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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Ixekizumab
Drug: Boostrix®
Drug: Pneumovax®23
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23
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Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.

Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.

Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
Period Title: Overall Study
Started 41 43
Received at Least 1 Dose of Study Drug 41 42
Completed 38 39
Not Completed 3 4
Reason Not Completed
Never treated             0             1
Lost to Follow-up             1             1
Withdrawal by Subject             1             1
Adverse Event             1             1
Arm/Group Title Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23 Total
Hide Arm/Group Description 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. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. Total of all reporting groups
Overall Number of Baseline Participants 41 43 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 43 participants 84 participants
43.5  (12.2) 39.5  (10.5) 41.4  (11.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 84 participants
Female
19
  46.3%
19
  44.2%
38
  45.2%
Male
22
  53.7%
24
  55.8%
46
  54.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 84 participants
Hispanic or Latino
7
  17.1%
8
  18.6%
15
  17.9%
Not Hispanic or Latino
34
  82.9%
35
  81.4%
69
  82.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 84 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  36.6%
17
  39.5%
32
  38.1%
White
24
  58.5%
25
  58.1%
49
  58.3%
More than one race
2
   4.9%
1
   2.3%
3
   3.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 43 participants 84 participants
41 43 84
1.Primary Outcome
Title Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations
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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
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Hide Analysis Population Description
All randomized participants who completed the study.
Arm/Group Title Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23
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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.
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
Overall Number of Participants Analyzed 38 41
Measure Type: Number
Unit of Measure: percentage of participants
Tetanus Vaccine Responders 52.6 51.2
Pneumococcal Vaccine Responders 89.5 90.2
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Statistical Analysis Overview Comparison Group Selection Ixekizumab + Boostrix® + Pneumovax®23, Boostrix® + Pneumovax®23
Comments Tetanus vaccine responders
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 90%
-16.6 to 19.2
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Ixekizumab + Boostrix® + Pneumovax®23, Boostrix® + Pneumovax®23
Comments Pneumococcal vaccine responders
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 90%
-12.9 to 11.0
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23
Hide Arm/Group Description 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. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
All-Cause Mortality
Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/42 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixekizumab + Boostrix® + Pneumovax®23 Boostrix® + Pneumovax®23
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/41 (2.44%)      0/42 (0.00%)    
Infections and infestations     
Vulvovaginal candidiasis  1  1/19 (5.26%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: (800) 545-5979
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 Submitted: September 4, 2015
First Posted: September 7, 2015
Results First Submitted: November 9, 2016
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017