InfluenzaPhase 2NCT00617331
H9 Priming Study in Healthy Adults
A Phase 2 study testing Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses is associated with better antibody (part of the immune system that fights infection) responses after vaccination with an A/H9N2 flu vaccine. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 2
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 38 years, inclusive, or 44-59 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (e.g., barrier method, abstinence, and licensed hormonal methods) from at least 30 days prior to enrollment and for at least 3 months after receipt of dose 2.
- Be in good health, as determined by vital signs (heart rate less than 100 beats per minute, blood pressure systolic less than or equal to 140 mm Hg and greater than or equal to 90 mm Hg; diastolic less than or equal to 90 mm Hg, oral temperature less than 100 degrees Fahrenheit), medical history and a targeted physical examination based on medical history. (Stable medical condition - no change in prescription medication, dose or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.)
- Able to understand and comply with planned study procedures.
- Provide informed consent prior to initiation of any study procedures and be available for all study visits.
Who cannot join
- Has a known allergy to eggs or other components of the vaccine including thimerosal.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is breast-feeding, or has the intention to become pregnant within 3 months of receipt of their second dose of vaccine.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
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- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
- Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to each vaccination in the study, or expects to receive an experimental agent during the 7-month study period.
- Prior receipt of influenza A/H9N2 vaccine, other than the present study.
- Is planning to enroll in another clinical trial at any time during the study period (approximately 7 months total).
- Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.
- Has a history of alcohol or drug abuse in the last 5 years.
- Has a history of Guillain-Barré syndrome.
- Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- Plan to travel outside of the USA in the time between the first vaccination and 56 days following the first vaccination.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Has any condition that the investigator believes may interfere with successful completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Clinical Trial Evaluating the Immunogenicity of an Inactivated Influenza A/H9N2 Vaccine Among Healthy Adults With and Without Prior Exposure to Influenza A/H2N2
The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses is associated with better antibody (part of the immune system that fights infection) responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to different strengths of the H9N2 flu vaccine. This information may guide vaccine development for this virus as well as other bird flu viruses that have infected humans. Study participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The assignment of vaccines to participants is governed by chance. Study procedures may include medical history, physical exam, and blood samples. Study participation duration is about 7 months.
Read the detailed description
Influenza A viruses have the potential to cause worldwide epidemics and/or pandemics resulting in significant morbidity and mortality. The goals of this study are to determine whether persons over 44 years of age (born before 1964) have evidence of priming to influenza A/H9N2 viruses as measured by responses to two different dosage levels of an A/H9N2 vaccine. Evidence of priming for persons born before 1964 has implications in pandemic preparedness planning in that such individuals may need only a single vaccination to induce immunity compared to persons who are not immunologically primed. This study will also explore the immunogenicity of two-dose regimen using a homologous A/H9N2 virus as an antigen for the hemagglutination inhibition assay (HAI) and neutralizing antibody assays. Approximately 120 healthy adults will be enrolled into this single-center, randomized, double-blind trial of subvirion inactivated influenza A/H9N2 (G9 variant) vaccine given by intramuscular (IM) injection. Subjects will be stratified by age, with 50 percent in each dosage group being between the ages of 18 and 38 inclusive and the other 50 percent being between the ages of 44 and 59 years, inclusive. Subjects will be randomized 1:1 to receive 2 doses one month apart of one of two dosages (7.5 micrograms or 30 micrograms) of A/chicken/Hong Kong/G9/97 subvirion vaccine. The subjects and staff responsible for assessing responses after vaccination will be blinded to the dosage level that is administered. All subjects will receive two doses of their assigned dosage level given by the IM route separated by approximately 28 days. Subjects will be observed in the clinic for approximately 20 minutes after vaccination. Subjects will maintain a memory aid recording oral temperature, and systemic and local adverse events for 7 days after each inoculation. They will return to clinic on day 8 after vaccination (window 8-10) for adverse event (AE) assessment, concomitant medication assessment, a targeted physical exam (if indicated), and review of memory aid. AE data will be captured Day 0 through Day 56. Serious adverse event (SAE) data will be captured from Day 0 through the end of the trial (7 months after the first dose of vaccine). Serum for immunogenicity evaluations will be obtained prior to the first vaccination, at Day 0, prior to the second vaccination, at Day 28 and at Day 56. The primary objective is to determine whether persons 44-59 years of age show evidence of immunologic priming to A/H9 virus compared to persons 18-38 years of age. The secondary objectives are to evaluate dose-related immunogenicity 4 weeks after each vaccination and to evaluate the safety and tolerability of the vaccine.
- Conditions
- Influenza
- Being tested
- Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine
- Keywords
- vaccine, priming, influenza, flu, A/H9N2
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subvirion inactivated influenza A/H9N2 (G9 variant) vaccineBiological
Inactivated subvirion influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine administered via intramuscular (IM) injection, dose 7.5 or 30 micrograms.
| Study group | Role | What they receive |
|---|---|---|
| Dose 7.5 mcg | Experimental | 7.5 micrograms of vaccine administered on Day 0 and Day 28. Receives: Biological: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine |
| Dose 30 mcg | Experimental | 30 micrograms of vaccine administered on Day 0 and Day 28. Receives: Biological: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of 4-fold or greater serum hemagglutination inhibition assay (HAI) and neutralizing antibody rises in both age groups to the homologous vaccine antigen.
Measured: 28 Days after the first vaccine dose.
Secondary outcomes (7)
Frequencies of 4-fold or greater increase in titer between pre- and post-immunization samples.
Measured: 28 days after the second vaccination (day 56).
Frequencies and severity of solicited and local and systemic adverse events in each vaccine dosage/age group.
Measured: 7 days after each inoculation.
Proportion of subjects in each age/vaccine dosage group that achieves an HAI titer of at least 32.
Measured: 28 days after each vaccination (Day 28, Day 56).
Frequencies and GMT of serum HAI and serum neutralizing antibody against a homologous A/H9N2 virus.
Measured: One month after each vaccination (Day 28, Day 56).
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids and periodic targeted physical assessment).
Measured: Duration of study.
Proportion of subjects in each group with serum HAI or neutralizing antibody to influenza A/H2N2 viruses and the frequency and magnitude of antibody responses.
Measured: Before and after vaccination.
Geometric mean titer (GMT) of serum HAI and serum neutralizing antibody against the influenza A/H9N2 virus.
Measured: One month after each vaccination (Day 28, Day 56).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617331
- Sponsor's protocol ID
- 06-0073
- Other IDs
- N01AI30039C, N01AI30039
- Status last verified
- Jul 2011
- First submitted
- 14 Feb 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Clinical Trial Evaluating the Immunogenicity of an Inactivated Influenza A/H9N2 Vaccine Among Healthy Adults With and Without Prior Exposure to Influenza A/H2N2
- ClinicalTrials.gov ID
- NCT00617331
- Acronym / sponsor ID
- 06-0073
- Conditions
- Influenza
- Keywords
- vaccine, priming, influenza, flu, A/H9N2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Feb 2008 (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 purpose of this research study is to determine whether prior exposure to A/H2N2 viruses is associated with better antibody (part of the immune system that fights infection) responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to different strengths of the H9N2 flu vaccine. This information may guide vaccine development for this virus as well as other bird flu viruses that have infected humans. Study participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The assignment of vaccines to participants is governed by chance. Study procedures may include medical history, physical exam, and blood samples. Study participation duration is about 7 months.
