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Immunogenicity Study of S-OIV H1N1 Influenza Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Chinese Academy of Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Hualan Biological Bacterin Co. Ltd
Jiangsu Province Centers for Disease Control and Prevention
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01096225
First received: March 29, 2010
Last updated: April 9, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Human Influenza
Biological: split-virion, H1N1 vaccine of 15 μg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Humoral and Cellular Immunogenicity of Split-vaccine to Swine-origin H1N1 Influenza

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • Assess the immunity level of the subjects before vaccination. [ Time Frame: On Day 0 after first vaccination ] [ Designated as safety issue: Yes ]
    hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.


Secondary Outcome Measures:
  • Assess the immunity level of the subjects 10 days after vaccination [ Time Frame: On Day 10 after first vaccination ] [ Designated as safety issue: Yes ]
    hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.

  • Assess the immunity level of the subjects 21 days after vaccination [ Time Frame: On Day 21 after first vaccination ] [ Designated as safety issue: Yes ]
    hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.

  • Assess the immunity level of the subjects 28 days after vaccination [ Time Frame: On Day 28 after first vaccination ] [ Designated as safety issue: Yes ]
    hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.

  • Assess the immunity level of the subjects 35 days after vaccination [ Time Frame: On Day 35 after first vaccination ] [ Designated as safety issue: Yes ]
    hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.

  • Assess the immunity level of the subjects 42 days after vaccination [ Time Frame: On Day 42 after first vaccination ] [ Designated as safety issue: Yes ]
    hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.


Biospecimen Retention:   Samples Without DNA

Serum Peripheral Blood Mononuclear Cell (PBMC)


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: S-OIV vaccine

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  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: NCT01096225

Locations
China, Beijing
Institute of microbiology, Chinese Academy of Sciences
Beijing, Beijing, China, 100101
Sponsors and Collaborators
Chinese Academy of Sciences
Hualan Biological Bacterin Co. Ltd
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Principal Investigator: George Fu Gao, Ph.D. CAS Key Laboratory of Pathogenic Microbiology and Immunology,Institute of microbiology, Chinese Academy of Sciences
  More Information

No publications provided

Responsible Party: Institute of Microbiology, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT01096225     History of Changes
Other Study ID Numbers: Immunity_S-OIV_A/H1N1_vaccine
Study First Received: March 29, 2010
Last Updated: April 9, 2010
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Sciences:
the antibody response
T-cell response
S-OIV
vaccine
Immunogenicity assessment

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

ClinicalTrials.gov processed this record on November 27, 2014