Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
Study Details
Study Description
Brief Summary
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies are in fact able to prevent (S)HIV infection in animal models and therefore of great interest for the development of an HIV vaccine. Information of neutralizing antibodies in patients from Africa is still scarce and would be of great value in the development of adapted HIV vaccine strategies in these regions. This study aims to investigate African HIV-infected individuals, who have developed neutralizing antibodies using highly specialized laboratory methodologies.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Broadly HIV-1 neutralizing antibodies (bNAb) [December 31, 2018]
identify HIV-infected patients which exhibit exceptional HIV-1 neutralizing activity (so called elite neutralizer) and to perform in those patients in depth characterization including: Detailed analysis of anti-HIV antibody response using single B cell analyis Isolation of broadly neutralizing anti-HIV antibodies Testing of in vitro neutralizing activity and binding properties of newly identified bNAbs Analysis of the antiviral activity and in vivo characteristics of broadly neutralizing antibodies using a HIV-1-infected humanized mouse model
Secondary Outcome Measures
- To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer [December 31, 2018]
- To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers [December 31, 2018]
- To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance) [December 31, 2018]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Voluntary and informed consent
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≥18 years of age
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Documented HIV infection.
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Willing to consent to active tracing including home tracing
Exclusion Criteria:
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Deficiency, rendering it difficult, if not impossible, to take part in the study or understand the information provided. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
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Prisoners
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If within the discretion of the investigator study participation would possibly add not acceptable risk or burden to patient (e.g. significant health deficiencies, social harm)
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Unlikely to comply with protocol as judged by the principal investigator or his designate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NIMR-Mbeya Medical Research Center (MMRC) | Mbeya | Tanzania |
Sponsors and Collaborators
- Michael Hoelscher
- National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC)
- University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC)
- Max von Pettenkofer-Institute of the University of Munich (LMU), Department of Virology
Investigators
- Study Chair: Arne Kroidl, Dr., Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, Germany
- Principal Investigator: Wiston William, Dr., NIMR-Mbeya Medical Research Center (MMRC), Tazania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LMU-IMPH-bNAb