Healthy Volunteers Clinical Trial
Official title:
Transcutaneous Immunization With actA/plcB-Deleted Listeria Monocytogenes Expressing Influenza A Nucleoprotein (BMB72) and Cholera Toxin Adjuvant
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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