Trial Outcomes & Findings for Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons (NCT NCT03803605)

Last Updated: 2021-12-02

Results Overview

The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 3 is defined as severe and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs assessments are considered related to study product as possible, probable, or definite as defined in the protocol.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

First day of study treatment through end of study, a total of approximately 36 weeks

Results posted on

2021-12-02

Participant Flow

Participants meeting the following advancement criteria in Step 1: a frequency of resting CD4+ T cell infection (RCI) \>0.30 per million cells proceeded to Step 2 and received the study intervention.

Participant milestones

Participant milestones
Measure	VRC07-523LS + Vorinostat (VOR) Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered) Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)
Overall Study STARTED	15
Overall Study Step 1: Participants With an RCI Measurement > 0.30 Per Million Cells	8
Overall Study Steps 2-4: Participants Receiving Study Intervention	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VRC07-523LS + Vorinostat (VOR) n=15 Participants Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered) Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: First day of study treatment through end of study, a total of approximately 36 weeks

Outcome measures

Outcome measures
Measure	VRC07-523LS + Vorinostat (VOR) n=8 Participants Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered) Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)
Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE)	0 percentage of participants

Adverse Events

All Enrolled Participants Completing Step 1 (Visits 1 and 2)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Participants Receiving VRC07-523LS + Vorinostat (VOR) (Step 2/Visits 3-13)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Cynthia Gay, MD, MPH

University of North Carolina at Chapel Hill

Phone: 919-966-2537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	All Enrolled Participants Completing Step 1 (Visits 1 and 2) n=15 participants at risk Participants meeting enrollment criteria who completed a Baseline leukapheresis procedure.	Participants Receiving VRC07-523LS + Vorinostat (VOR) (Step 2/Visits 3-13) n=8 participants at risk Participants with a Baseline RCI \> 0.30 per million cells who received two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. VRC07-523LS: VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered) Vorinostat (VOR): Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)
Injury, poisoning and procedural complications Procedural hypertension	86.7% 13/15 • Number of events 14 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	87.5% 7/8 • Number of events 7 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
General disorders Tissue infiltration	20.0% 3/15 • Number of events 4 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	0.00% 0/8 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
General disorders Vessel puncture site bruise	6.7% 1/15 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	0.00% 0/8 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
General disorders Vessel puncture site swelling	6.7% 1/15 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	0.00% 0/8 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Gastrointestinal disorders Diarrhea	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Gastrointestinal disorders Nausea	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
General disorders Fatigue	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	37.5% 3/8 • Number of events 4 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
General disorders Injection site pain	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Investigations Blood HIV RNA increased	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Investigations Blood pressure systolic increased	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	25.0% 2/8 • Number of events 2 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Investigations Glomerular filtration rate decreased	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Musculoskeletal and connective tissue disorders Athralgia	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Nervous system disorders Headache	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 6 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.
Skin and subcutaneous tissue disorders Skin discoloration	0.00% 0/15 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.	12.5% 1/8 • Number of events 1 • For all participants (n=15): from the signing of informed consent through completion of Baseline leukapheresis (Visit 2), approximately 10 weeks. For qualifying participants who advanced to Step 2 (n=8) and initiated treatment (Visit 3) through end of study (Visit 13) an additional 26 weeks. A combined overall total of 36 weeks for intervention-treated participants. Solicited adverse events were collected using diaries for 72 hours following each infusion of VRC07-523LS. For reactogenicity assessment, participants recorded local and systemic pre-defined adverse events. Unsolicited adverse events were actively assessed by study staff at each intervention.