Ignite Creation Date:
2024-05-05 @ 11:21 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01311817
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2011-03-08
Brief Title:
Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Transcutaneous Immunization With actAplcB-Deleted Listeria Monocytogenes Expressing Influenza A Nucleoprotein BMB72 and Cholera Toxin Adjuvant
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project is a pilot safety and immunogenicity study of transcutaneous vaccination with live attenuated Listeria monocytogenes BMB72 bacteria actAplcB-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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None