A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

March 31, 2017

Primary Completion Date

November 22, 2023

Study Completion Date

November 22, 2023

Conditions
Healthy
Interventions
BIOLOGICAL

Ad26.Mos4.HIV

Ad26.Mos4.HIV at a dose of 5\*10\^10 viral particles (vp), administered intramuscularly.

BIOLOGICAL

Clade C gp140 plus adjuvant

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

BIOLOGICAL

Clade C gp140/Mosaic gp140 plus adjuvant

Clade C gp140 and Mosaic gp140 (each 125 mcg of total protein) mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection, administered intramuscularly.

OTHER

Placebo

Placebo Containing 0.9 percent normal saline, administered intramuscularly.

BIOLOGICAL

gp140 HIV Bivalent Vaccine

gp140 HIV Bivalent Vaccine is adjuvanted protein co-formulation with a dosage strength of 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant).

Trial Locations (13)

780

Center for Family Health Research/Project San Francisco, Kigali

10032

Columbia University HIV Vaccine Unit, New York

10065

New York Blood Center, New York

14642

Strong Memorial Infectious Disease, Rochester

19104

University of Pennsylvania, Philadelphia

20200

Walter Reed Project Clinical Research Center, Kericho

35294

Alabama Vaccine Research Clinic at UAB, Birmingham

98104

Seattle Vaccine Trials Unit, Seattle

94102-4594

Bridge HIV, San Francisco

30030-1705

The Hope Clinic at Emory University, Decatur

02115

Brigham And Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Fenway Health, Boston

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT02935686 - A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults | Biotech Hunter | Biotech Hunter