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Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults

NCT02599896 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses. Researchers want to see if it does this in people.

Objectives:

To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is maintained in people and if they develop an immune response to it.

Eligibility:

Healthy people ages 18 to 50

Design:

Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical history, physical exam, and blood and urine tests.

The study will last 24 to 48 weeks. Visits will last 2 to 8 hours.

Participants will get VRC01LS through either:

* A needle in an arm vein or
* A small needle placed into the fatty tissue under the skin of the abdomen, thigh, or arm.

Participants will be assigned to 1 of 6 groups.

Groups 1 to 4 will get 1 dose of VRC01LS. They will have follow-up visits through week 24.

Groups 5 and 6 will get 1 dose of VRC01LS every 12 weeks (3 doses). They will have 4 to 5 visits between the second and third dose, and follow-up visits through week 48.

Participants will have 1 to 3 follow-up visits in the week after receiving VRC01LS. They will record their temperature and keep a diary of symptoms for 3 days after a dose. They may have additional unscheduled visits.

At each visit, participants will have a physical exam and may have blood and urine tests.

Conditions

  • Prevention of HIV Infection
  • HIV Antibodies
  • Monoclonal Antibody, Human
  • Neutralizing Antibody

Interventions

BIOLOGICAL

VRC-HIVMAB080-00-AB (VRC01LS)

VRC01LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

BIOLOGICAL

VRC-HIVMAB060-00-AB (VRC01)

VRC01 is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Martin R Gaudinski, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-16
Primary Completion
2018-07-25
Completion
2018-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599896 on ClinicalTrials.gov