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Sponsors and Collaborators: |
VaxInnate Corporation University of Rochester |
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Information provided by: | VaxInnate Corporation |
ClinicalTrials.gov Identifier: | NCT00730457 |
Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.
Condition | Intervention | Phase |
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Influenza |
Biological: VAX125 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Two Part Study to Investigate the Safety and Immunogenicity of the VAX125 Influenza Vaccine in Healthy Adults Age 18-49 Years Part I: Phase I, Open-Label, Escalating Dose-Ranging Study Part II: Phase II, Double-Blind Placebo-Controlled Study |
Estimated Enrollment: | 104 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Intramuscular (i.m.) vaccination of a single dose of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg and 8 µg of STF2.HA1 (SI) (VAX125).
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Biological: VAX125
Single intramuscular dose
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Part I: Intramuscular (i.m.) vaccination of a single dose of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg and 8 µg of STF2.HA1 (SI) (VAX125) to be given on Day 0
Part II: Intramuscular (i.m.) vaccination of a single dose of placebo or one of two dose levels of STF2.HA1 (SI) (VAX125) (optimum dose levels to be determined from the safety and immunogenicity data from Part I of this study) to be given on Day 0
Part I Primary: To assess the safety, reactogenicity, and tolerability of the VAX125 vaccine delivered i.m. in a single dose regimen of dose levels of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg, and 8 µg in healthy adults 18 - 49 years of age, inclusive.
Secondary: To assess the immunogenicity of the VAX125 vaccine delivered i.m. in a single dose regimen at dose levels of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg, and 8 µg, for inducing a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.
Part II Primary: To assess the safety, reactogenicity, and tolerability of a single dose of the VAX125 vaccine delivered i.m. in one of two dose levels as compared to placebo, (optimum dose levels to be determined from the safety and immunogenicity data from Part I of this study), in healthy adults 18- 49 years of age, inclusive.
Secondary: To assess the immunogenicity of a single dose the VAX125 vaccine delivered i.m. in one of two dose levels as compared to placebo (optimum dose levels to be determined from the safety and immunogenicity data from Part I of this study) for inducing a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA antigen.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: David N Taylor, MD | 609-860-2289 | david.taylor@vaxinnate.com |
Contact: Virginia Suppers | 609-860-2857 | virginia.suppers@vaxinnate.com |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: John Treanor, MD 585-275-5871 john_treanor@urmc.rochester.edu | |
Contact: Gail Quinlan 585-275-3473 gail_quinlan@urmc.rochester.edu | |
Principal Investigator: John J Treanor, MD |
Principal Investigator: | John J Treanor, MD | University of Rochester |
Responsible Party: | VaxInnate Corp ( David Taylor/Chief Medical Officer ) |
Study ID Numbers: | VAX125-01 |
Study First Received: | August 4, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00730457 |
Health Authority: | United States: Food and Drug Administration |
influenza recombinant hemagglutinin vaccine |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |