NCT02685020View on ClinicalTrials.gov

Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 28, 2016

Primary Completion Date

January 5, 2018

Study Completion Date

January 3, 2019

Conditions
Healthy
Interventions
BIOLOGICAL

Ad26.Mos.HIV

Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.

BIOLOGICAL

Clade C gp140

The Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.

DRUG

Placebo

Normal saline, 0.5 mL injection administered intramuscularly.

Trial Locations (1)

Unknown

Boston

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT02685020 - Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults | Biotech Hunter | Biotech Hunter