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Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults

NCT02797171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-20

Study results available
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Summary

This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC01

Administered by intravenous (IV) infusion

BIOLOGICAL

VRC01LS

Administered by intravenous (IV) infusion

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Julie McElrath · Seattle Vaccine Trials Unit

  • Linda-Gail Bekker · Desmond Tutu HIV Centre

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
2017-03-01
Primary Completion
2019-06-05
Completion
2019-06-05
FDA Drug
Yes

Countries

  • United States
  • South Africa

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 NCT02797171 on ClinicalTrials.gov