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

This study has been completed.
Sponsor:
Information provided by:
UMN Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01195038
First received: September 2, 2010
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

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).


Condition Intervention Phase
Influenza
Biological: Recombinant Influenza HA Vaccine (H5N1)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by UMN Pharma Inc.:

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) [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

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 [ Time Frame: Days 7, 21 ] [ Designated as safety issue: No ]
  • Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 87
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Recombinant Influenza HA Vaccine (H5N1)
    one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain
    Other Name: UMN-0501
  Eligibility

Ages Eligible for Study:   21 Years to 41 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195038

Locations
Japan
UMN Investigational Site
Osaka, Japan
UMN Investigational Site
Tokyo, Japan
Sponsors and Collaborators
UMN Pharma Inc.
  More Information

No publications provided

Responsible Party: UMN Pharma, Clinical Research Division
ClinicalTrials.gov Identifier: NCT01195038     History of Changes
Other Study ID Numbers: JPIP501-01b
Study First Received: September 2, 2010
Last Updated: February 7, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UMN Pharma Inc.:
Avian influenza, H5N1, pandemic, recombinant HA vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014