Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine

Summary

This project is a pilot safety and immunogenicity study of transcutaneous vaccination with live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin. Transcutaneous vaccination is needle-less application of materials directly to the skin. Healthy adult volunteers (4 per group) will receive either: * Saline (placebo) * Cholera toxin adjuvant alone * L. monocytogenes BMB72 bacteria alone * L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm dressing. Key primary endpoints include: safety as measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions), and immune responses as measured by serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses will be evaluated by skin biopsy in subjects who agree to that (optional). The study will begin with 2 "roll-in" subjects receiving both L. monocytogenes and CT.

Timeline

Start

2011-01

Primary completion

2012-07

Completion

2012-07

Publications

• Eypper EH, Johnson PV, Purro EI, Hohmann EL. Transcutaneous immunization of healthy volunteers with an attenuated Listeria monocytogenes vaccine strain and cholera toxin adjuvant. Vaccine. 2013 Jul 11;31(32):3257-61. doi: 10.1016/j.vaccine.2013.05.028. Epub 2013 May 22.

Drugs

Indications

No indication recorded.