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A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine

NCT00412477 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-10-10

No results posted yet for this study

Summary

To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly

To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIV LFn-p24

HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed at 200 µg/ml and 600 µglml. The product will be administered IM in doses ranging from 150µg to 450µg with Alhydrogel.

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • CDR Shirley Lee-Lecher, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-08-20
Primary Completion
2006-03-13
Completion
2006-11-01
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 NCT00412477 on ClinicalTrials.gov