Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial.

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Title: Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial.
Authors: Mahomed S; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa Sharana.Mahomed@caprisa.org., Garrett N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa., Karim QA; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Epidemiology, Mailman School of Public Health, Columba University, New York, New York, USA., Zuma NY; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Capparelli E; University of California San Diego, San Diego, California, USA., Baxter C; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Gengiah T; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Archary D; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Samsunder N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa., Doria-Rose N; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Moore P; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa., Williamson C; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Health Laboratory Services of South Africa, Johannesburg, South Africa.; Division of Medical Virology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Barouch DH; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Fast PE; International Aids Vaccine Initiative, New York, New York, USA., Pozzetto B; GIMAP (EA3064), University of Saint-Etienne/University of Lyon, Saint-Etienne, France., Hankins C; Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands., Carlton K; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Ledgerwood J; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Morris L; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa., Mascola J; Vaccine Research Center, National Institutes of Health, Bethesda, Maryland, USA., Abdool Karim S; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.; Department of Epidemiology, Mailman School of Public Health, Columba University, New York, New York, USA.
Source: BMJ open [BMJ Open] 2020 Nov 26; Vol. 10 (11), pp. e042247. Date of Electronic Publication: 2020 Nov 26.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't; Clinical Trial Protocol
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:2044-6055
DOI:10.1136/bmjopen-2020-042247