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Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults

NCT03565315 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-12-30

Study results available
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Summary

Background:

Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV. Antibodies are naturally made by the body to fight germs. Researchers want to test if two antibodies made artificially in a lab can help to prevent HIV infection. The antibodies are 10E8VLS and VRC07-523LS.

Objective:

To see if 10E8VLS and VRC07-523LS are safe and well-tolerated and how long they stay in the blood.

Eligibility:

Healthy adults ages 18-60

Design:

Volunteers were screened in another protocol.

Participants were enrolled in 1 of 4 groups:

Group 1 participants were enrolled to receive 1 dose of 10E8VLS.

Group 2 participants were enrolled to receive 3 doses of 10E8VLS.

Group 3 participants were enrolled to receive 1 dose of both 10E8VLS and VRC07-523LS.

Group 4 participants were enrolled to receive 3 doses of both 10E8VLS and VRC07-523LS.

Participants in Groups 1 and 3 were expected to be enrolled about 13 visits over 24 weeks.

Participants in Groups 2 and 4 were expected to be enrolled about 26 visits over 48 weeks.

Participants were weighed before each dose. Women may have had a pregnancy test. Participants had blood collected.

A small needle injected each dose into fatty tissue of the belly, upper arm, or thigh. Participants received between 1 and 8 injections per dose depending on their weight. Heavier participants received more injections.

Participants received a ruler and thermometer. They checked their temperature for 3 days after injection(s) and measured any redness, swelling, or bruising at the injection site.

At non-injection visits, participants had blood drawn and were checked for health changes or problems.

Conditions

  • Healthy Adult Immune Response

Interventions

BIOLOGICAL

VRC-HIVMAB095-00-AB (10E8VLS)

10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.

BIOLOGICAL

VRC-HIVMAB075-00-AB (VRC07-523LS)

VRC07-523LS 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
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2019-03-04
Completion
2019-03-04
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 NCT03565315 on ClinicalTrials.gov