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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Boostrix®; Drug: Pneumovax®23; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02543918

I1F-MC-RHCA (Other Identifier)

16202

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Ixekizumab + Boostrix® + Pneumovax®23

Experimental group

Description:

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.

Treatment:

Drug: Ixekizumab

Drug: Pneumovax®23

Drug: Boostrix®

Boostrix® + Pneumovax®23

Other group

Description:

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

Treatment:

Drug: Pneumovax®23

Drug: Boostrix®