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| Descriptive Information Fields | |||||
| Brief Title † | Invaplex 50 Vaccine Dose-Ranging | ||||
| Official Title † | Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine | ||||
| Brief Summary | The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits. |
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| Detailed Description | This is an open-labeled dose escalating trial in which a total of 32 subjects (minimum of 24 allowable) will receive one of four intranasal Invaplex 50 vaccine doses according to the following chart: Test articles/dose Group / N* / Invaplex 50 A / 8 / 10 micrograms B / 8 / 50 micrograms C / 8 / 240 micrograms D / 8 / 480 micrograms *minimum of 6 volunteers/group An interval no less than 7 days following the third (and final) dose (total of 35 days between initial dose at the lower dose level and the next initial dose at the next higher dose level) will separate volunteer groups receiving different doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+- one day), and the third is Day 28 (+- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccination dose. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Safety Mucosal immune response Systemic immune response |
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| Secondary Outcome Measure † | |||||
| Condition † | Diarrhea | ||||
| Intervention † | Biological: Shigella flexneri 2a Invaplex 50 | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical Trials Center website ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 32 | ||||
| Start Date † | April 2004 | ||||
| Completion Date | November 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00082069 | ||||
| Organization ID | NMRC 2003.0008 | ||||
| Secondary IDs †† | WRAIR 1085, HSRRB A-12528, Invaplex50 | ||||
| Study Sponsor † | U.S. Army Office of the Surgeon General | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Walter Reed Army Institute of Research (WRAIR) | ||||
| Verification Date | November 2006 | ||||
| First Received Date † | April 28, 2004 | ||||
| Last Updated Date | November 1, 2006 | ||||