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)

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) - A phase I/II clinical study of UMN-0501 for healthy adult males (single center, ascending dose, open label study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001182

Enrollment

125

Registered

2008-06-18

Start date

2008-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza pandemic

Interventions

Administration of 5&amp

micro

g recombinant hemagglutinin with Alum adjuvant. 2 vaccinations, Day 0 and Day 21 Administration of 15&amp

g recombinant hemagglutinin. 2 vaccinations, Day 0 and Day 21 Administration of 15&amp

g recombinant hemagglutinin with Alum adjuvant. 2 vaccinations, Day 0 and Day 21 Administration of 45&amp

g recombinant hemagglutinin. 2 vaccinations, Day 0 and Day 21 Administration of 45&amp

g recombinant hemagglutinin with Alum adjuvant. 2 vaccinations, Day 0 and Day 21

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy adult males ages 20-40 years. Provides informed consent prior to any study procedures.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

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&#39;s safety, tolerability and immunogenicity. (single center, ascending doses, open label)