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

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ClinicalTrials.gov Identifier: NCT01195038
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : February 8, 2011
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Influenza Biological: Recombinant Influenza HA Vaccine (H5N1) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination [ Time Frame: 21 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 41 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195038


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

Responsible Party: UMN Pharma, Clinical Research Division
ClinicalTrials.gov Identifier: NCT01195038     History of Changes
Other Study ID Numbers: JPIP501-01b
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs