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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ixekizumab + Boostrix® + 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.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered by SQ injection

Boostrix®

Intervention Type DRUG

Administered by IM injection

Pneumovax®23

Intervention Type DRUG

Administered by IM injection

Boostrix® + Pneumovax®23

Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.

Group Type OTHER

Boostrix®

Intervention Type DRUG

Administered by IM injection

Pneumovax®23

Intervention Type DRUG

Administered by IM injection

Interventions

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Ixekizumab

Administered by SQ injection

Intervention Type DRUG

Boostrix®

Administered by IM injection

Intervention Type DRUG

Pneumovax®23

Administered by IM injection

Intervention Type DRUG

Other Intervention Names

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LY2439821 Tetanus, diphtheria, acellular pertussis vaccine (Tdap) Pneumococcal polysaccharide vaccine

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes