- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439335
Higher Dose Intradermal H5 Vaccine
A Phase I/II Randomized, Double-Blinded Placebo-Controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Subvirion Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or non-pregnant female between the ages of 18 and 49 years, inclusive.
- Women of childbearing potential (not surgically sterile or post menopausal for greater than or equal to 1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine devices, or licensed hormonal methods) for the entire study period.
- Is 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 100.0 degrees Fahrenheit), medical history to ensure stable medical condition (see definition below) and a targeted physical examination based on medical history.
Stable medical condition - no recent 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 is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedures.
Exclusion Criteria:
- Has a known allergy to eggs or other components of the vaccine.
- Has a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential), is breastfeeding, or has the intention to become pregnant during the study period.
- Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Long term use of oral or parenteral steroids, high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Has a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
- Has been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Is 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 are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination 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 a moderate to severe acute illness and/or an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
- Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- History of alcohol or drug abuse in the 5 years prior to enrollment.
- Presence of any active skin disease on upper arms that could impact study product delivery or site assessment.
- Has a history of Guillain Barre syndrome.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent during the 7-month study period.
- Participated in an Influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).
- Is enrolled or planning to enroll in another interventional trial at any time between receipt of the first dose of vaccine and the end of the study (approximately 7 months after receipt of the first dose).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: H5 HA IM
Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
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Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection.
Vaccine will be administered to each subject at Days 0 and 28.
Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intradermal (ID) injection.
Vaccine will be administered to each subject at Days 0 and 28.
The placebo will be 0.1 mL of saline administered by the ID route.
|
Experimental: H5 HA ID
Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
|
Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection.
Vaccine will be administered to each subject at Days 0 and 28.
Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intradermal (ID) injection.
Vaccine will be administered to each subject at Days 0 and 28.
The placebo will be 0.1 mL of saline administered by the IM route.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2
Time Frame: Approximately Day 56.
|
Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine
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Approximately Day 56.
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Number of Participants Spontaneously Reporting Any Serious Adverse Event.
Time Frame: Through Day 208.
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Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.
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Through Day 208.
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Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.
Time Frame: Through approximately Day 56
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The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination.
Participants are counted only once but may have experienced events on multiple occasions.
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Through approximately Day 56
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Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.
Time Frame: 7 days after each vaccination
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The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea.
Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.
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7 days after each vaccination
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Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.
Time Frame: 7 days after each vaccination
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The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation.
Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.
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7 days after each vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HAI Geometric Mean Titer (GMT) After Dose 2
Time Frame: Approximately Day 56.
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HAI geometric mean titer (GMT) against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine.
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Approximately Day 56.
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Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2
Time Frame: Approximately Day 56
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Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine
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Approximately Day 56
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Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.
Time Frame: Approximately Day 28
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Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose.
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Approximately Day 28
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HAI GMT After Dose 1
Time Frame: Approximately Day 28
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HAI GMT against influenza A/H5N1 virus one month after receipt of the first dose of vaccine.
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Approximately Day 28
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Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.
Time Frame: Approximately Day 28
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Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose of vaccine.
|
Approximately Day 28
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Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.
Time Frame: Approximately Day 208
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Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.
|
Approximately Day 208
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HAI GMT at 7 Months After Dose 1
Time Frame: Approximately Day 208
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HAI GMT against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.
|
Approximately Day 208
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Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.
Time Frame: Approximately Day 208
|
Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 7 months after receipt of the first dose of vaccine.
|
Approximately Day 208
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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