The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies

Inclusion criteria

• ✓. Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): Volunteer demonstrates an understanding of this study and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly.
• ✓. 18 to 55 years old, inclusive, on day of enrollment.
• ✓. Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening.
• ✓. On suppressive ART for at least 48 weeks prior to screening. ART is defined as a combination therapy regimen including at least 1 integrase inhibitor and 1 nucleoside reverse transcriptase inhibitor (such as Dovato™) or 2 nucleoside reverse transcriptase inhibitors plus integrase inhibitors. Changes in ARVs for reasons other than virologic failure (eg, tolerability, simplification, different formulation, drug-drug interaction profile) are allowed within 48 weeks prior to screening and up until 6 weeks prior to screening. A fully active alternative ARV regimen is available, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance.
• ✓. Plasma HIV RNA \< 50 copies/mL (or lower limit of quantitation \[LLOQ\]) for at least 48 weeks prior to enrollment. NOTE: At least one viral load measurement within 48 weeks prior to the screening visit and another viral load from the screening prior to enrollment visit must be available for review. Two "blips" (ie, plasma HIV-1 RNA \> LLOQ and \< 400 copies/mL) are allowed if each blip is preceded and followed by values \< LLOQ and if the blip(s) occur(s) more than 24 weeks prior to enrollment.
• ✓. CD4+ cell count \> 450 cells/mm3 and CD4+ cell % ≥ 15% obtained within 40 days prior to enrollment.
• ✓. Available for clinic follow-up through the last clinic visit, willing to undergo leukapheresis, and willing to be contacted 12 months after the last study-product administration.