HIV-V-A003
Status:Completed
Phase:I
Principal Investigator(s):Crucell Holland BV
Objective: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.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionBiological: gp140, 50 mcg
Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionBiological: 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.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionBiological: gp140, 250 mcg
The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionBiological: 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.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT02304185
Trial Sponsors:
Beth Israel Deaconess Medical Center, Crucell Holland, NIAID
Start Date
End Date
December 11, 2014
March 11, 2016
Enrollment:50
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women