A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label)

UMIN ID: UMIN000001182

Registered date:18/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Prevention of influenza pandemic
• Date of first enrollment: 2008/06/01
• Target sample size: 125
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of 5µg recombinant hemagglutinin with Alum adjuvant. 2 vaccinations, Day 0 and Day 21
Administration of 15µg recombinant hemagglutinin. 2 vaccinations, Day 0 and Day 21
Administration of 15µg recombinant hemagglutinin with Alum adjuvant. 2 vaccinations, Day 0 and Day 21
Administration of 45µg recombinant hemagglutinin. 2 vaccinations, Day 0 and Day 21
Administration of 45µg recombinant hemagglutinin with Alum adjuvant. 2 vaccinations, Day 0 and Day 21

Outcome(s)

• Primary Outcome: To investigate the safety and tolerability of 2 intramuscular doses of prepandemic recombinant hemagglutinin influenza vaccine, UMN-0501. To investigate the HAI/microneutralizaion titer after 21 days of 2 intramuscular doses of UMN-0501.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male
• Exclude criteria: Plans to receive of any other licensed vaccines during study period. Has a history of a H5 type of influenza virus infection or receipt of a H5 type influenza vaccine. Acute fever illness (greater than 39.0C) within 2 days of vaccination. Has a history of Guillan-Barre syndrome or ADEM. Has a history of immunodeficient or has a close relative with congenital immune deficiency.

Related Information

• Primary Sponsor: UMN Pharma Inc.
• Source(s) of Monetary Support: UMN Pharma Inc.