NCT00980447

Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

A Multicenter, Non-Blinded, Dose Escalation Study to Evaluate the Immunogenicity, Safety and Optimal Dose of Three Doses Regimen of Recombinant Influenza H5N1 Vaccine, After Two Vaccinations Given 3 Weeks Apart, in Healthy Young Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: UMN Pharma Inc. · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

Conditions

• Influenza
• Virus Diseases

Interventions

Type	Name	Description
BIOLOGICAL	UMN-0501	2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart
BIOLOGICAL	UMN-0501	2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart
BIOLOGICAL	UMN-0501	2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-09-21
• Last updated: 2010-02-08

Locations

2 sites across 1 country: Japan