Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). 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.
Primary Outcome
Safety is measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions
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 |
What the finished NCT01311817 record still lists
NCT01311817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01311817's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia