drugset

drugset / Trial / NCT02366013

Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine

NCT02366013 ↗

Phase 1 Completed 22 enrolled International AIDS Vaccine Initiative Beth Israel Deaconess Medical Center · collab University of Rochester · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1 vaccine.

Timeline

Start: 2015-01
Primary completion: 2016-06
Completion: 2016-06

Publications

Stephenson KE, Keefer MC, Bunce CA, Frances D, Abbink P, Maxfield LF, Neubauer GH, Nkolola J, Peter L, Lane C, Park H, Verlinde C, Lombardo A, Yallop C, Havenga M, Fast P, Treanor J, Barouch DH. First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1. PLoS One. 2018 Nov 14;13(11):e0205139. doi: 10.1371/journal.pone.0205139. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rcAd26.MOS1.HIV-Env	Vaccine	1e+08 unknown	Oral
Subject	rcAd26.MOS1.HIV-Env	Vaccine	1e+09 unknown	Oral
Subject	rcAd26.MOS1.HIV-Env	Vaccine	1e+10 unknown	Oral
Subject	rcAd26.MOS1.HIV-Env	Vaccine	1e+11 unknown	Oral

Indications