- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296634
H5 Vaccine Alone or With Adjuvant in Healthy Adults
A Phase I-II, Randomized, Controlled, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Baltimore
-
-
New York
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Rochester, New York, United States, 14642
- University of Rochester
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North Carolina
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Durham, North Carolina, United States, 27704
- Duke University Medical Center
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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:
- Are males or nonpregnant females between the ages of 18 and 49 years, inclusive.
- Agree to practice adequate contraception (i.e., barrier methods, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period if they are females of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year).
- Are in good health as determined by vital signs, medical history to ensure stable medical condition, and targeted physical examination based on medical history.
- Are able to understand and comply with planned study procedures.
- Provide written informed consent prior to initiation of any study procedures.
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.
Exclusion Criteria:
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, aluminum hydroxide, and chicken protein).
- Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed.).
- Have a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
- 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, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, 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.
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
- Have 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.).
- Have a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Have an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during the 7-month study period.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).
- Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Have a history of alcohol or drug abuse in the last 5 years.
- Planned to travel outside of the USA in the time between the first vaccination and 56 days following the first vaccination.
- Have a history of Guillain Barre syndrome.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
45 microgram dose Hemagglutinin (HA), 120 subjects receiving Aluminum hydroxide and 120 not receiving Aluminum hydroxide.
|
Aluminum hydroxide adjuvant at 1200 mcg/mL.
Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant.
All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection.
Vaccine with adjuvant is a turbid liquid whitish-grey in color.
Vaccine without adjuvant is essentially clear and slightly opalescent in color.
|
Experimental: 2
15 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide.
|
Aluminum hydroxide adjuvant at 1200 mcg/mL.
Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant.
All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection.
Vaccine with adjuvant is a turbid liquid whitish-grey in color.
Vaccine without adjuvant is essentially clear and slightly opalescent in color.
|
Experimental: 4
3.75 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide.
|
Aluminum hydroxide adjuvant at 1200 mcg/mL.
Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant.
All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection.
Vaccine with adjuvant is a turbid liquid whitish-grey in color.
Vaccine without adjuvant is essentially clear and slightly opalescent in color.
|
Experimental: 3
7.5 microgram dose HA, 60 subjects receiving Aluminum hydroxide and 60 not receiving Aluminum hydroxide.
|
Aluminum hydroxide adjuvant at 1200 mcg/mL.
Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant.
All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection.
Vaccine with adjuvant is a turbid liquid whitish-grey in color.
Vaccine without adjuvant is essentially clear and slightly opalescent in color.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Time Frame: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
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Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
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Proportion of subjects in each group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus.
Time Frame: 28 days following second dose of vaccine.
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28 days following second dose of vaccine.
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Proportion of subjects in each dose group achieving a serum Hemagglutination Inhibition (HAI) antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus.
Time Frame: 28 days following second dose of vaccine.
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28 days following second dose of vaccine.
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Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Time Frame: 28 days following second dose of vaccine.
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28 days following second dose of vaccine.
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Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Time Frame: 28 days after receipt of the second dose of vaccine.
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28 days after receipt of the second dose of vaccine.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Time Frame: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
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1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
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Geometric mean titer (GMT) and the frequency of 4-fold or greater increases in serum HAI antibody titers.
Time Frame: 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
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1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
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Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Time Frame: Blood samples for serum assays will be collected at day 0 and at days 28, 56, and 208 after the first immunization.
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Blood samples for serum assays will be collected at day 0 and at days 28, 56, and 208 after the first immunization.
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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
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Orthomyxoviridae Infections
- Influenza, Human
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Gastrointestinal Agents
- Adjuvants, Immunologic
- Antacids
- Aluminum Hydroxide
Other Study ID Numbers
- 05-0127
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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