Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

393

Participants

Timeline

Start Date

December 22, 2014

Primary Completion Date

August 29, 2017

Study Completion Date

March 28, 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 envelop (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

MVA-Mosaic

Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10\^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.

BIOLOGICAL

gp140 DP Low-dose

The gp140 DP vaccine containing 50 mcg of total protein, mixed with aluminum phosphate adjuvant (0.425 mg aluminum), per 0.5 mL injection administered intramuscularly.

BIOLOGICAL

gp140 DP High-dose

The gp140 DP 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 (12)

Unknown

Aurora

Miami

Rockville

Boston

Austin

Kigali

Cape Town

Durban

Johannesburg

Bangkok

Entebbe

Kampala

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

US Military HIV Research Program

NETWORK

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

International AIDS Vaccine Initiative

NETWORK

lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT02315703 - Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention | Biotech Hunter | Biotech Hunter