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Sponsored by: |
LigoCyte Pharmaceuticals, Inc. |
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Information provided by: | LigoCyte Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00806962 |
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls
Primary Objective:
Secondary Objectives
Evaluations of immunogenicity as determined by:
Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific cell-mediated immune (CMI) responses
Study Hypothesis:
The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events compared to placebo but similar incidence of other adverse events.
Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50 µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to adjuvant/excipients and to placebo.
Condition | Intervention | Phase |
---|---|---|
Norovirus |
Drug: Adjuvant/Excipients Device: placebo Biological: Norwalk VLP Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Randomized Double-Blind Placebo-Controlled Phase 1, Safety and Immunogenicity Study of Two Dosages of Intranasal Norwalk Virus-Like Particle Vaccine ( Norwalk VLP Antigen, MPL®, Chitosan, Mannitol, and Sucrose) Compared to Adjuvant/Excipients (MPL®, Chitosan, Mannitol, and Sucrose) and to Placebo (Empty Device |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Arms | Assigned Interventions |
---|---|
Vaccine Arm 1: Experimental
50 µg Norwalk VLP Vaccine + Adjuvant/Excipients
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Biological: Norwalk VLP Vaccine
intranasal, 50mcg, 2 doses--21 days apart
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Vaccine Arm 2: Experimental
100 µg Norwalk VLP Vaccine + Adjuvant/Excipients
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Biological: Norwalk VLP Vaccine
Intranasal, 100 mcg, 2 doses, 21 days apart
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Adjuvant/Excipients (MPL): Active Comparator
14 mg chitosan, 3 mg mannitol, 3 mg sucrose, and 50 mcg MPL
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Drug: Adjuvant/Excipients
intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart
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Empty device: Sham Comparator
Empty device that contains no dry powder formulation. Actuation of the empty intranasal delivery device will deliver a puff of air per device.
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Device: placebo
intranasal, puff of air, 2 doses, 21 days apart
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria
History of any of the following medical illnesses
Any clinically significant abnormality detected on physical examination, including:
Any lab abnormality, as listed below:
United States, Maryland | |
University of Maryland Center for Vaccine Development | Recruiting |
Baltimore, Maryland, United States | |
Contact: MaryLou Mullen, RN 410-706-6156 mmullen@medicine.umaryland.edu | |
Principal Investigator: Carol O Tacket, MD | |
Principal Investigator: Samer El-Kamery, MD, MPH | |
United States, Missouri | |
Saint Louis University | Recruiting |
Saint Louis, Missouri, United States, 63104 | |
Contact: Sharon E Frey, MD 314-977-5500 freyse@slu.edu | |
Principal Investigator: Sharon E Frey, MD | |
United States, New York | |
University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: John J Treanor, MD 585-275-5871 John_Treanor@urmc.rochester.edu | |
Principal Investigator: John J Treanor, MD | |
United States, Ohio | |
Cincinnati Children's Hospital | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Amy Cline, RN 513-636-4121 amy.cline@cchmc.org | |
Principal Investigator: David I Bernstein, MD, MA |
Principal Investigator: | Carol O Tacket, MD | University of Maryland Center for Vacccine Development |
Principal Investigator: | David I Bernstein, MD | Cincinatti Children's Hospital |
Principal Investigator: | Sharon E Frey, MD | St Louis University School of Medicine |
Principal Investigator: | John J Treanor, MD | University of Rochester |
Responsible Party: | LigoCyte Pharmaceuticals ( Richard Sublett, Director, Regulatory Affairs and Quality Assurance ) |
Study ID Numbers: | LV01-102 |
Study First Received: | December 10, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00806962 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Mannitol Chitosan |