Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

July 8, 2016

Primary Completion Date

April 25, 2022

Study Completion Date

April 25, 2022

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

Ad26.Mos4.HIV

Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5mL injection administered intramuscularly.

BIOLOGICAL

Clade C gp140

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 0.9 percent (%), 0.5 mL injection administered intramuscularly.

Trial Locations (10)

Unknown

Birmingham

San Francisco

Decatur

Silver Spring

Boston

New York

Rochester

Philadelphia

Seattle

Kigali

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT02788045 - Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults | Biotech Hunter | Biotech Hunter