NCT03307915View on ClinicalTrials.gov

A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 5, 2018

Primary Completion Date

November 5, 2021

Study Completion Date

November 5, 2021

Conditions
Human Immunodeficiency Virus
Interventions
BIOLOGICAL

Ad26.Mos4.HIV

Participants will receive Ad26.Mos4.HIV 5\*10\^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.

BIOLOGICAL

MVA-Mosaic

Participants will receive MVA-Mosaic 10\^8 pfu as IM injection at Weeks 24 and 36.

BIOLOGICAL

Clade C gp140 + Mosaic gp140

Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.

DRUG

Placebo

Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.

Trial Locations (1)

02215

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Ragon Institute of MGH, MIT and Harvard

OTHER

collaborator

US Military HIV Research Program

NETWORK

lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT03307915 - A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment | Biotech Hunter | Biotech Hunter