H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults

Completed · Phase 1/Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00294099

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

600

Starts

2006-03-01

Expected to finish

2007-03-01

Last updated by the study team

2013-06-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

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
• 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.

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).
• 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 any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia.
• Have a history of Guillain Barre syndrome.
• Have any condition that the investigator believes may interfere with successful completion of the study.

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• University of Maryland Baltimore — Baltimore, Maryland, United States
• Saint Louis University — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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