DataSpace

Protocol C

Epidemiological studies of people who are in the early, acute stages of HIV infection are a high-value resource for vaccine design and development, as well as for cure research. In the Protocol C project launched in 2006, IAVI and a wide range of research partners study volunteers in Kenya, Uganda, Rwanda, Zambia and South Africa to learn more about how HIV progresses and is transmitted. More than 600 volunteers with incident HIV infection have enrolled in Protocol C to date. All volunteers are provided with or referred for routine HIV care, including ART provision. Some 190,000 Protocol C samples have been collected and more than 26,000 shared with researchers around the world.

Type: Prospective cohort

Study Status: Closed

Enrollment Status: Closed

Countries: Kenya, Uganda, Rwanda, Zambia, South Africa

Partners: Kenya AIDS Vaccine Initiative-Kangemi (KAVI-Kangemi), Nairobi;Kenya AIDS Vaccine Initiative-Kenyatta National Hospital (KAVI-KNH), Nairobi;Kenya Medical Research Institute-Centre for Geographic Medicine Research-Coast (KEMRI-CGMRC), Kilifi;Medical Research Council (MRC-Entebbe), Entebbe, Uganda;Medical Research Council (MRC-Masaka), Masaka, Uganda;Uganda Virus Research Institute-International AIDS Vaccine Initiative (UVRI-IAVI), Entebbe, Uganda;Projet San Francisco (PSF-Kigali), Kigali, Rwanda; Zambia-Emory Research Project (ZEHRP), Kitwe, Zambia;Zambia-Emory Research Project (ZEHRP), Ndola, Zambia;Zambia-Emory Research Project (ZEHRP), Lusaka, Zambia;Aurum Institute, Rustenburg, South Africa;Desmond Tutu HIV Foundation (DTHF), Cape Town, South Africa

Study Summary
To evaluate clinical, laboratory, immunologic and viral markers of disease progression in volunteers with recent HIV infection to prepare for activities relevant to the execution of preventive HIV vaccine efficacy trials. If identifiable and willing, HIV-infected partner(s) of enrolled volunteers will be assessed for virologic and immunogenetic parameters relevant to transmission.

Protocol G

In 2006, IAVI and its Neutralizing Antibody Consortium launched the Protocol G project to search for bNAbs against HIV, partnering with clinical research centers in Africa, India, Thailand, Australia, the United Kingdom, and the United States. More than 1,800 healthy, HIV-positive volunteers contributed blood samples to be screened. In 2009, scientists from IAVI, The Scripps Research Institute, and Theraclone Sciences collaborated to isolate and characterize the first new bNAbs to HIV seen in a decade and the first to be isolated from donors in developing countries, where the majority of new HIV infections occur. To date, more than 25 new bNAbs have been isolated and characterized from Protocol G specimens, and many have been shared with researchers across the AIDS vaccine field.

Type: Prevalence / cross-sectional

Study Status: Closed

Enrollment Status: Closed

Countries: Australia, India, Ivory Coast, Kenya, Nigeria, Rwanda, South Africa, Thailand, Uganda, United Kingdom, United States, Zambia

Partners: Uganda Virus Research Institute-International AIDS Vaccine Initiative (UVRI-IAVI), Entebbe, Uganda;Zambia-Emory Research Project (ZEHRP), Lusaka, Zambia;Projet San Francisco (PSF-Kigali), Kigali, Rwanda;Kenya AIDS Vaccine Initiative-Kenyatta National Hospital (KAVI-KNH), Nairobi, Kenya;YRG Care, Chennai, India;Vaccine Trial Centre, Mahidol University, Bangkok, Thailand;Centre de Diagnostic et de Recherche sur le SIDA et les infections opportunistes (CeDReS), CHU Treichville, Abidjan, Côte d’Ivoire;Institute of Human Virology (IHV), Nigeria;National Serology Reference Laboratory (NRL), Australia;St. Stephen’s Centre, London, UK;SUNY Downstate Medical Center, New York, USA;AFRIMS (Armed Forces Research Institute of Medical Sciences), Bangkok, Thailand.

Study Summary
To generate broadly neutralizing monoclonal antibodies (mAbs) from volunteers who are HIV infected and have broadly cross-reactive serum neutralizing activity.

Protocol N

Type: Prospective cohort

Study Status: Variable

Enrollment Status: Variable

Countries: Kenya; Uganda; Zambia; Rwanda; South Africa

Partners: HIV Pathogenesis Program (HPP); Kenya Medical Research Institute-Centre for Geographic Medicine Research-Coast (KEMRI-CGMRC), Kilifi, Kenya; Medical Research Council (MRC-Masaka)-Masaka, Uganda; Projet San Francisco (PSF); Zambia Emory HIV Research Project (ZEHRP)

Study Summary
Prospective cohort studies of volunteers identified prior to, or during antibody seroconversion, using real-time PCR on the GeneXpert platform, or overnight traditional PCR. Dozens of volunteers identified during this acute phase of HIV infection have been offered treatment, and are followed over time. Studies in Zambia, Kenya and South Africa are active. Studies in Rwanda are complete. Studies in Uganda are in development.