NCT02304185View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

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.

Trial Locations (1)

Unknown

Miami

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Beth Israel Deaconess Medical Center

OTHER

lead

Crucell Holland BV

INDUSTRY

NCT02304185 - Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers | Biotech Hunter | Biotech Hunter