Back to resultsImmunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Recombinant Influenza HA Vaccine (H5N1)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Avian influenza, H5N1, pandemic, recombinant HA vaccine
Eligibility Criteria
Inclusion Criteria:
- Subjects who completed a priming study (JPIP501-01a, NCT00980447)
- Male and female healthy adults
- Written informed consent obtained from the subject before study entry
Exclusion Criteria:
- History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
- Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
- Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
- Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
- Treatment with disallowed drugs including other study drugs
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- UMN Investigational Site
- UMN Investigational Site
Outcomes
Primary Outcome Measures
Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)
Secondary Outcome Measures
Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses
Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01195038
Brief Title
Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
Official Title
A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMN Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Avian influenza, H5N1, pandemic, recombinant HA vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Recombinant Influenza HA Vaccine (H5N1)
Other Intervention Name(s)
UMN-0501
Intervention Description
one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain
Primary Outcome Measure Information:
Title
Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses
Time Frame
Days 7, 21
Title
Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who completed a priming study (JPIP501-01a, NCT00980447)
Male and female healthy adults
Written informed consent obtained from the subject before study entry
Exclusion Criteria:
History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
Treatment with disallowed drugs including other study drugs
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
UMN Investigational Site
City
Osaka
Country
Japan
Facility Name
UMN Investigational Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
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