Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
|ClinicalTrials.gov Identifier: NCT01055990|
Recruitment Status : Unknown
Verified November 2009 by Shanghai Public Health Clinical Center.
Recruitment status was: Active, not recruiting
First Posted : January 26, 2010
Last Update Posted : January 26, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza Orthomyxoviridae Infections||Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg Other: blood fix||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase1 An Observational Clinical Trial With an Influenza A (H1N1) 2009 Monovalent,Split-virion Vaccine in Healthy Adults, Aged 18-60 Years Phase2 Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||May 2010|
Heathy,aged 18-60 years,
They are healthy, are 18-60 years of age, did not have a history of infection with the 2009 H1N1 virus, and are appropriate to vaccination, without any interdictions. And they guardians confirmed that they understood the study procedures, provided written informed consent, and agreed to comply with the following visit schedule. Woman participants all are not pregnant,with a negative pregnancy test before vaccination.
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.
Experimental: clinically critical H1N1 patients
The critical H1N1 patients as recipients whose conditions are confirmed according to current standard for critical H1N1 diagnosis. The study wll research H1N1 viral load in blood of critical H1N1 patients and swab nucleic acid testing parallelity; measure H1N1 viral Load in blood and swabs (adopting Real-time PCR method) of 5 to 10 victims; and the planned blood taking time is the tenth day since the fever begins.
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
- apply blood fix to treat critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1 [ Time Frame: 30 minutes ahead of blood transfusion,6 hours, 12 hours, 24 hours and 48 hours after transfusion ]
- Hemagglutination inhibition antibody titer and Microneutralization antibody titer [ Time Frame: D0,D7,D21 ]
- local and systemic adverse reaction after vaccination [ Time Frame: Day1-21 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055990
|Shanghai Public Health Clinical Center|
|Shanghai, Shanghai, China, 201508|
|Study Director:||Hong-zhou Lu, Professor||Fudan University|