HVTN 140/HPTN 101

Primary Sponsor Details

Secondary Sponsor Details

Kenya, South Africa, USA and Zimbabwe

Inclusion criteria

• Age of 18 through 50 years
• Access to a participating CRS and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit.
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• HIV-Related Criteria:
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
• Assessed by the clinic staff as being at “low risk” for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit

Exclusion criteria

• Weight < 35kg or > 115 kg
• Blood products received within 120 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 140/HPTN 101 PSRT
• Investigational research agents received within 30 days before first study product administration
• Intent to participate in another study of an investigational research agent or any other study that requires non-Network HIV antibody testing during the planned duration of the HVTN 140/HPTN 101 study
• Vaccines, Antibodies, and other Injections or Infusions
• HIV vaccine(s) received in a prior HIV vaccine trial. Volunteers who have received control/placebo in an HIV vaccine trial are not excludedHVTN 140/HPTN 101.
• SARS-CoV-2 vaccine(s) received within 7 days prior to HVTN 140/HPTN 101 enrollment or planned within 7 days after enrollment.
• Receipt of humanized or human mAbs, whether licensed or investigational.
• Previous receipt of mAbs VRC01, VRC01LS, VRC07-523LS, PGDM1400, PGT121, PGT121.414.LS.
• Immunosuppressive medications received within 30 days before first study product administration (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatological condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 20 mg/day and length of therapy < 14 days)
• Serious adverse reactions to PGDM1400LS, VRC07-523LS, or PGT121.414.LS formulation components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
• Immunoglobulin received within 60 days before first study product administration (for mAb see criterion 8 above

Early discontinuation of administration and reason(s) for discontinuation and early study termination

Local and systemic Solicited AEs, laboratory measures of safety, Unsolicited AEs, and SAEs

9.0 DESIGN OF THE TRIAL

If controlled