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

Study Overview
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Brief Summary
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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.

Official Title
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Vaccination Response Following Administration of Ixekizumab to Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ixekizumab
* Drug: Boostrix®
* Drug: Pneumovax®23


Participation Criteria
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Eligibility Criteria
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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Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²) Exclusion Criteria: Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists Have participated, within the last 30 days, in a clinical trial involving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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ixekizumab + Boostrix® + Pneumovax®23<br>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. | Drug: Ixekizumab<br>* Administered by SQ injection<br>* Other names: LY2439821;Drug: Boostrix®<br>* Administered by IM injection<br>* Other names: Tetanus, diphtheria, acellular pertussis vaccine (Tdap);Drug: Pneumovax®23<br>* Administered by IM injection<br>* Other names: Pneumococcal polysaccharide vaccine;|
| Other: Boostrix® + Pneumovax®23<br>Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. | Drug: Boostrix®<br>* Administered by IM injection<br>* Other names: Tetanus, diphtheria, acellular pertussis vaccine (Tdap);Drug: Pneumovax®23<br>* Administered by IM injection<br>* Other names: Pneumococcal polysaccharide vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | 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. | Week 6 |