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Monoclonal Antibodies

VRC-HIVMAB091-00-AB for HIV (VRC 609 Trial)

Phase 1
Waitlist Available
Led By Martin R Gaudinski, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4 and 8 for single dose groups, or baseline and weeks 4, 28, and 32 for repeat dose groups
Awards & highlights

VRC 609 Trial Summary

This trial is testing a new human monoclonal antibody, N6LS, to see if it is safe in healthy adults. It will be given IV or SC, and blood samples will be collected to test how the product changes in the body over time. There are 14-26 clinic visits over 6-12 months.

VRC 609 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4 and 8 for single dose groups, or baseline and weeks 4, 28, and 32 for repeat dose groups
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 4 and 8 for single dose groups, or baseline and weeks 4, 28, and 32 for repeat dose groups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Number of Participants With Abnormal Laboratory Measures of Safety Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
+3 more
Secondary outcome measures
Number of Participants Who Produced N6LS Anti-drug Antibodies (ADA) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Pharmacokinetic (PK) Parameters of N6LS: Beta Half-life (T1/2b)
Pharmacokinetic (PK) Parameters of N6LS: Clearance Rate
+3 more

Side effects data

From 2022 Phase 1 trial • 33 Patients • NCT03538626
100%
Administration site erythema
40%
Administration site pain
20%
Aspartate aminotransferase increased
20%
Sebaceous cyst excision
20%
Administration site pruritus
20%
Administration site swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose
Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose
Group 1: N6LS (5 mg/kg IV) Single Dose
Group 2: N6LS (5 mg/kg SC) Single Dose
Group 3: N6LS (20 mg/kg IV) Single Dose
Group 4: N6LS (40 mg/kg IV) Single Dose
Group 5: N6LS (5 mg/kg SC) Repeat Dose
Group 6: N6LS (20 mg/kg IV) Repeat Dose

VRC 609 Trial Design

8Treatment groups
Experimental Treatment
Group I: Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) single doseExperimental Treatment2 Interventions
N6LS (20 mg/kg) + rHuPH20 (2000 U/ml) administered by SC injection (Day 0)
Group II: Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) single doseExperimental Treatment2 Interventions
N6LS (5 mg/kg) + rHuPH20 (2000 U/ml) administered by SC injection (Day 0)
Group III: Group 6: N6LS (20 mg/kg IV) repeat doseExperimental Treatment1 Intervention
N6LS (20 mg/kg) administered by IV infusion (Day 0, Week 12 and Week 24)
Group IV: Group 5: N6LS (5 mg/kg SC) repeat doseExperimental Treatment1 Intervention
N6LS (5 mg/kg) administered by SC injection (Day 0, Week 12 and Week 24)
Group V: Group 4: N6LS (40 mg/kg IV) single doseExperimental Treatment1 Intervention
N6LS (40 mg/kg) administered by IV infusion (Day 0)
Group VI: Group 3: N6LS (20 mg/kg IV) single doseExperimental Treatment1 Intervention
N6LS (20 mg/kg) administered by IV infusion (Day 0)
Group VII: Group 2: N6LS (5 mg/kg SC) single doseExperimental Treatment1 Intervention
N6LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
Group VIII: Group 1: N6LS (5 mg/kg IV) single doseExperimental Treatment1 Intervention
N6LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rHuPH20
2008
Completed Phase 2
~650
VRC-HIVMAB091-00-AB
2018
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,436 Total Patients Enrolled
Martin R Gaudinski, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
11 Previous Clinical Trials
7,786 Total Patients Enrolled
Richard L Wu, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
PLOS MedicineJournal
Safety and Pharmacokinetics of the Fc-modified HIV-1 Human Monoclonal Antibody VRC01LS: A Phase 1 Open-label Clinical Trial in Healthy Adults
Gaudinski, Martin R., Emily E. Coates, Katherine V. Houser, Grace L. Chen, Galina Yamshchikov, Jamie G. Saunders, LaSonji A. Holman, et al.. 2018. “Safety and Pharmacokinetics of the Fc-modified HIV-1 Human Monoclonal Antibody VRC01LS: A Phase 1 Open-label Clinical Trial in Healthy Adults”. Edited by Marcus Altfeld. PLOS Medicine. Public Library of Science (PLoS). doi:10.1371/journal.pmed.1002493.
ImmunityJournal
Identification of a Cd4-binding-site Antibody to HIV That Evolved Near-pan Neutralization Breadth
Huang, Jinghe, Byong H. Kang, Elise Ishida, Tongqing Zhou, Trevor Griesman, Zizhang Sheng, Fan Wu, et al.. 2016. “Identification of a Cd4-binding-site Antibody to HIV That Evolved Near-pan Neutralization Breadth”. Immunity. Elsevier BV. doi:10.1016/j.immuni.2016.10.027.
Clinical and Experimental ImmunologyJournal
Safety, Pharmacokinetics and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults
VRC 602 Study Team, J E Ledgerwood, E E Coates, G Yamshchikov, J G Saunders, L Holman, M E Enama, et al.. 2015. “Safety, Pharmacokinetics and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults”. Clinical and Experimental Immunology. Oxford University Press (OUP). doi:10.1111/cei.12692.
Clinical and Experimental ImmunologyJournal
Safety, Pharmacokinetics and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults
VRC 602 Study Team, J E Ledgerwood, E E Coates, G Yamshchikov, J G Saunders, L Holman, M E Enama, et al.. 2015. “Safety, Pharmacokinetics and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults”. Clinical and Experimental Immunology. Oxford University Press (OUP). doi:10.1111/cei.12692.
~5 spots leftby Apr 2025
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