Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine
Primary Purpose
Pandemic Influenza, Prevention
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
Sponsored by
About this trial
This is an interventional prevention trial for Pandemic Influenza
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged 18-60 years old
- Be able to show legal identity card for the sake of recruitment
- Be able to understand and sign the informed consent.
Exclusion Criteria:
- Woman: Who breast-feeding or planning to become pregnant during the 56 days of study participation
- Any history of allergic reactions was allergic to any component of the vaccine, such as eggs or ovalbumin;
- Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
- Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
- 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
- Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
Seizure disorder other than:
- Febrile seizures under the age of two years old,
- Seizures secondary to alcohol withdrawal more than 3 years ago, or
- A singular seizure not requiring treatment within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
- Guillain-Barre Syndrome
- Women subjects with positive urinary pregnancy test
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- History of any blood products administration within 3 months before the dosing
- Administration of any other investigational research agents within 30 days before the dosing
- Administration of any live attenuated vaccine within 30 days before the dosing
- Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
- Be receiving anti-TB prophylaxis or therapy currently
- Axillary temperature >37.0 centigrade at the time of dosing
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1: 10 ug, 14 days
2: 5 ug, 28 days
3: 10 ug, 28 days
4: 15 ug, 28days
Arm Description
Outcomes
Primary Outcome Measures
HI antibody and Neutralization antibody
Secondary Outcome Measures
adverse reactions
Full Information
NCT ID
NCT00535665
First Posted
September 24, 2007
Last Updated
November 8, 2007
Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Centers for Disease Control and Prevention, China
1. Study Identification
Unique Protocol Identification Number
NCT00535665
Brief Title
Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine
Official Title
The Clinical Trial of Pandemic Influenza Vaccine (Whole-Virion, Inactivated, Adjuvanted) on Healthy Adults by Randomized and Double-Blind Design: a Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Centers for Disease Control and Prevention, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A single center, randomized and double-blind phase II clinical trial is to be conducted in adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine (whole-virion, aluminium-adjuvanted).
Detailed Description
The vaccine to be investigated is producted in embryonated hen's eggs using an H5N1 reference strain NIBRG-14 which was prepared by NIBSC. The strain is a reassortant between A/Vietnam/1194/2004 and A/PR/8/34 by reverse genetics.
Total 400 volunteers aged from 18 to 60 years old are to be enrolled with 100 subjects in each group. The eligible volunteers will receive two doses vaccine of 5μg,10μg or 15μg haemagglutinin antigen. The schedule is day 0,14 or day 0,28. The subjects will donate their blood samples for the detection of HI antibody and microneutralization antibody. Local and systematic adverse reactions will be recorded during the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pandemic Influenza, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: 10 ug, 14 days
Arm Type
Experimental
Arm Title
2: 5 ug, 28 days
Arm Type
Experimental
Arm Title
3: 10 ug, 28 days
Arm Type
Experimental
Arm Title
4: 15 ug, 28days
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention Description
two-dose regimen with 14 days apart: 5 microgram per dose
Intervention Type
Biological
Intervention Name(s)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention Description
two-dose regimen with 28 days apart: 5 microgram per dose
Intervention Type
Biological
Intervention Name(s)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention Description
two-dose regimen with 28 days apart: 10 microgram per dose
Intervention Type
Biological
Intervention Name(s)
pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention Description
two-dose regimen with 28 days apart: 15 microgram per dose
Primary Outcome Measure Information:
Title
HI antibody and Neutralization antibody
Time Frame
0,28,42,56
Secondary Outcome Measure Information:
Title
adverse reactions
Time Frame
0,28,42,56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged 18-60 years old
Be able to show legal identity card for the sake of recruitment
Be able to understand and sign the informed consent.
Exclusion Criteria:
Woman: Who breast-feeding or planning to become pregnant during the 56 days of study participation
Any history of allergic reactions was allergic to any component of the vaccine, such as eggs or ovalbumin;
Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Autoimmune disease or immunodeficiency
Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
Diabetes mellitus (type I or II), with the exception of gestational diabetes
History of thyroidectomy or thyroid disease that required medication within the past 12 months
Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
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
Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
Seizure disorder other than:
Febrile seizures under the age of two years old,
Seizures secondary to alcohol withdrawal more than 3 years ago, or
A singular seizure not requiring treatment within the last 3 years
Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
Guillain-Barre Syndrome
Women subjects with positive urinary pregnancy test
Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
History of any blood products administration within 3 months before the dosing
Administration of any other investigational research agents within 30 days before the dosing
Administration of any live attenuated vaccine within 30 days before the dosing
Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
Be receiving anti-TB prophylaxis or therapy currently
Axillary temperature >37.0 centigrade at the time of dosing
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Wu
Organizational Affiliation
Beijing Centers for Diseases Control and Prevention
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19281330
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine
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