Vaccination Response Following Administration of Ixekizumab to Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Ixekizumab
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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- •Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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
Arms & Interventions
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.
Intervention: Ixekizumab
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.
Intervention: Boostrix®
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.
Intervention: Pneumovax®23
Boostrix® + Pneumovax®23
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Intervention: Boostrix®
Boostrix® + Pneumovax®23
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Intervention: Pneumovax®23
Outcomes
Primary Outcomes
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.