Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the safety and tolerability an investigational peanut vaccine study drug for adults with non-severe peanut allergies.
We want to see if the peanut vaccine study drug will train the immune system not to have an allergic reaction when the body comes in contact with peanut proteins.
Who can participate?
Adults, 18 to 55 years old, who:
- Have a physician-diagnosed, non-severe peanut allergy OR history of peanut allergy
- Have an average body weight with a body mass index (BMI) of between 18 and 32
- Are able to attend the up to 13 study visits which are scheduled Monday through Thursday, 8 am to 4 pm, over a period of 8 1/2 months
What will happen in the study?
If you qualify and you decide to participate, you will come to Cincinnati Children’s for up to 13 study visits over the next 8 ½ months. Visits will be scheduled Monday through Thursday between 8 am and 4 pm.
While you are in this research study, study staff will collect information from you and ask you to perform the following tests and procedures during 1 or more study visits:
- Demographic (personal) information: including date of birth, sex, race and ethnicity
- Medical history: including details of the peanut allergy and current medical condition
- Medication history: including current list of any medications for the peanut allergy
- Vital sign measurements: including height, weight, temperature, blood pressure and pulse rate
- Physical exam: including general appearance, eyes, ears, nose, throat, neck, lymph nodes, lungs, heart, abdomen, skin, arms, legs, gastrointestinal tract, respiratory tract, and mental status
- Spirometry: a lung function test to measure how much and how quickly air moves out of the lungs
- Blood samples: for routine lab and safety tests
- Urine samples: for routine lab, safety and pregnancy tests (if you are female)
- Skin prick test (SPT): a small amount of an allergen is placed under the surface of the skin (via a prick or scratch) and watched for an allergic reaction
- Double-blinded placebo-controlled food challenge (DBPCFC): 2 food challenges (1 with peanut and 1 without) during which you will eat increasing amounts of food every 30 minutes for a period of time (neither you nor your doctor will know if you are eating peanut or placebo)
- Electrocardiogram (ECG): measures the function of the heart
- Diary: you will record symptoms following a study drug dosing
You will first take part in 2 separate screening periods (up to 35 days before the study drug dosing) to determine if you can participate in the rest of this study. The screening 1 visit will take 3 hours and screening 2 visit will take 6 hours. The tests and procedures during the 2 screenings, which will last 3 hours and then 6 hours, include a skin prick test and food challenge.
If you are eligible to continue after the screenings, you will return to Cincinnati Children’s for your first study drug dosing visit. During this visit, you will be randomly assigned (by chance, like flipping a coin) into 1 of 3 different groups to receive either the active study drug or placebo. A placebo looks like the study drug but contains no active ingredient. Neither you nor study staff will know if you are receiving the active study drug or placebo but can find out in an emergency.
After randomization, depending on your assigned group, you will receive your first dose of study drug via intradermal (into the skin) injection or intramuscular (into a muscle) injection. You will need to stay at the clinic for about 2 hours after you receive the study drug dose until all tests, procedures and observations are completed. If you do not show any signs of any allergic symptoms or reactions, you will be able to go home. If the doctor feels you are showing signs, you will be asked to stay for additional observation.
You will return for 3 more study drug dosing visits, each 2 weeks apart and lasting about 3 to 4 hours (including dosing, observation, tests and procedures).
After each of your study drug dosing visits, you will be asked to record any allergic symptoms or reactions in a diary for 7 days. We will also contact you by phone 24 hours after each dose to see how you are feeling.
When your dosing visits are complete, you will be followed for an additional 6 months and have 4 follow-up visits, each lasting about 2.5 to 3 hours. The tests and procedures completed at these visits are to monitor you for safety and tolerability of the study drug you received during the dosing visits (you will not receive any more study drug).
Lastly, you will have 1 study completion visit lasting about 2.5 to 3 hours. This will be your last visit of the study. You will have more tests and procedures and will need to stay until everything is completed.
You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.