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| Sponsor: | LigoCyte Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | LigoCyte Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00806962 |
Purpose
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 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vaccine Arm 1: Experimental
50 µg Norwalk VLP Vaccine + Adjuvant/Excipients
|
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.
|
Device: placebo
intranasal, puff of air, 2 doses, 21 days apart
|
Eligibility| 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:
Contacts and Locations| United States, Maryland | |
| University of Maryland Center for Vaccine Development | |
| Baltimore, Maryland, United States | |
| United States, Missouri | |
| Saint Louis University | |
| Saint Louis, Missouri, United States, 63104 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Cincinnati Children's Hospital | |
| Cincinnati, Ohio, United States, 45229 | |
| 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 |
More Information
| 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: | September 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00806962 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |