Human InfluenzaNCT01096225
Immunogenicity Study of S-OIV H1N1 Influenza Vaccine
An observational study of Human Influenza, run by Chinese Academy of Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- split-virion, H1N1 vaccine of 15 μg
- Type of treatment
- Vaccines
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome
- 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 or swine-origin H1N1 or seasonal influenza vaccine 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
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of microbiology, Chinese Academy of Sciences
Beijing, Beijing Municipality, 100101
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Influenza
- Being tested
- split-virion, H1N1 vaccine of 15 μg
- Keywords
- the antibody response, T-cell response, S-OIV, vaccine, Immunogenicity assessment
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-virion, H1N1 vaccine of 15 μgBiological
Also called S-OIV vaccine
split-virion inactivated S-OIV vaccine of 15 μg on day 0 and 21.
| Study group | Role | What they receive |
|---|---|---|
| vaccinated group | Not described Receives: Biological: split-virion, H1N1 vaccine of 15 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the immunity level of the subjects before vaccination.
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
Measured: On Day 0 after first vaccination
Secondary outcomes (5)
Assess the immunity level of the subjects 10 days after vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
Measured: On Day 10 after first vaccination
Assess the immunity level of the subjects 21 days after vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
Measured: On Day 21 after first vaccination
Assess the immunity level of the subjects 28 days after vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
Measured: On Day 28 after first vaccination
Assess the immunity level of the subjects 35 days after vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
Measured: On Day 35 after first vaccination
Assess the immunity level of the subjects 42 days after vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
Measured: On Day 42 after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Hualan Biological Bacterin Co. Ltd., Jiangsu Province Centers for Disease Control and Prevention
- Investigators
- George Fu Gao, Ph.D., Principal investigator, CAS Key Laboratory of Pathogenic Microbiology and Immunology,Institute of microbiology, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096225
- Sponsor's protocol ID
- Immunity_S-OIV_A/H1N1_vaccine
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Humoral and Cellular Immunogenicity of Split-vaccine to Swine-origin H1N1 Influenza
- ClinicalTrials.gov ID
- NCT01096225
- Acronym / sponsor ID
- Immunity_S-OIV_A/H1N1_vaccine
- Conditions
- Human Influenza
- Keywords
- the antibody response, T-cell response, S-OIV, vaccine, Immunogenicity assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Hualan Biological Bacterin Co. Ltd., Jiangsu Province Centers for Disease Control and Prevention
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccinated group | – | Biological: split-virion, H1N1 vaccine of 15 μg |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| split-virion, H1N1 vaccine of 15 μgAlso: S-OIV vaccinesplit-virion inactivated S-OIV vaccine of 15 μg on day 0 and 21. | Biological | vaccinated group |
Primary outcome
Assess the immunity level of the subjects before vaccination.
Time frame: On Day 0 after first vaccination
hemagglutination inhibiting (HAI), ELISPOT and Tetramer staining.
5 secondary outcomes
Assess the immunity level of the subjects 10 days after vaccination
Time frame: 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
Assess the immunity level of the subjects 28 days after vaccination
Time frame: 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
Assess the immunity level of the subjects 42 days after vaccination
Time frame: On Day 42 after first vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Fu Gao, Ph.D. principal investigator
CAS Key Laboratory of Pathogenic Microbiology and Immunology,Institute of microbiology, Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Influenza, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the immunity level of the subjects before vaccination. (time frame: On Day 0 after first vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2010.