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

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance, Daytona Beach, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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

Treatment and study plan

Ixekizumab

Drug

Administered by SQ injection

Other names: LY2439821

Boostrix®

Drug

Administered by IM injection

Other names: Tetanus, diphtheria, acellular pertussis vaccine (Tdap)

Pneumovax®23

Drug

Administered by IM injection

Other names: Pneumococcal polysaccharide vaccine

Primary outcomes

Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Vaccination Response Following Administration of Ixekizumab to Healthy Subjects

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 7, 2015
Registry last updated: Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed