Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients

Summary

The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1, commonly known as swine flu, that was first identified in April 2009. Large-scale immunization is an essential approach of controlling the pandemic.Vaccines are now becoming available for protection against pandemic influenza A(H1N1) 2009 infection in some countries.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China. However, the safety and effectiveness of the vaccines is of prime concern to the authorities and the public.This report details the findings of a observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009 monovalent vaccine.

The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However, clinically, the investigators have encountered that this virus can infect resistant strains of Oseltamivir, which urges for a more effective treatment plan.

In view of above situations, seeking for an effective measures against H1N1 flu should be a top priority and will benefit human life and economy globally. This Topic will take the classic strategy of passive immunity to perform basic and clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with specific H1N1 vaccines to cure critical H1N1 patients.

Conditions

• Virus Diseases
• Respiratory Tract Diseases
• Respiratory Tract Infections
• Influenza
• Orthomyxoviridae Infections

Interventions

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

The influenza A (H1N1) 2009 monovalent, (Split-virion)inactivated vaccine was developed by Shanghai Institute of Biological Products, and the seed virus was prepared from reassortant vaccine virus A/California/7/2009,distributed by the Centers for Disease Control and Prevention in the United States. This strain was recommended by the World Health Organization and obtained from the Chinese Food and Drug Administration.The vaccine adopted the assessment of experts, and formally accessed to the approval document number of production and new drug certificate issued by the Chinese Food and Drug Administration.

OTHER

blood fix

The blood fix with a hemagglutination-inhibition titer of 1:80 or more than was collected from healthy persons who are inoculated with specific H1N1 vaccine

Sponsors & Collaborators

• Beijing Ditan Hospital

  collaborator OTHER

• National Institute for the Control of Pharmaceutical and Biological Products, China

  collaborator OTHER

• Shanghai Public Health Clinical Center

  lead OTHER_GOV

Principal Investigators

• Hong-zhou Lu, Professor · Fudan University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2010-04-30

Completion

2010-05-31

Countries

• China

Study Locations