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

NCT01055990 | Unknown Phase 2 DMC

• 1 other identifier: NCT-0015
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pandemic influenza A (H1N1) 2009; blood fix treatment; influenza A (H1N1) 2009 monovalent vaccine; effectiveness; immunogenicity; safety

Outcome Measures

Primary Outcomes (1)

• 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

  30 minutes ahead of blood transfusion,6 hours, 12 hours, 24 hours and 48 hours after transfusion

Secondary Outcomes (2)

• Hemagglutination inhibition antibody titer and Microneutralization antibody titer

  D0,D7,D21

• local and systemic adverse reaction after vaccination

  Day1-21

Study Arms (2)

Heathy,aged 18-60 years,

OTHER

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

clinically critical H1N1 patients

EXPERIMENTAL

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

Interventions

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

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.

Heathy,aged 18-60 years,

blood fix OTHER

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

clinically critical H1N1 patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• phase 1：
• Healthy male or female aged 18-60 years
• Volunteers are able to understand and sign the informed consent
• Be able to show legal identity card for the sake of recruitment
• 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

You may not qualify if:

• phase 1:
• Cases or cured cases of influenza A (H1N1) virus infection
• Women of pregnancy, lactation or about to be pregnant in recency
• 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
• Autoimmune disease or immunodeficiency
• Guillain-Barre Syndrome
• Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
• 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
• Axillary temperature \> 37.0 centigrade at the time of dosing
• Uncontrolled epilepsy, and other progressive neurological diseases
• Suffering from acute illness, serious chronic diseases, acute exacerbation of chronic diseases and flu
• Administration of any other investigational research agents within 30 days before the dosing
• 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

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead
• Beijing Ditan Hospital: collaborator
• National Institute for the Control of Pharmaceutical and Biological Products, China: collaborator

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

Related Publications (5)

• Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.

  PMID: 19846844 BACKGROUND

• Wu J, Fang HH, Chen JT, Zhou JC, Feng ZJ, Li CG, Qiu YZ, Liu Y, Lu M, Liu LY, Dong SS, Gao Q, Zhang XM, Wang N, Yin WD, Dong XP. Immunogenicity, safety, and cross-reactivity of an inactivated, adjuvanted, prototype pandemic influenza (H5N1) vaccine: a phase II, double-blind, randomized trial. Clin Infect Dis. 2009 Apr 15;48(8):1087-95. doi: 10.1086/597401.

  PMID: 19281330 BACKGROUND

• Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.

  PMID: 19745216 BACKGROUND

• Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.

  PMID: 19745215 BACKGROUND

• Sun F, Zhang Y, Tian D, Zheng M, Liu L, Zhang R, Dai Z, Chen J, Li T, Lu H. Responses after one dose of a monovalent influenza A (H1N1) 2009 inactivated vaccine in Chinese population--a practical observation. Vaccine. 2011 Sep 2;29(38):6527-31. doi: 10.1016/j.vaccine.2011.07.006. Epub 2011 Jul 19.

  PMID: 21767595 DERIVED

Related Links

• Click here for more information about this disease:The Pandemic influenza A (H1N1) 2009
• Related Info

MeSH Terms

Conditions

Virus Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Infections; RNA Virus Infections

Study Officials

• Hong-zhou Lu, Professor

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 26, 2010

Record last verified: 2009-11

Locations

CN (1)