Immunogenicity Study of S-OIV H1N1 Influenza Vaccine

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: Unknown
• Conditions: Human Influenza
• Intervention / Treatment: Biological: split-virion, H1N1 vaccine of 15 μg

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: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Assess the immunity level of the subjects before vaccination.	hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.	On Day 0 after first vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the immunity level of the subjects 10 days after 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	hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.	On Day 21 after first vaccination
Assess the immunity level of the subjects 28 days after 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	hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.	On Day 35 after first vaccination
Assess the immunity level of the subjects 42 days after vaccination	hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.	On Day 42 after first vaccination

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Jiangsu Province Centers for Disease Control and Prevention; Hualan Biological Bacterin Co. Ltd.
• Investigators: 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

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ANTICIPATED): April 1, 2010
• Study Completion (ANTICIPATED): August 1, 2010

Study Registration Dates

• First Submitted: March 29, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (ESTIMATE): March 31, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 12, 2010
• Last Update Submitted That Met QC Criteria: April 9, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: vaccine; T-cell response; the antibody response; S-OIV; Immunogenicity assessment
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Immunity_S-OIV_A/H1N1_vaccine