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More info
You can access this
clinical trial
if you have
Healthy Volunteers
and you are
between 18 and 55
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Biological: BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01311817. The sponsor of the trial is Massachusetts General Hospital and it is looking for 8 volunteers for the current phase.
Official trial title:
Transcutaneous Immunization With actA/plcB-Deleted Listeria Monocytogenes Expressing Influenza A Nucleoprotein (BMB72) and Cholera Toxin Adjuvant