SAFETY AND VIROLOGIC EFFECT OF A HUMAN MONOCLONAL ANTIBODY, VRC-HIVMAB060-00-AB (VRC01), WITH BROAD HIV-1 NEUTRALIZING ACTIVITY, ADMINISTERED INTRAVENOUSLY TO ADULTS DURING EARLY ACUTE HIV INFECTION
This is a multi-center study conducted in three East African countries (Tanzania, Kenya, Uganda) and Thailand. The participants obtained from RV 217 cohort.The study product (VRC01) is a broadly neutralizing human mAb targeted against the HIV-1 CD4 binding site. It was developed by the VRC/NIAID/NIH. VRC01 is of the Immunoglobulin G1 (IgG1) subtype and is highly somatically mutated from its germ-line precursor. The heavy chain CDR3 region is 14 amino acids long, which is an average length relative to natural antibodies, and the glycosylation pattern is derived from its production in a Chinese Hamster Ovary (CHO) mammalian cell line.
National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS),
National Institutes of Health (NIH) Bethesda, Maryland