| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21205 |
| Conditions: |
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Food Hypersensitivity - Hypersensitivity - Immediate Hypersensitivity - Peanut Hypersensitivity |
| Purpose: |
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The purpose of this study is to evaluate the safety and side effects of a study product that
contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic
participants. This is a first in human study.
As of November 2009, this study is no longer recruiting healthy volunteers and will only be
recruiting individuals with peanut allergies.
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| Study summary: |
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Peanut allergy is a common ailment in the United States. Research suggests that the
prevalence of peanut allergy in the United States has doubled over the last 5 years.
Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick
access to self-injectable epinephrine. This study will evaluate the safety of a rectally
administered product, EMP-123, consisting of three recombinant modified peanut protein
antigens encapsulated within dead E. coli. E. coli is a common bacterium found in
everyone's colon. E. coli acts like a package to hold the modified peanut proteins.
EMP-123 is designed to act as an allergy vaccine with an eventual goal to induce tolerance
to the major peanut proteins responsible for peanut allergy.
This study will involve weekly dosing and for females, a pregnancy test will occur at 48
hours before the start of product administration and later during the study. The study will
involve two steps. Step 1 will enroll 5 healthy participants who will receive four
escalating doses of study product on a weekly basis. Participants will be monitored at the
clinic for 2 hours after receiving each dose of study product. Each dosing visit will be
followed with a phone interview to assess any adverse effects or symptoms. Participants in
Step 1 will maintain a home diary and record any symptoms that occur between visits. After
screening, Step 1 will consist of five study visits on Weeks 1, 2, 3, 4, and 8. Vital signs,
adverse event monitoring, and review of the home diary will occur at all visits. Breathing
tests will occur at most visits. Stool and urine collection will occur at Weeks 4 and 8. The
expected duration of Step 1 is 8 weeks.
If no safety concerns are identified at the conclusion of Step 1, 10 peanut-allergic
participants will be enrolled into the second phase of the study, Step 2.
Step 2 is expected to last 20 weeks. Participants in Step 2 will receive weekly dose
escalation of the study product for 10 weeks followed by administration every 2 weeks for 6
weeks. Participants will remain in the clinic for 2 hours after every dose is received.
Follow-up will then continue for 4 weeks after the conclusion of treatment. Each dosing
visit will be followed with a phone interview to assess any adverse effects or symptoms.
After screening, Step 2 will consist of 14 study visits. Vital signs, adverse event
monitoring, and a review of the home diary will occur at all visits. Breathing tests will
occur at most visits. A skin prick test and stool, blood, and urine collection will occur at
select visits.
As of November 2009, this study is no longer recruiting healthy volunteers and will only be
recruiting individuals with peanut allergies. |
| Criteria: |
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Inclusion Criteria:
- Available for the duration of the trial
- Ability to perform spirometry maneuvers
- Agree to use effective methods of contraception for the duration of the study
- For Step 1 participants, regular consumption of at least 5 grams of peanut at least
twice per month during the last 6 months prior to study entry
- For Step 2 participants, a convincing clinical history of peanut allergy and prick
skin test positive to peanut. More information on these criteria can be found in the
protocol.
Exclusion Criteria:
- History of any severe anaphylaxis
- Known allergy to hydroxypropyl methylcellulose, glycerol, or phenol
- Evidence of clinically significant immunosuppressive neurologic, cardiac, pulmonary,
hepatic, rheumatologic, autoimmune, or renal disease
- Laboratory evidence of liver or hematologic disease. Pre-existing history of
autoimmune or antibody mediated diseases. More information on this criterion can be
found in the protocol.
- Pre-existing history of autoimmune or antibody mediated diseases. More information on
this criterion can be found in the protocol.
- Any previous intubation due to allergies or asthma
- History of ischemic cardiovascular disease
- Uncontrolled hypertension
- Significant medical condition that, in the opinion of the investigator, would
interfere with the study
- Chronic diarrhea
- Inability to refrain from anal intercourse for the duration of the trial
- Use of rectal medications during the study
- Planned rectal procedures for the duration of the study
- History of rectal surgery or bleeding in the last 6 months prior to study entry
- History of proctitis in the last 6 months prior to study entry
- History of inflammatory bowel disease, celiac disease, or eosinophilic
esophagitis/gentroenteritis
- Participation in another investigational vaccine or drug trial within 30 days prior
to study or while the study is ongoing
- Medical, occupational, or family problems as a result of alcohol or illicit drug use
during the last 12 months prior to study entry
- FEV1 value less than 80% predicted
- Inability to discontinue antihistamines for skin testing
- Currently on any allergy immunotherapy
- Participation in any interventional study for the treatment of food allergy in the
past 12 months prior to study entry
- Poor control of persistent activation of atopic dermatitis
- Use of omalizumab or other non-traditional forms of allergen immunotherapy or
immunomodulatory therapy or biologic therapy within the past 12 months prior to study
entry
- Use of oral B-blockers, angiotensin-receptor blockers, or calcium channel blockers
- Use of immunosuppressive drugs within 30 days prior to study entry or while study is
ongoing
- Use of corticosteroids within 30 days prior to study entry
- Use of steroid medications. More information on this criterion can be found in the
protocol.
- History of serologic evidence of infection with HIV-1, HBV, or HCV
- Receipt of blood products within the past 6 months prior to study entry
- Inability to refrain from anal intercourse for the duration of the study
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the
investigator, would interfere with the study
- Pregnant or breastfeeding
Step 1 participants:
- History of any allergy to food, including peanut
- Serum peanut-specific IgE greater than .35 kUa/L at screening
- Prick skin test (PST) to peanut more than 3mm in diameter at screening
- History of asthma
Step 2 participants:
- Asthma that is more sever than mild intermittent asthma. More information on this
criterion can be found in the protocol.
- Treatment for asthma. More information on this criterion can be found in the
protocol. |
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| Study is available at: |
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Johns Hopkins Univeristy
Baltimore, MD 21205
United States
Primary Contact:
Sarah Driggers, RN
Phone: 410-502-1711 |
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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 23, 2011 |
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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