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View Clinical Trial (Medical Research Study)
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Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59 - NCT00912496-27704 (Clinical Trial 296309)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy296309.aspx
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| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27704 |
| Conditions: |
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Influenza |
| Purpose: |
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This research will study safety and the body's immune responses, including anti-H5 flu
antibodies (the body's protective proteins found in the blood), for an inactivated
influenza"H5" bird flu, virus vaccine. Participants will be assigned by chance to receive
the vaccine injections with and without an adjuvant, (substance that can improve vaccine
effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Four
different vaccine dose strengths will be evaluated. About 755 healthy participant, ages
18-49 will be asked to take part in this United States based study. Study procedures include
physical exam, blood sampling, and use of a memory aid. All volunteers will participate for
about 7 months.
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| Study summary: |
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This study is designed to gather critical information on the safety, tolerability, and
immunogenicity of booster vaccination with influenza A/Anhui/05 with and without the
adjuvant MF59 in subjects previously primed with the clade 1 vaccine or unprimed
individuals. Primary objectives are: to evaluate booster vaccination with a different
variant/clade of A/Anhui/05 vaccine to assess possible prime for a broad immune response by
1 or 2 previous doses of A/Vietnam/1203/04; to compare 1-dose versus 2-dose priming of
A/Vietnam/1203/04 followed by heterologous boosting with A/Anhui/05; to assess the safety of
MF59 adjuvanted A/Anhui/05 vaccine in primed subjects; and to compare safety and
immunogenicity of 1 and 2 doses of A/Anhui/05 with or without MF59 adjuvant, or to saline
placebo, in a Phase I dose response study in naïve subjects. Up to 200 healthy adult
subjects aged 18 through 49 who were previously enrolled in Division of Microbiology and
Infectious Diseases (DMID) 07-0019 and received either 1 or 2 priming doses of
A/Vietnam/1203/04 H5 influenza vaccine will be enrolled in this study. Additionally,
approximately 555 healthy adult subjects aged 18 through 49 H5 vaccine naïve will be
recruited to receive 2 doses, 1 month apart, of A/Anhui/05 vaccine with or without MF59
adjuvant or placebo. Entry criteria for the newly enrolled subjects will be the same as
those used in DMID 07-0019. Because extensive safety data were collected for similar H5
vaccines, subjects will not be screened with clinical laboratory tests, and safety labs will
not be part of the evaluation process. The booster for Groups 8-9 will be randomized to 1 of
5 possible doses, with approximately 20 subjects per Group (allocation ratio 1:1:1:1:1) in
each dose assignment: 3.75 micrograms (mcg) MF59, 7.5 mcg MF59, 15.0 mcg MF59, 15.0 mcg or
90 mcg. Newly enrolled, vaccine naïve subjects in Group 10 will be randomized to 1 of 9
possible dosages with or without MF59 adjuvant, with approximately 50 subjects in each
dosage assignment: 3.75 mcg MF59, 3.75 mcg, 7.5 mcg MF59, 7.5 mcg, 15.0 mcg MF59, 15.0 mcg,
45.0 mcg MF59, 45.0 mcg, 90 mcg, or saline placebo with 3 groups of 35 subjects each,
receiving different volumes of: one injection of 0.5 mL, one injection of 0.75 mL or 2
injections of 0.75 mL, for comparison. Volunteers will be observed in the clinic for at
least 15 minutes after vaccination, and will maintain a Memory Aid to record oral
temperature and systemic and local adverse events (AEs) and serious adverse events (SAEs)
for 8 days after vaccination. Volunteers will be contacted by telephone 1 to 3 days after
vaccination (approximately Day 2 post dose) to assess for the occurrence of AEs/SAEs, and
they will return to the clinic 7 to 9 days after vaccination (approximately Day 8 post dose)
for AE/SAE and concomitant medication assessment, a targeted physical examination (if
indicated), and review of the Memory Aid. Volunteers in Group 10 will return to clinic on
Day 28 for review of eligibility criteria to receive Dose Number 2 of A/Anhui/05 or placebo.
