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Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers

NCT02304185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-06-06

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodeficiency virus (HIV)-uninfected participants.

Conditions

  • Healthy

Interventions

BIOLOGICAL

gp140, 50 mcg

Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.

BIOLOGICAL

gp140, 50 mcg + Adjuvant

The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.

BIOLOGICAL

gp140, 250 mcg

The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.

BIOLOGICAL

gp140, 250 mcg + Adjuvant

The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.

DRUG

Placebo

Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.

Sponsors & Collaborators

Principal Investigators

  • Crucell Holland BV Clinical Trials · Crucell Holland BV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02304185 on ClinicalTrials.gov