Is your child allergic to peanuts?
A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
- Not accepting healthy volunteers
- UTSW Principal Investigator: John Andrew Bird, M.D.
summary
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.
eligibility
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.
For additional information about the study, visit clinicaltrials.gov.