Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®

Summary

Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study will look at condensed schedules. Study will randomize subjects to one of four arms.

Timeline

Start

2013-06

Primary completion

2015-04

Completion

2015-04

Outcome

Missed primary endpoint

paper Non-inferiority of the PRNT antibody response was not established for any of the three non-standard study arms. PMID 28256358 ↗

Publications

• Jackson LA, Frey SE, El Sahly HM, Mulligan MJ, Winokur PL, Kotloff KL, Campbell JD, Atmar RL, Graham I, Anderson EJ, Anderson EL, Patel SM, Fields C, Keitel W, Rouphael N, Hill H, Goll JB. Safety and immunogenicity of a modified vaccinia Ankara vaccine using three immunization schedules and two modes of delivery: A randomized clinical non-inferiority trial. Vaccine. 2017 Mar 23;35(13):1675-1682. doi: 10.1016/j.vaccine.2017.02.032. Epub 2017 Feb 27.

Drugs

Indications