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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02543918
• Collaborator: (none)
• Enrollment: 84
• Locations: 3
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 28
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Sep 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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 Names: LY2439821 ; Drug: Boostrix®; Administered by IM injection; Other Names: Tetanus, diphtheria, acellular pertussis vaccine (Tdap) ; Drug: Pneumovax®23; Administered by IM injection; Other Names: Pneumococcal polysaccharide vaccine
Other: 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 Names: Tetanus, diphtheria, acellular pertussis vaccine (Tdap) ; Drug: Pneumovax®23; Administered by IM injection; Other Names: Pneumococcal polysaccharide vaccine

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance	Daytona Beach	Florida	United States	32117
2	Covance	Evansville	Indiana	United States	47710
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02543918
• Other Study ID Numbers: 16202; I1F-MC-RHCA
• First Posted: Sep 7, 2015
• Last Update Posted: Jan 6, 2017
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ixekizumab; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	Ixekizumab + Boostrix® + Pneumovax®23	Boostrix® + Pneumovax®23
Arm/Group Description	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

Baseline Characteristics

Arm/Group Title	Ixekizumab + Boostrix® + Pneumovax®23	Boostrix® + Pneumovax®23	Total
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 Participants	41	43	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (12.2)	39.5 (10.5)	41.4 (11.5)
Gender (Count of Participants)
Female	19 46.3%	19 44.2%	38 45.2%
Male	22 53.7%	24 55.8%	46 54.8%
Ethnicity (NIH/OMB) (Count of 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%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
Region of Enrollment (participants) [Number]
United States	41 100%	43 100%	84 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations
Description	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

Outcome Measure Data

Analysis Population Description

All randomized participants who completed the study.

Arm/Group Title	Ixekizumab + Boostrix® + Pneumovax®23	Boostrix® + Pneumovax®23
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.
Measure Participants	38	41
Tetanus Vaccine Responders	52.6 128.3%	51.2 119.1%
Pneumococcal Vaccine Responders	89.5 218.3%	90.2 209.8%

Statistical Analysis 1

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.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 90%; -16.6 to 19.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

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.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 90%; -12.9 to 11.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ixekizumab + Boostrix® + Pneumovax®23		Boostrix® + Pneumovax®23
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Ixekizumab + Boostrix® + Pneumovax®23		Boostrix® + Pneumovax®23
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/41 (2.4%)		0/42 (0%)
Infections and infestations
Vulvovaginal candidiasis	1/19 (5.3%)	1	0/18 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.