Phase 1
Completed N=84
A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02543918 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations — 52.6; 51.2; 89.5; 90.2 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations |
52.6; 51.2; 89.5; 90.2 | — |
Eligibility Criteria
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- Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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
Data sourced from ClinicalTrials.gov (NCT02543918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.