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

Summary

The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.

Timeline

Start

2016-07-08

Primary completion

2022-04-25

Completion

2022-04-25

Publications

• Baden LR, Stieh DJ, Sarnecki M, Walsh SR, Tomaras GD, Kublin JG, McElrath MJ, Alter G, Ferrari G, Montefiori D, Mann P, Nijs S, Callewaert K, Goepfert P, Edupuganti S, Karita E, Langedijk JP, Wegmann F, Corey L, Pau MG, Barouch DH, Schuitemaker H, Tomaka F; Traverse/HVTN 117/HPX2004 Study Team. Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study. Lancet HIV. 2020 Oct;7(10):e688-e698. doi: 10.1016/S2352-3018(20)30229-0.

Drugs

Indications

No indication recorded.