Healthy
Conditions
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.
Interventions
DRUGIxekizumab
Administered by SQ injection
DRUGBoostrix®
Administered by IM injection
DRUGPneumovax®23
Administered by IM injection
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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* Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists * Have participated, within the last 30 days, in a clinical trial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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab + Boostrix® + Pneumovax®23 Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. | 41 |
| Boostrix® + Pneumovax®23 Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. | 43 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Never treated | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Ixekizumab + Boostrix® + Pneumovax®23 | Boostrix® + Pneumovax®23 | Total |
|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 12.2 | 39.5 years STANDARD_DEVIATION 10.5 | 41.4 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 35 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 19 Participants | 19 Participants | 38 Participants |
| Gender Male | 22 Participants | 24 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 17 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 25 Participants | 49 Participants |
| Region of Enrollment United States | 41 participants | 43 participants | 84 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 41 | 0 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 |
Outcome results
Primary
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.
Time frame: Week 6
Population: All randomized participants who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixekizumab + Boostrix® + Pneumovax®23 | Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | Tetanus Vaccine Responders | 52.6 percentage of participants |
| Ixekizumab + Boostrix® + Pneumovax®23 | Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | Pneumococcal Vaccine Responders | 89.5 percentage of participants |
| Boostrix® + Pneumovax®23 | Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | Tetanus Vaccine Responders | 51.2 percentage of participants |
| Boostrix® + Pneumovax®23 | Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | Pneumococcal Vaccine Responders | 90.2 percentage of participants |
Comparison: Tetanus vaccine responders90% CI: [-16.6, 19.2]
Comparison: Pneumococcal vaccine responders90% CI: [-12.9, 11]