Children’s Health℠ is conducting a clinical research study that is currently looking for children ages 12 to 17 who are allergic to peanuts to test an investigational vaccine. We are evaluating the safety and tolerability of an investigational intradermal (ID) vaccine for peanut allergy. This is a phase one study, which is the earliest phase in a clinical trial development. Phase one trials focus on the safety and dosage of investigational drugs.
Why it is important? The prevalence of peanut allergy is increasing and it is important to do research evaluating treatment options. Currently, there are no recommended drugs to prevent food-induced allergic reactions. Strict avoidance of the allergen is the current recommendation.
What do we hope to accomplish? Evaluate the safety, tolerability, and immune response of an investigational intradermal (ID) vaccine for peanut allergy.
Who can participate? (Additional criteria to be met prior to participation)
Adolescents between ages 12-17 years old
Adolescents that have a peanut allergy that has been diagnosed by a doctor or has a history of peanut allergies
Adolescents who are willing to receive an investigational intradermal (ID) vaccine for peanut allergy and are willing to participate for about 9 months (about 13 visits)
Who cannot participate? (Additional exclusion criteria to be reviewed prior to participation)
Those who are pregnant or breastfeeding
Those who have an immune disorder
Those who are Hepatitis B, Hepatitis C or HIV positive
What will you be asked to do? Participants will be asked to come into the Food Allergy Center to receive 4 injections of the investigational peanut vaccine or placebo. There is a 4:1 chance of receiving peanut vs placebo. The remaining visits will be for safety follow-up after injection. Other assessments include vital signs, blood draws, skin prick testing, lung function testing, physical examinations, food challenges, and EKG.