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Completed

NCT Number: NCT01195038

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

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).

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Key information

Conditions

Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

21 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMN Investigational Site, Osaka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant Influenza HA Vaccine (H5N1)

Biological

one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain

Other names: UMN-0501

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UMN Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2010
Registry last updated
Feb 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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