Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
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ClinicalTrials.gov Identifier: NCT02013687 |
Recruitment Status :
Completed
First Posted : December 17, 2013
Results First Posted : January 18, 2017
Last Update Posted : March 8, 2017
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Sponsor:
Fraunhofer, Center for Molecular Biotechnology
Information provided by (Responsible Party):
Fraunhofer, Center for Molecular Biotechnology
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Tracking Information | |||
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First Submitted Date ICMJE | November 25, 2013 | ||
First Posted Date ICMJE | December 17, 2013 | ||
Results First Submitted Date ICMJE | November 21, 2016 | ||
Results First Posted Date ICMJE | January 18, 2017 | ||
Last Update Posted Date | March 8, 2017 | ||
Study Start Date ICMJE | October 2013 | ||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 420 days ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults | ||
Official Title ICMJE | A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults | ||
Brief Summary | This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Malaria | ||
Intervention ICMJE | Biological: Pfs25 VLP- FhCMB | ||
Study Arms ICMJE |
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Publications * | Chichester JA, Green BJ, Jones RM, Shoji Y, Miura K, Long CA, Lee CK, Ockenhouse CF, Morin MJ, Streatfield SJ, Yusibov V. Safety and immunogenicity of a plant-produced Pfs25 virus-like particle as a transmission blocking vaccine against malaria: A Phase 1 dose-escalation study in healthy adults. Vaccine. 2018 Sep 18;36(39):5865-5871. doi: 10.1016/j.vaccine.2018.08.033. Epub 2018 Aug 17. | ||
* 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 | Completed | ||
Actual Enrollment ICMJE |
44 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | January 2015 | ||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02013687 | ||
Other Study ID Numbers ICMJE | FhCMB Pfs25-001 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Fraunhofer, Center for Molecular Biotechnology | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Fraunhofer, Center for Molecular Biotechnology | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Fraunhofer, Center for Molecular Biotechnology | ||
Verification Date | January 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |