Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin (FDA-OPD)
This study is currently recruiting participants.
Verified August 2012 by FDA Office of Orphan Products Development
Sponsor:
Information provided by (Responsible Party):
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00812071
First received: December 15, 2008
Last updated: August 28, 2012
Last verified: August 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 15, 2008 | ||||
| Last Updated Date | August 28, 2012 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
assess the safety of 3 dose levels [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00812071 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
determine the immunogenicity of the 3 dose levels [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin | ||||
| Official Title ICMJE | Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults | ||||
| Brief Summary | Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Biological: RiVax
vaccine |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | January 2013 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 31 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00812071 | ||||
| Other Study ID Numbers ICMJE | 3369-01, 1R01FD-03369--01-A1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | FDA Office of Orphan Products Development | ||||
| Study Sponsor ICMJE | FDA Office of Orphan Products Development | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | FDA Office of Orphan Products Development | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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