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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195038
• Other study ID #: JPIP501-01b
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2010
• Last updated: February 7, 2011
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: UMN Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 41 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Recombinant Influenza HA Vaccine (H5N1)
one booster dose of 45 µg rHA derived from A/Indonesia/05/2005 strain

Locations

Country	Name	City	State
Japan	UMN Investigational Site	Osaka
Japan	UMN Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination		21 days	Yes