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Trial record 27 of 29 for:    LY2439821

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

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ClinicalTrials.gov Identifier: NCT02543918
Recruitment Status : Completed
First Posted : September 7, 2015
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ixekizumab Drug: Boostrix® Drug: Pneumovax®23 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vaccination Response Following Administration of Ixekizumab to Healthy Subjects
Study Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

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.

Drug: Ixekizumab
Administered by SQ injection
Other Name: LY2439821

Drug: Boostrix®
Administered by IM injection
Other Name: Tetanus, diphtheria, acellular pertussis vaccine (Tdap)

Drug: Pneumovax®23
Administered by IM injection
Other Name: Pneumococcal polysaccharide vaccine

Boostrix® + Pneumovax®23
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Drug: Boostrix®
Administered by IM injection
Other Name: Tetanus, diphtheria, acellular pertussis vaccine (Tdap)

Drug: Pneumovax®23
Administered by IM injection
Other Name: Pneumococcal polysaccharide vaccine




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543918


Locations
United States, Florida
Covance
Daytona Beach, Florida, United States, 32117
United States, Indiana
Covance
Evansville, Indiana, United States, 47710
United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02543918     History of Changes
Other Study ID Numbers: 16202
I1F-MC-RHCA ( Other Identifier: Eli Lilly and Company )
First Posted: September 7, 2015    Key Record Dates
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Ixekizumab
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents