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NCT01311817 · ClinicalTrials.gov registry record · Phase 1
Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01311817: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01311817 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01311817, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01311817
The ClinicalTrials.gov registry entry for NCT01311817 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein) is the first listed.
NCT01311817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01311817 about?
NCT01311817 is a clinical study titled "Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine". 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-les...
What is the current status of trial NCT01311817?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-01. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01311817?
The interventions under investigation include: BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01311817?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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