A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

Exclusion Criteria29

• Participants cannot have had a blood transfusion within the last 120 days.
• Participants cannot have received experimental treatments within the last 30 days.
• Participants cannot weigh less than 35 kg (about 77 lbs).
• Participants cannot plan to join another clinical trial during this study.
• Participants cannot be pregnant or breastfeeding.
• Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval).
• Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days.
• Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago.
• Participants cannot have had allergy shots within the last 14 days.
• Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments.
• Participants cannot participate if they have had serious allergic reactions to the components of the study product.
• Participants cannot have received immunoglobulin within the last 60 days.
• Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable.
• Participants cannot have an immune system deficiency.
• Participants cannot have any significant medical condition or abnormal lab results that could impact their health during the study.
• Participants cannot have conditions that make repeated injections or blood draws difficult.
• Participants cannot have conditions requiring active medical treatment that could pose a risk during the study.
• Participants cannot have conditions that could be confused with reactions to the study product.
• Participants cannot have medical, social, or occupational conditions that would interfere with the study.
• Participants cannot have severe psychiatric conditions, like ongoing risk of suicide or recent history of suicide attempts.
• Participants cannot be undergoing treatment for tuberculosis.
• Participants cannot have severe asthma that requires frequent medication or emergency care.
• Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary).
• Participants blood pressure must be below 160/110 mmHg.
• Participants cannot have any diagnosed bleeding disorders.
• Participants cannot have active cancer but may be eligible if, in the investigator's estimation, they have a reasonable assurance of sustained cure, or are unlikely to experience recurrence of malignancy during the period of the study
• Participants cannot have had seizures or taken seizure medications in the past 3 years.
• Participants cannot have a history of severe allergic reactions like anaphylaxis, unless it has been well-controlled for at least 5 years.
• Participants cannot have acute or unstable hepatitis B or C, but stable chronic cases may be considered.