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

Influenza Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980447
• Other study ID #: JPIP501-01a
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2009
• Last updated: February 5, 2010
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: UMN Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.

• Males and females aged 20-40 years.

• Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.

Exclusion Criteria:

• Body Mass Index (BMI) 30 kg/m2 and above.

• Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.

• Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.

• Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).

• Has severe allergic diseases.

• Has asthma.

• Has a history of convulsions.

• Has a history of any serious disease.

• Known impairment of imune function.

• Known rheumatism and autoimmune disease.

• Receipt of medicines that would affect evaluation of immunogenicity.

• Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment.

• Blood donation prior to enrollment.

• Receipt of another investigation agent prior to enrollment.

• History of alcohol or drug abuse.

• Females who are pregnant or potentially childbearing or are breastfeeding.

• Ineligible subject based on the judgement of the investigator.

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Virus Diseases

Intervention

Biological:
• UMN-0501
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart
• UMN-0501
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart
• UMN-0501
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart

Locations

Country	Name	City	State
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachinagano City	Osaka
Japan	National Hospital Organization Tokyo Medical Center	Meguro-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects who achieve seroconversion, seroprotection, GMTs and GMT ratio to baseline, 21 days after the 2nd vaccination defined by serum neutralizing and HAI titers against the influenza H5N1 A/Vietnam/1203/2004 virus.		Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)	No
Primary	Frequencies of AEs including vaccine-related reactogenicity events.		Throughout study period: Day0 to 42	Yes
Secondary	To explore T-cell response in the subset of subjects after each vaccination as determined by proliferation and cytokine production capacity of T-cells re-stimulate by H5N1 A/Vietnam/1203/2004 recombinant virus antigens.		Day0, Day 21 and Day 42	No