A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers

Phase 1 Completed 100 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5\*10\^10 viral particles (vp) and 1\*10\^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.

Timeline

Start: 2017-11-26
Primary completion: 2019-09-23
Completion: 2019-09-23

Publications

Salisch NC, Stephenson KE, Williams K, Cox F, van der Fits L, Heerwegh D, Truyers C, Habets MN, Kanjilal DG, Larocca RA, Abbink P, Liu J, Peter L, Fierro C, De La Barrera RA, Modjarrad K, Zahn RC, Hendriks J, Cahill CP, Leyssen M, Douoguih M, van Hoof J, Schuitemaker H, Barouch DH. A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti-Zika Virus Vaccine. Ann Intern Med. 2021 May;174(5):585-594. doi: 10.7326/M20-5306. Epub 2021 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.ZIKV.001	Vaccine	5e+10 unknown	Intramuscular
Subject	Ad26.ZIKV.001	Vaccine	1e+11 unknown	Intramuscular

Indications

No indication recorded.