanda Zambia Emory HIV Research Group; Eugene Ruzagira, Medical Research Council, Uganda; Etienne Karita, Rwanda Zambia Emory HIV Research Group; Mubiana Inambao, Rwanda Zambia Emory HIV Research Group; Eduard J Sanders, Kenyan Medical Research Institute-Wellcome Trust; Omu Anzala, KAVI-Institute of Clinical Research, Nairobi; Susan Allen, Emory University; Vinodh A Edward, The Aurum Institute, South Africa; Pontiano Kaleebu, Medical Research Council, Uganda; Patricia E Fast, IAVI, New York, USA & Nairobi, Kenya; Wasima Rida, Biostatistics Consultant, Arlington; Anatoli Kamali, IAVI, New York, USA & Nairobi, Kenya; Eric Hunter, Emory University; Jianming Tang, University of Alabama Birmingham; Shabir Lakhi, Rwanda Zambia Emory HIV Research Group; Gaudensia Mutua, KAVI-Institute of Clinical Research, Nairobi; Linda Gail Bekker, University of Cape Town; Ggayi Abu-Baker, Medical Research Council, Uganda; Amanda Tichacek, Rwanda Zambia Emory HIV Research Group; Paramesh Chetty, IAVI, New York, USA & Nairobi, Kenya; Mary H Latka, The Aurum Institute, South Africa; Pholo Maenetje, The Aurum Institute, South Africa; Heeran Makkan, The Aurum Institute, South Africa; Jonathan Hare, IAVI Human Immunology Laboratory, UK; Freddie Kibengo, Medical Research Council, Uganda; Fran Priddy, IAVI, New York, USA & Nairobi, Kenya; Elise Landais, IAVI, New York, USA & Nairobi, Kenya; Kundai Chinyenze, IAVI, New York, USA & Nairobi, Kenya; Jill Gilmour, IAVI Human Immunology Laboratory
• Language: English
• Date: 2021-02-01
• Publisher: OXFORD UNIV PRESS
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2020.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1093/ije/dyaa100
• Title of Journal or Parent Work: INTERNATIONAL JOURNAL OF EPIDEMIOLOGY
• Volume: 50
• Issue: 1
• Start Page: 29
• End Page: +
• Grant/Funding Information: This work (i.e. Protocol B, HT Study and Protocol C) was supported by the United States Agency for International Development (USAID). The following grants also supported the HT Study in Rwanda and Zambia: NIH-NIAID P30 AI050409, NIH-FIC TW001042, NIH-NIAID R01 AI040951, NIH-NIMH R01 MH066767, NIH-NICHD R01 HD040125, NIH-NIAID R01 AI064060, and NIH-NIAID R37 AI51231. Some of the Early HIV Infection Cohort (Protocol C) work done at Emory was supported by the Yerkes National Primate Research Center base grant through the Office of Research Infrastructure Programs (OD P51OD11132). HIV neutralizing antibody work was funded in part by the National Institute Of Allergy And Infectious Diseases (grant number U19AI090970) as well as Bill and Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery grants numbered OPP1084519 (2013–2018), OPP1196345 (2019–2021) and OPP1115782 (2015–2019).
• Keywords: Public, Environmental & Occupational Health; Science & Technology; Life Sciences & Biomedicine
• Research Categories: Health Sciences, Immunology; Health Sciences, Epidemiology; Biology, Biostatistics

Abstract

In 2003, IAVI (formerly the International AIDS Vaccine Initiative) identified several gaps in HIV epidemiology and vaccine research. IAVI launched cohort studies to better understand at-risk populations, their suitability for clinical trial participation and their unmet needs for preventive services and products. Our goals included (i) improving our understanding of HIV incidence and volunteer retention among ‘key populations’ of at-risk persons suitable for participation in large-scale HIV prevention trials; (ii) identifying and addressing unmet needs for health care, counselling and prevention among these key populations; (iii) understanding host–virus interactions both shortly after virus acquisition and longer term; (iv) generating data and reagents from recently transmitted HIV to support new vaccine product discovery; and (v) understanding clinical outcomes of HIV disease in the African context to define clinical trial endpoints where antiretroviral therapy (ART) was not (yet) widely available, while building the clinical, laboratory and quality systems to support future trials. To this end, starting in 2004, IAVI established partnerships with nine experienced clinical research centres in east and southern Africa to enrol suitable volunteers (Figure 1). This manuscript includes data from two broad protocols that followed persons at risk of HIV acquisition (1) ‘A prospective, open cohort, observational feasibility study to determine HIV incidence in preparation for future preventive HIV vaccine clinical trials’ (IAVI Protocol B) and (2) ‘Heterosexual transmission of HIV in Africa’ [Emory Heterosexual Transmission (HT) study]. Between 2005 and 2009, varying by research centre, through to December 2011, they served as the source populations for a third cohort study on the natural history of HIV infection, ‘A prospective, observational, multi-center study to evaluate laboratory, clinical, immunologic and viral markers of disease progression in recently HIV-infected volunteers’ (IAVI Protocol C). Table 1 summarizes the start and stop dates for each site and each cohort. As part of participating in each respective cohort study, clinical and laboratory teams were trained in good clinical practices and good clinical laboratory practices, laboratories were accredited, and all assays were standardized and conducted under an external quality control programme.1 Study teams met annually, typically in Africa, to share experiences and results and for additional training.