Immunogenicity Study of S-OIV H1N1 Influenza Vaccine

NCT01096225 | Unknown

• 1 other identifier: Immunity_S-OIV_A/H1N1_vaccine
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Influenza

Keywords

the antibody response; T-cell response; S-OIV; vaccine; Immunogenicity assessment

Outcome Measures

Primary Outcomes (1)

• Assess the immunity level of the subjects before vaccination.

  hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.

  On Day 0 after first vaccination

Secondary Outcomes (5)

• Assess the immunity level of the subjects 10 days after vaccination

  On Day 10 after first vaccination

• Assess the immunity level of the subjects 21 days after vaccination

  On Day 21 after first vaccination

• Assess the immunity level of the subjects 28 days after vaccination

  On Day 28 after first vaccination

• Assess the immunity level of the subjects 35 days after vaccination

  On Day 35 after first vaccination

• Assess the immunity level of the subjects 42 days after vaccination

  On Day 42 after first vaccination

Study Arms (1)

vaccinated group

Biological: split-virion, H1N1 vaccine of 15 μg

Interventions

split-virion, H1N1 vaccine of 15 μg BIOLOGICAL

split-virion inactivated S-OIV vaccine of 15 μg on day 0 and 21.

Also known as: S-OIV vaccine

vaccinated group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Cases, cured cases and close contact of influenza A (H1N1) virus
• Women of pregnancy, lactation or about to be pregnant in 60 days
• 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
• Serious 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
• 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

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Hualan Biological Bacterin Co. Ltd.: collaborator
• Jiangsu Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Institute of microbiology, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100101, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Peripheral Blood Mononuclear Cell (PBMC)

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• George Fu Gao, Ph.D.

  CAS Key Laboratory of Pathogenic Microbiology and Immunology,Institute of microbiology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 31, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 12, 2010

Record last verified: 2010-03

Locations

CN (1)