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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014