A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
November 9, 2016 updated by: Eli Lilly and Company
Vaccination Response Following Administration of Ixekizumab to Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Covance
-
-
Indiana
-
Evansville, Indiana, United States, 47710
- Covance
-
-
Texas
-
Dallas, Texas, United States, 75247
- Covance
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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- Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
Administered by SQ injection
Other Names:
Administered by IM injection
Other Names:
Administered by IM injection
Other Names:
|
|
Other: Boostrix® + Pneumovax®23
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
|
Administered by IM injection
Other Names:
Administered by IM injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 4, 2015
First Submitted That Met QC Criteria
September 4, 2015
First Posted (Estimate)
September 7, 2015
Study Record Updates
Last Update Posted (Estimate)
January 6, 2017
Last Update Submitted That Met QC Criteria
November 9, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16202
- I1F-MC-RHCA (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.