Volunteers in this group will then follow the same study schedule as following the first
vaccination. All subjects will continue to be followed for 6 months after the last
vaccination. It is anticipated that this study will enroll approximately 755 subjects over
10-14 weeks. This study is linked to DMID protocol 07-0019. |
| Criteria: |
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Inclusion Criteria:
- Men and women, 18 through 49 years old, who either were previously enrolled and
received all scheduled vaccinations in Groups 8 and 9 under Division of Microbiology
and Infectious Diseases (DMID) 07-0019, or are new subjects who deny exposure to H5
virus or participation in an H5 vaccine study.
- In good health, as determined by vital signs (heart rate <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 <100.0 degrees
Fahrenheit), medical history to ensure stable medical condition and a targeted
physical examination, as indicated, 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.)
- Women of childbearing potential (not surgically sterile or postmenopausal for greater
than or equal to 1 year) must not be pregnant as indicated by a negative pregnancy
test (urine or serum) within 24 hours prior to vaccine administration.
- Women of childbearing potential who are at risk of becoming pregnant must have a
history of practicing adequate contraception (i.e., barrier methods, abstinence,
monogamous relationship with vasectomized partner, intrauterine devices,
Depo-Provera, Norplant, oral contraceptives, contraceptive patches or other licensed,
effective methods) in the 30 days prior to enrollment, and must agree to practice
adequate contraception until 30 days following receipt of the last dose of vaccine.
- Able to understand and comply with planned study procedures.
- Able to provide informed consent prior to initiation of any study procedures and be
available for all study visits.
Exclusion Criteria:
- Has occupational exposure to poultry, to include but is not limited to chicken,
turkey, or duck farmer, factory worker in poultry processing plant, veterinary staff
that handles poultry; has recreational exposure to poultry, e.g. raising poultry in
4-H club, duck hunter that slaughters/handles the "kill" or history of previous H5N1
vaccination or exposure (other than vaccination in Protocol 07-0019).
- Has a known allergy to egg proteins (egg or egg products), or other components of the
vaccine (including thimerosal, polymyxin, neomycin, beta propiolactone, or
nonylphenol ethoxylate).
- Is female of child-bearing potential who is breastfeeding or intends to become
pregnant during the study period up to 30 days following receipt of the last dose of
vaccine.
- Has immunosuppression as a result of an underlying illness or treatment with
immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
therapy within the preceding 36 months.
- Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate
cancer that is stable in the absence of therapy) or a history of any hematologic
malignancy. An active neoplastic disease is defined as no neoplastic disease or
treatment for neoplastic disease within the past 5 years.
- Has long-term use (> than 2 weeks) of oral or parenteral steroids (glucocorticoids),
or high-dose inhaled steroids (>800 micrograms/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 products within the 3 months
prior to enrollment in this study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrollment in this study, or plans to receive
any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for
live vaccines) following each study vaccine.
- Has an acute or chronic medical condition that would render vaccination unsafe or
would interfere with the evaluation of responses. This includes, but is not limited
to: solicited reactogenicity symptoms, known chronic liver disease, significant renal
disease, unstable or progressive neurological disorders, diabetes mellitus, and
transplant recipients.
- Has a history of severe reactions following vaccination with contemporary influenza
virus vaccines.
- Has an acute illness or has an oral temperature greater than 99.9 degrees Fahrenheit
(37.7 degrees Celsius) within 3 days prior to enrollment.
- Has 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 study period.
- Has any condition that would, in the opinion of the site principal investigator place
the subject at an unacceptable risk of injury or render the subject unable to meet
the requirements of the protocol.
- Has a diagnosis of schizophrenia, bipolar disease or other severe (disabling) chronic
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 decompensating
are allowed enrollment into the study.
- Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Has a history of alcohol or drug abuse in the 5 years prior to enrollment.
- Has a history of Guillain-Barré syndrome.
- Has any condition that the investigator believes may interfere with successful
completion of the study.
- Plans to enroll in another clinical trial (that has a study intervention in the form
of drug, biologic or device that could interfere with safety assessment of H5N1
vaccine) at any time during the study period. |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27704
United States
Primary Contact:
Robert B Belshe
Phone: (314) 577-8646 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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