Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

Phase 2

Completed

• Conditions: Influenza

• Registration Number: NCT01195038
• Lead Sponsor: UMN Pharma Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Study Start: 2010-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-07
• Last Update Posted: 2011-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	Day 21

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination	21 days
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	Days 7, 21

Trial Locations

Locations (1)

UMN Investigational Site; 🇯🇵 Tokyo, Japan