Health Trials

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

ConditionHIV
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together.

Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B).

Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits.

Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 to 55 years.

Can visit a participating clinic and is willing to stay in the study for its full duration.

Understands the study and is able and willing to give informed consent.

Agrees not to join another experimental study until the final required clinic visit.

Disqualifiers

Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment).

Took any experimental (investigational) research drug within 30 days before the first study dose.

Weighs less than 35 kg or more than 115 kg.

Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ePGT121v1-LS (IV)

    Biological/Vaccine

    Intravenous infusion (IV)

  • PGDM1400LS (IV)

    Biological/Vaccine

    IV infusion

  • VRC07-523LS (IV)

    Biological/Vaccine

    IV infusion

  • ePGT121v1-LS (SC)

    Biological/Vaccine

    Subcutaneous (SC) injection

  • PGDM1400LS (SC)

    Biological/Vaccine

    SC injection

  • VRC07-523LS (SC)

    Biological/Vaccine

    SC injection

Treatment groups

83 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A: Group 1Experimental treatment 1 intervention
Group B: Part A: Group 2Experimental treatment 1 intervention
Group C: Part A: Group 3Experimental treatment 1 intervention
Group D: Part A: Group 4Experimental treatment 3 interventions
Group E: Part A: Group 5Experimental treatment 3 interventions
Group F: Part A: Group 6Experimental treatment 3 interventions
Group G: Part B: Group 7Experimental treatment 1 intervention
Group H: Part B: Group 8Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part A: Number of participants with solicited local Adverse Events (AEs)

Time frame
Baseline through Week 48
2

Part B: Number of participants with solicited local Adverse Events (AEs)

Time frame
Baseline through Week 24
3

Part A: Percentage of participants with solicited local Adverse Events (AEs)

Time frame
Baseline through Week 48
4

Part B: Percentage of participants with solicited local Adverse Events (AEs)

Time frame
Baseline through Week 24

Secondary outcomes

1

Serum Concentration of ePGT121v1-LS

Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

Time frame
Baseline through Week 48
2

Serum Concentration of PGDM1400LS

Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

Time frame
Baseline through Week 48
3

Serum Concentration of VRC07-523LS

Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

Time frame
Baseline through Week 48
4

Correlation Between Serum/Plasma Concentration and Serum Neutralization Titer (ID50) for Each Virus

All participants in all groups regardless of how many product administrations and how much product they received

Time frame
Baseline through Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Department of Health and Human Services

Collaborator

Source ClinicalTrials.gov
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