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Sponsored by: |
Protein Sciences Corporation |
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Information provided by: | Protein Sciences Corporation |
ClinicalTrials.gov Identifier: | NCT00328107 |
The objective of the study was to determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent purified influenzavirus hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses in healthy adults.
Condition | Intervention | Phase |
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Influenza |
Biological: Influenza Vaccine, recombinant Hemagglutinin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Immunogenicity and Safety of Two Preparations of Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly in Healthy Adults Ages 18-49 Years. |
Enrollment: | 459 |
Study Start Date: | November 2004 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Low Dose: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45mcg hemagglutinin derived from H3 virus and 15 mcg from H1 and B influenza viruses
|
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
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High Dose: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45mcg hemagglutinin derived from H1, H3 and B influenza viruses
|
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
|
Background We assessed the efficacy of a recombinant hemagglutinin vaccine without adjuvant or neuraminidase in healthy subjects during the 2004-2005 influenza season.
Methods We recruited 460 healthy subjects of the age 18-49 at three different sites in the United States for this double-blinded trial; the subjects were randomly assigned to receive a single injection of placebo (154 subjects) or 75μg of a trivalent recombinant hemagglutinin vaccine containing 15μg hemagglutinin derived from either A/New Caledonia/20/99 or B/Jiangsu/10/03 influenza viruses and 45μg hemagglutinin derived from A/Wyoming/3/03 influenza virus (153 subjects) or 135μg of trivalent recombinant hemagglutinin vaccine containing 3 x 45μg hemagglutinin (153 subjects). The subjects were followed during the influenza season or 6 months following injection. Serum samples were taken at time points 0, day 30 and 6 months following injection. In addition, nasal swaps were taken from individuals that presented with influenza-like illness (CDC-ILI).
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 | |
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | John Treanor, MD | University of Rochester |
Responsible Party: | Protein Sciences Corporation ( Manon MJ Cox ) |
Study ID Numbers: | PSC01 |
Study First Received: | May 17, 2006 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00328107 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |