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

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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

Arm && Interventions

Group	Intervention	Description
Ixekizumab + Boostrix® + Pneumovax®23	Boostrix®	Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
Boostrix® + Pneumovax®23	Boostrix®	Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Boostrix® + Pneumovax®23	Pneumovax®23	Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Ixekizumab + Boostrix® + Pneumovax®23	Pneumovax®23	Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
Ixekizumab + Boostrix® + Pneumovax®23	Ixekizumab	Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations	Week 6	Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of \>=1.0 (International Unit (IU) and a \>=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is \<=1.0 at baseline OR a \>=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is \> 1.0 IU at baseline. Responder to the pneumococcal vaccine is defined as a \>=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against \>50% of the 23 serotypes.

Secondary Outcome Measures