Detailed description
Influenza A viruses have the potential to cause worldwide epidemics and/or pandemics resulting in significant morbidity and mortality. The goals of this study are to determine whether persons over 44 years of age (born before 1964) have evidence of priming to influenza A/H9N2 viruses as measured by responses to two different dosage levels of an A/H9N2 vaccine. Evidence of priming for persons born before 1964 has implications in pandemic preparedness planning in that such individuals may need only a single vaccination to induce immunity compared to persons who are not immunologically primed. This study will also explore the immunogenicity of two-dose regimen using a homologous A/H9N2 virus as an antigen for the hemagglutination inhibition assay (HAI) and neutralizing antibody assays. Approximately 120 healthy adults will be enrolled into this single-center, randomized, double-blind trial of subvirion inactivated influenza A/H9N2 (G9 variant) vaccine given by intramuscular (IM) injection. Subjects will be stratified by age, with 50 percent in each dosage group being between the ages of 18 and 38 inclusive and the other 50 percent being between the ages of 44 and 59 years, inclusive. Subjects will be randomized 1:1 to receive 2 doses one month apart of one of two dosages (7.5 micrograms or 30 micrograms) of A/chicken/Hong Kong/G9/97 subvirion vaccine. The subjects and staff responsible for assessing responses after vaccination will be blinded to the dosage level that is administered. All subjects will receive two doses of their assigned dosage level given by the IM route separated by approximately 28 days. Subjects will be observed in the clinic for approximately 20 minutes after vaccination. Subjects will maintain a memory aid recording oral temperature, and systemic and local adverse events for 7 days after each inoculation. They will return to clinic on day 8 after vaccination (window 8-10) for adverse event (AE) assessment, concomitant medication assessment, a targeted physical exam (if indicated), and review of memory aid. AE data will be captured Day 0 through Day 56. Serious adverse event (SAE) data will be captured from Day 0 through the end of the trial (7 months after the first dose of vaccine). Serum for immunogenicity evaluations will be obtained prior to the first vaccination, at Day 0, prior to the second vaccination, at Day 28 and at Day 56. The primary objective is to determine whether persons 44-59 years of age show evidence of immunologic priming to A/H9 virus compared to persons 18-38 years of age. The secondary objectives are to evaluate dose-related immunogenicity 4 weeks after each vaccination and to evaluate the safety and tolerability of the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose 7.5 mcg | Experimental | Biological: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine7.5 micrograms of vaccine administered on Day 0 and Day 28. |
| Dose 30 mcg | Experimental | Biological: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine30 micrograms of vaccine administered on Day 0 and Day 28. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 38 years, inclusive, or 44-59 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (e.g., barrier method, abstinence, and licensed hormonal methods) from at least 30 days prior to enrollment and for at least 3 months after receipt of dose 2.
- Be in good health, as determined by vital signs (heart rate less than 100 beats per minute, blood pressure systolic less than or equal to 140 mm Hg and greater than or equal to 90 mm Hg; diastolic less than or equal to 90 mm Hg, oral temperature less than 100 degrees Fahrenheit), medical history and a targeted physical examination based on medical history. (Stable medical condition - no change in prescription medication, dose or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.)
- Able to understand and comply with planned study procedures.
- Provide informed consent prior to initiation of any study procedures and be available for all study visits.
Key exclusion criteria (22 listed)
- Has a known allergy to eggs or other components of the vaccine including thimerosal.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is breast-feeding, or has the intention to become pregnant within 3 months of receipt of their second dose of vaccine.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
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 |
|---|---|---|
| Subvirion inactivated influenza A/H9N2 (G9 variant) vaccineInactivated subvirion influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine administered via intramuscular (IM) injection, dose 7.5 or 30 micrograms. | Biological | Dose 30 mcg, Dose 7.5 mcg |
Primary outcome
Frequency of 4-fold or greater serum hemagglutination inhibition assay (HAI) and neutralizing antibody rises in both age groups to the homologous vaccine antigen.
Time frame: 28 Days after the first vaccine dose.
7 secondary outcomes
Frequencies of 4-fold or greater increase in titer between pre- and post-immunization samples.
Time frame: 28 days after the second vaccination (day 56).
Frequencies and severity of solicited and local and systemic adverse events in each vaccine dosage/age group.
Time frame: 7 days after each inoculation.
Proportion of subjects in each age/vaccine dosage group that achieves an HAI titer of at least 32.
Time frame: 28 days after each vaccination (Day 28, Day 56).
Frequencies and GMT of serum HAI and serum neutralizing antibody against a homologous A/H9N2 virus.
Time frame: One month after each vaccination (Day 28, Day 56).
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids and periodic targeted physical assessment).
Time frame: Duration of study.
Proportion of subjects in each group with serum HAI or neutralizing antibody to influenza A/H2N2 viruses and the frequency and magnitude of antibody responses.
Time frame: Before and after vaccination.
Geometric mean titer (GMT) of serum HAI and serum neutralizing antibody against the influenza A/H9N2 virus.
Time frame: One month after each vaccination (Day 28, Day 56).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 5 inclusion and 22 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: finished, as of the sponsor's last update on 22 Jul 2011. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of 4-fold or greater serum hemagglutination inhibition assay (HAI) and neutralizing antibody rises in both age groups to the homologous vaccine antigen. (time frame: 28 Days after the first vaccine dose.). 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 22 Jul 2011.