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HealthyPhase 1NCT02543918

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

A Phase 1 study testing Ixekizumab, Boostrix® and Pneumovax®23 in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ixekizumab, Boostrix® and Pneumovax®23
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
3 sitesUnited States
Study dates
Sep 2015to Dec 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males and females without compromised immune system
  • Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)

Who cannot join

  • Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists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
Show all 17Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Covance

    Dallas, Texas, 75247

  • Covance

    Daytona Beach, Florida, 32117

  • Covance

    Evansville, Indiana, 47710

Other trials in United States

About this study

Official title: 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.

Conditions
Healthy
Being tested
Ixekizumab, Boostrix®, Pneumovax®23

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxekizumabDrug

    Also called LY2439821

    Administered by SQ injection

  • Boostrix®Drug

    Also called Tetanus, diphtheria, acellular pertussis vaccine (Tdap)

    Administered by IM injection

  • Pneumovax®23Drug

    Also called Pneumococcal polysaccharide vaccine

    Administered by IM injection

Study groups in NCT02543918
Study groupRoleWhat they receive
Ixekizumab + Boostrix® + Pneumovax®23ExperimentalIxekizumab 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.
Receives: Drug: Ixekizumab; Drug: Boostrix®; Drug: Pneumovax®23
Boostrix® + Pneumovax®23OtherBoostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Receives: Drug: Boostrix®; Drug: Pneumovax®23

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionNov 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543918
Sponsor's protocol ID
16202
Other IDs
I1F-MC-RHCA
Status last verified
Nov 2016
First submitted
4 Sep 2015
Last updated
6 Jan 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 29116597

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixekizumab, Boostrix® and Pneumovax®23 in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.

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