A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
Vaccination Response Following Administration of Ixekizumab to Healthy Subjects
2 other identifiers
interventional
84
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
January 6, 2017
CompletedJanuary 6, 2017
November 1, 2016
2 months
September 4, 2015
November 9, 2016
November 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Ixekizumab + Boostrix® + Pneumovax®23
EXPERIMENTALIxekizumab 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.
Boostrix® + Pneumovax®23
OTHERBoostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Interventions
Administered by SQ injection
Administered by IM injection
Administered by IM injection
Eligibility Criteria
You may qualify if:
- Healthy males and females without compromised immune system
- Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Covance
Daytona Beach, Florida, 32117, United States
Covance
Evansville, Indiana, 47710, United States
Covance
Dallas, Texas, 75247, United States
Related Publications (1)
Gomez EV, Bishop JL, Jackson K, Muram TM, Phillips D. Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants. BioDrugs. 2017 Dec;31(6):545-554. doi: 10.1007/s40259-017-0249-y.
PMID: 29116597DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
September 7, 2015
Study Start
September 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
January 6, 2017
Results First Posted
January 6, 2017
Record last verified: 2016-11