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

2014-08-27 03:19:12 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

UMN-0501, UMN-0501, UMN-0501

Location

National Hospital Organization Osaka Minami Medical Center
Kawachinagano City
Osaka
Japan
586-8521

Status

Completed

Source

UMN Pharma Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:12-0400

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Medical and Biotech [MESH] Definitions

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

A genus of the family ORTHOMYXOVIRIDAE comprising viruses similar to types A and B but less common, more stable, more homogeneous, and lacking the neuraminidase protein. They have not been associated with epidemics but may cause mild influenza. Influenza C virus is the type species.

A genus in the family ORTHOMYXOVIRIDAE causing influenza and other diseases in humans and animals. It contains many strains as well as antigenic subtypes of the integral membrane proteins hemagglutinin (HEMAGGLUTININS) and NEURAMINIDASE. The type species is INFLUENZA A VIRUS.

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