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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Shanghai Public Health Clinical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Beijing Ditan Hospital
National Institute for the Control of Pharmaceutical and Biological Products, China
Information provided by:
Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier:
NCT01055990
First received: January 25, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shanghai Public Health Clinical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemagglutination inhibition antibody titer and Microneutralization antibody titer [ Time Frame: D0,D7,D21 ] [ Designated as safety issue: No ]
  • local and systemic adverse reaction after vaccination [ Time Frame: Day1-21 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 7
Study Start Date: October 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Antiviral drugs, such as oseltamivir or zanamivir, may be effective in treating cases of swine flu, but large-scale immunization is an essential approach of controlling the pandemic.Although preliminary evidence from a matched case-control study suggests some protection from the 2008-9 trivalent inactivated vaccine against pandemic influenza A/H1N1 2009, particularly severe forms of the disease. A vaccine against H1N1 is expected to be the most effective tool for controlling influenza A (H1N1) infection.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.The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine without adjuvant when administered at the 15 ug dose.The primary immunogenicity objective is to assess the hemagglutinin antibody and neutralizing antibody response following split- virion inactivated A(H1N1) vaccine without adjuvant. Participants 148 healthy persons age 18-60 years who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is an observational, Phase II study in healthy males and non-pregnant females, aged 18-60 years.This study is designed to investigate the safety and immunogenicity of an inactivated influenza H1N1 virus vaccine after approved by the Chinese Food and Drug Administration.Following immunization, safety will be measured by assessment of adverse events through 21 days. Immunogenicity testing will be hemagglutination inhibition (HI) assays and microneutralization (MN) assays on serum obtained on the day 0,7 and 21 after vaccination.In addition, we will take clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with H1N1 vaccines to cure critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1. According to the Blood Donation Law of the People's Republic of China, the blood donation shall follow principle of voluntary.The donors should be healthy persons inoculated with specific H1N1 vaccine and their titer of H1N1 hemagglutination inhibition antibody must be 1:320 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

phase 1:

  1. Healthy male or female aged 18-60 years
  2. Volunteers are able to understand and sign the informed consent
  3. Be able to show legal identity card for the sake of recruitment
  4. Voluntarily receive a dose of influenza A (H1N1) 2009 monovalent vaccine - phase 2: 1)The donors :Healthy male or female aged 18-60 years; inoculated with specific H1N1 vaccine; titer of H1N1 hemagglutination inhibition antibody must be 1:80 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention 2)The patients: clinical H1N1patients with positive swab nucleic acid Real-time PCR test; critical H1N1 patients;fever less than 10 days;virus viremia was Preferred

Exclusion Criteria:

phase 1:

  1. Cases or cured cases of influenza A (H1N1) virus infection
  2. Women of pregnancy, lactation or about to be pregnant in recency
  3. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
  4. Autoimmune disease or immunodeficiency
  5. Guillain-Barre Syndrome
  6. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
  7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  8. Axillary temperature > 37.0 centigrade at the time of dosing
  9. Uncontrolled epilepsy, and other progressive neurological diseases
  10. Suffering from acute illness, serious chronic diseases, acute exacerbation of chronic diseases and flu
  11. Administration of any other investigational research agents within 30 days before the dosing
  12. Any other reasons that health care giver consider inappropriate to vaccination, and so on phase 2: 1)The donors :Do not meet donation requirements;the titer of H1N1 hemagglutination inhibition antibody less than 1:80 2)The patients:clinically mild H1N1 patients; fever more than 10 days;Clinicians believe that the patient was not suitable for blood fix treatment and so on
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055990

Locations
China, Shanghai
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508
Sponsors and Collaborators
Shanghai Public Health Clinical Center
Beijing Ditan Hospital
National Institute for the Control of Pharmaceutical and Biological Products, China
Investigators
Study Director: Hong-zhou Lu, Professor Fudan University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lu Hong-zhou, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT01055990     History of Changes
Other Study ID Numbers: NCT-0015
Study First Received: January 25, 2010
Last Updated: January 25, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Public Health Clinical Center:
pandemic influenza A (H1N1) 2009
blood fix treatment
influenza A (H1N1) 2009 monovalent vaccine
effectiveness
immunogenicity
safety

Additional relevant MeSH terms:
Communicable Diseases
Infection
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
RNA Virus Infections

ClinicalTrials.gov processed this record on November 20, 2014