Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial - Nature Medicine

) in group 2 were randomized at a ratio of three antibody recipients to one placebo recipient, respectively . At each dose level in part 1, IP administration was separated by at least 24 hours for each of the first three participants. Randomization in part 1 ensured that at least two participants received active product and were observed for at least 24 hours before administration to additional participants.

was formulated in a 20 mM acetate, 9% sucrose, 0.008% polysorbate 80, pH 5.2 formulation buffer at a concentration of 50 mg mlis a recombinant, fully human monoclonal antibody of the IgG1 isotype that binds to the HIV envelope. PGT121 was formulated in a 20 mM acetate, 9% sucrose, 0.008% polysorbate 80, pH 5.2 formulation buffer at a concentration of 50 mg mlis a recombinant, fully human monoclonal antibody of the IgG1 isotype that binds to the HIV envelope.

, PGT121 and VRC07-523LS serum levels, HIV sequencing and immunogenicity, among other research assessments outlined in the Study Protocol .Participants with HIV who were not on ART received ART counseling upon entering the study and 8 weeks after administration of the IP. Participants who had not initiated or made plans to initiate ART by the final study visit received ART counseling again at their final study visit.

and VRC07-523LS levels were determined on a Bio-Plex 200 system that measures the ability of each monoclonal antibody to bind to their specific anti-idiotype antibody captured on fluorescent magnetic microspheres , using a customized and standardized HIV-1 assay

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