Immunogenicity Study of S-OIV H1N1 Influenza Vaccine

April 9, 2010 updated by: Chinese Academy of Sciences

Study of Humoral and Cellular Immunogenicity of Split-vaccine to Swine-origin H1N1 Influenza

The primary immunogenicity objective is to assess the antibody response and T-cell response of split-virion inactivated A (H1N1) vaccine. Participants will include up to 20 healthy persons of age 20 and older who have no history of novel influenza H1N1 2009 infection in latest 3 months or novel influenza H1N1 2009 vaccination. This is a randomized study in healthy males and non-pregnant females, aged 20 years and older. All subjects will be stratified into 1 dose group (15mcg per dose), and will receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. On Day 0, Day 10, Day 21, Day 28, Day 35 and Day 42 after first vaccination (Day 0), the immunogenicity testing will be manipulated. The antibody response of immunogenicity testing will be hemagglutination inhibiting (HAI) on serum. The T-cell response will be interferon-gamma ELISPOT assay and Tetramer staining using PBMCs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In 2009, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in North America. It rapidly spread to many countries around the world, which soon meets the World Health Organization (WHO) criteria for a pandemic. Data from several clinical trails with the split-virion inactivated S-OIV vaccine suggest that the vaccine stimulated strong specific antibody against S-OIV. However, the is no T-cell response data after the vaccination. In addition, we do not know S-OIV specific cellular immunity level of the population. These facts indicate the need to assess both the antibody response and T-cell response after the vaccination of the split-virion inactivated S-OIV vaccine. The primary immunogenicity objective is to assess the antibody response and T-cell response of split-virion inactivated A (H1N1) vaccine. Participants will contain only one age group, including up to 20 healthy persons of age 20 and older who have no history of novel influenza H1N1 2009 infection in latest 3 months or novel influenza H1N1 2009 vaccination. This is a randomized study in healthy males and non-pregnant females. All subjects will be stratified into 1 dose group (15mcg per dose), and will receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. On Day 0, Day 10, Day 21, Day 28, Day 35 and Day 42 after first vaccination (Day 0), the immunogenicity testing will be manipulated. The antibody response of immunogenicity testing will be hemagglutination inhibiting (HAI) on serum. The T-cell response will be interferon-gamma ELISPOT assay and Tetramer staining using PBMCs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100101
        • Institute of microbiology, Chinese Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy Volunteers of age 20 and older who have no history of novel influenza H1N1 2009 infection in latest 3 months or novel influenza H1N1 2009 vaccination.

Description

Inclusion Criteria:

  1. Healthy male or female aged 20 and older
  2. Be able to show legal identity card for the sake of recruitment
  3. Volunteers or their guardians are able to understand and sign the informed consent

Exclusion Criteria:

  1. Cases, cured cases and close contact of influenza A (H1N1) virus
  2. Women of pregnancy, lactation or about to be pregnant in 60 days
  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. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Autoimmune disease or immunodeficiency
  6. 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
  7. Diabetes mellitus (type I or II), with the exception of gestational diabetes
  8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  10. 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
  11. 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

  12. 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
  13. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  14. Guillain-Barre Syndrome
  15. 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)
  16. History of any blood products or swine-origin H1N1 or seasonal influenza vaccine administration within 3 months before the dosing
  17. Administration of any other investigational research agents within 30 days before the dosing
  18. Administration of any live attenuated vaccine within 30 days before the dosing
  19. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  20. Be receiving anti-TB prophylaxis or therapy currently
  21. Axillary temperature > 37.0 centigrade at the time of dosing

  22. 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
    • Suicidal ideation occurring within five years prior to enrollment
  23. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
vaccinated group
Biological: split-virion, H1N1 vaccine of 15 μg
split-virion inactivated S-OIV vaccine of 15 μg on day 0 and 21.
Other Names:
  • S-OIV vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the immunity level of the subjects before vaccination.
Time Frame: On Day 0 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
On Day 0 after first vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess the immunity level of the subjects 10 days after vaccination
Time Frame: On Day 10 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
On Day 10 after first vaccination
Assess the immunity level of the subjects 21 days after vaccination
Time Frame: On Day 21 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
On Day 21 after first vaccination
Assess the immunity level of the subjects 28 days after vaccination
Time Frame: On Day 28 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
On Day 28 after first vaccination
Assess the immunity level of the subjects 35 days after vaccination
Time Frame: On Day 35 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
On Day 35 after first vaccination
Assess the immunity level of the subjects 42 days after vaccination
Time Frame: On Day 42 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
On Day 42 after first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu Province Centers for Disease Control and Prevention
Hualan Biological Bacterin Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George Fu Gao, Ph.D., CAS Key Laboratory of Pathogenic Microbiology and Immunology,Institute of microbiology, Chinese Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Immunity_S-OIV_A/H1N1_vaccine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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