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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

NCT01195038

Influenza

COMPLETED PHASE2

Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

NCT00517517

Influenza

COMPLETED PHASE1/PHASE2

Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

NCT00989612

Influenza

COMPLETED PHASE2

Revaccination With Subunit Influenza A/Vietnam/1203/2004 (H5N1) Vaccine

NCT00240903

Influenza

COMPLETED PHASE1

Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

NCT00664417

Influenza Orthomyxoviridae Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Virus Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

UMN-0501 45µg

Recombinant H5N1 vaccine 45µg

Group Type EXPERIMENTAL

UMN-0501

Intervention Type BIOLOGICAL

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart

UMN-0501 90µg

Recombinant H5N1 vaccine 90µg

Group Type EXPERIMENTAL

UMN-0501

Intervention Type BIOLOGICAL

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart

UMN-0501 135µg

Recombinant H5N1 vaccine 135µg

Group Type EXPERIMENTAL

UMN-0501

Intervention Type BIOLOGICAL

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UMN-0501

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart

Intervention Type BIOLOGICAL

UMN-0501

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart

Intervention Type BIOLOGICAL

UMN-0501

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

UMN-05 UMN-05 UMN-05

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes