H5 Vaccine Alone or With Aluminum Hydroxide in Elderly 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 Elderly Adults
1 other identifier
interventional
600
1 country
7
Brief Summary
The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2006
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJune 3, 2013
September 1, 2008
1 year
February 16, 2006
May 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine.
Approximately day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine.
Approximately day 56.
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 28 days after receipt of the second dose of vaccine.
Approximately day 56.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Approximately day 56.
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).
Adverse events will be collected through 28 days following the 2nd dose of vaccine (day 56). Serious adverse events will be collected throughout the study through day 208.
Secondary Outcomes (3)
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Day 0, and at days 28, 56, and 208 after the first immunization.
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine.
Day 0, and at days 28, 56, and 208 after the first immunization.
GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine.
Day 0, and at days 28, 56, and 208 after the first immunization.
Study Arms (8)
2
EXPERIMENTAL120 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide.
3
EXPERIMENTAL60 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide.
4
EXPERIMENTAL60 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide.
8
EXPERIMENTAL60 subjects to receive 3.75 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide.
7
EXPERIMENTAL60 subjects to receive 3.75 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide.
1
EXPERIMENTAL120 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide.
5
EXPERIMENTAL60 subjects to receive 7.5 mcg of inactivated influenza A/H5N1 vaccine with aluminum hydroxide.
6
EXPERIMENTAL60 subjects to receive 7.5 mcg of inactivated influenza A/H5N1 vaccine without aluminum hydroxide.
Interventions
Inactivated monovalent subvirion influenza H5N1 vaccine. Supplied in 0.5 mL unit dose vials as a sterile solution for IM injection. Dosages: 45 mcg, 15 mcg, 7.5, mcg, or 3.75 mcg administered with or without aluminum hydroxide adjuvant on Days 0 and 28.
Eligibility Criteria
You may qualify if:
- Are ambulatory adults aged 65 and older
- Are in good health, as determined by vital signs (heart rate less than 100 bpm, blood pressure \[systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg\] oral temperature less than 100.0°F), 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
You may not qualify if:
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, aluminum hydroxide, and chicken protein).
- Have immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids ( \> 800 micrograms/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 enrollment in this study.
- Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment 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. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dose adjustment within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
- Have a history of severe reactions following immunization with influenza virus vaccines.
- Have an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 7- to 8-month study period.
- Have 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.
- Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Saint Louis University
St Louis, Missouri, 63104, United States
University of Rochester
Rochester, New York, 14642, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
Brady RC, Treanor JJ, Atmar RL, Keitel WA, Edelman R, Chen WH, Winokur P, Belshe R, Graham IL, Noah DL, Guo K, Hill H. Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults. Vaccine. 2009 Aug 13;27(37):5091-5. doi: 10.1016/j.vaccine.2009.06.057. Epub 2009 Jul 3.
PMID: 19577636RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2006
First Posted
February 20, 2006
Study Start
March 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
June 3, 2013
Record last verified: 2008-09