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

Phase 1/2 Completed 155 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupDouble-blindPrevention

Summary

The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.

Timeline

Start: 2017-03-31
Primary completion: 2023-11-22
Completion: 2023-11-22

Publications

Stieh DJ, Barouch DH, Comeaux C, Sarnecki M, Stephenson KE, Walsh SR, Sawant S, Heptinstall J, Tomaras GD, Kublin JG, McElrath MJ, Cohen KW, De Rosa SC, Alter G, Ferrari G, Montefiori D, Mann P, Nijs S, Callewaert K, Goepfert PA, Edupuganti S, Karita E, Seaman MS, Corey L, Baden LR, Pau MG, Schuitemaker H, Tomaka F; ASCENT/HVTN118/HPX2003 Study Team. Safety and Immunogenicity of Ad26-Vectored HIV Vaccine With Mosaic Immunogens and a Novel Mosaic Envelope Protein in HIV-Uninfected Adults: A Phase 1/2a Study. J Infect Dis. 2023 Apr 18;227(8):939-950. doi: 10.1093/infdis/jiac445.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.Mos4.HIV	Vaccine	5e+10 unknown	Intramuscular
Subject	Clade C gp140	Vaccine	250 ug	Intramuscular
Subject	Mosaic gp140	Unknown	125 ug	Intramuscular
Subject	gp140 HIV Bivalent Vaccine	Vaccine	75 ug	—
Subject	gp140 HIV Bivalent Vaccine	Vaccine	80 ug	—
Background	Aluminum Phosphate	Unknown	—	Intramuscular

Indications

No indication recorded.