A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Ixekizumab; Vaccines

Criteria

Inclusion Criteria:

• Healthy males and females without compromised immune system

• Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

• Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists

• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed

• Have known allergy or hypersensitivity to any biologic therapy

• Past vaccination allergy or Arthus-type hypersensitivity

• Received a tetanus toxoid-containing vaccine within the last 5 years

• Severe allergic reaction to Boostrix

• Allergic to latex

• Have been immunized with pneumococcal vaccine

• Known hypogammaglobulinemia

• History of Guillain-Barre Syndrome

• Active infectious disease

• Had a live vaccination within 1 year prior to screening, or intend to have a live vaccination during the course of the study

• Evidence of a significant uncontrolled neuropsychiatric disorder -

• Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self Report (16 Items) at screening

• Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B

• Had symptomatic herpes zoster within 3 months of screening

• Women who are lactating