Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01733056
• Collaborator: (none)
• Enrollment: 43
• Locations: 2
• Arms: 3
• Duration (Months): 24
• Patients Per Site: 21.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto

1. Problem of Interest We are proposing to study the effectiveness of vaccines in people who are taking drugs that affect the immune system. There are many populations of people who have chronic medical conditions that require them to have long-term treatment with immunosuppressive medications (drugs that decrease the function of the immune system). Examples of these patients include organ transplant recipients, patients with immune cell cancers such as leukemia and lymphoma, patients with inflammatory disorders such as lupus or scleroderma, and patients with skin conditions requiring steroid-based creams, ointments, pills, or injections. Patients who are taking these medications should receive appropriate vaccinations such as tetanus boosters, influenza vaccines, and pneumonia vaccines. The effectiveness of vaccinations depends in large part on a strong response to the vaccine by the immune system. Drugs that decrease immune system function therefore, may also decrease the effectiveness of vaccines.

2. How the Problem of Interest will be studied

We plan to give three different groups of participants influenza vaccinations and measure each participant's immune system response through blood tests. The three groups will be:

1. Healthy people taking no immunosuppressive medications

2. Patients with skin conditions requiring treatment with azathioprine and currently taking no other immunosuppressive agents

3. Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis factor-alpha) and currently taking no other immunosuppressive medications.

All participants will be between 18 - 89 years old and will not have had influenza vaccination within the previous six months. We will administer the vaccination on day 0. We will take blood samples on days 0, 7, and 28 following vaccination. We will use these blood samples to measure the amount of antibodies produced to the vaccine and the response of specific immune system cells known as B-lymphocytes. Using statistical methods, we will compare these findings between the three groups of participants to determine if differences in response to the vaccination exist.

1. How the research will advance scientific knowledge and/or human health To our knowledge there is no scientific data available regarding the effectiveness of vaccinations in patients receiving only one specific immunosuppressive medication. We will also be using new techniques developed at Emory to measure the B-lymphocyte response to the vaccine. This research could potentially help guide vaccination strategies for people requiring immunosuppressive medications and prevent infectious disease in these populations as well as the general population.

Condition or Disease	Intervention/Treatment	Phase
Immunosuppression	Biological: Flu Vaccine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Characterization of Immune Response to Vaccination in Patients Receiving Single-Drug Immunosuppressive Therapy
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Healthy Volunteer Healthy volunteers without skin disease that received administration of Fluzone	Biological: Flu Vaccine; Administration of Fluzone (Influenza Vaccine)
Experimental: Azathioprine Patients with skin diseases taking azathioprine that received administration of Fluzone	Biological: Flu Vaccine; Administration of Fluzone (Influenza Vaccine)
Experimental: TNF alpha blocker Patients with skin diseases taking azathioprine that received administration of Fluzone	Biological: Flu Vaccine; Administration of Fluzone (Influenza Vaccine)

Outcome Measures

Primary Outcome Measures

1. Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination [28 days]

   Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.

2. Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination [28 days]

   Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 to 89 years of age

• Patient Taking azathioprine, Humira, Enbrel or Remicade

• Willing to participate in the healthy volunteer arm

Exclusion Criteria:

• Has received flu vaccine in past year

• Taking systemic corticosteroids or any other immunosuppressive drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University, Department of Dermatology	Atlanta	Georgia	United States	30322
2	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Robert Swerlick, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert A Swerlick MD, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01733056
• Other Study ID Numbers: IRB00044264; 5-31040
• First Posted: Nov 26, 2012
• Last Update Posted: Jul 21, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Robert A Swerlick MD, Professor, Emory University: Dermatology; Influenza Vaccine

Study Results

Participant Flow

Recruitment Details	43 subjects enrolled from Dept of dermatology, including 21 normal controls, 12 patients on TNF blockers for the treatment of skin diseases, and 10 patients treated with azathioprine for the treatment of skin diseases. Both serologic and cell based assays were completed before and after vaccination on all subjects.

Arm/Group Title	Healthy Volunteer	Azathioprine	TNF Alpha Blockers
Arm/Group Description
Period Title: Overall Study
STARTED	21	10	12
COMPLETED	21	10	12
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Healthy Volunteer	Azathioprine	TNF Alpha Blocker	Total
Arm/Group Description	Healthy volunteers without skin disease prior to influenza vaccination	Patients with skin diseases taking azathioprine	Patients with skin diseases taking TNF alpha blockers	Total of all reporting groups
Overall Participants	21	10	12	43
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	21 100%	9 90%	12 100%	42 97.7%
>=65 years	0 0%	1 10%	0 0%	1 2.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33 (9.5)	57 (7.3)	40 (11.6)	38.1 (15.1)
Sex: Female, Male (Count of Participants)
Female	13 61.9%	7 70%	3 25%	23 53.5%
Male	8 38.1%	3 30%	9 75%	20 46.5%
Region of Enrollment (participants) [Number]
United States	21 100%	10 100%	12 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination
Description	Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Volunteer	Azathioprine	TNF Alpha Blockers
Arm/Group Description	Healthy volunteers without skin disease prior to influenza vaccination	Patients with skin diseases taking azathioprine	Patients with skin diseases taking TNF alpha blockers
Measure Participants	21	10	12
Number [participants]	19 90.5%	5 50%	6 50%

2. Primary Outcome

Title	Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination
Description	Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Volunteer	Azathioprine	TNF Alpha Blockers
Arm/Group Description	Healthy volunteers without skin disease prior to influenza vaccination	Patients with skin diseases taking azathioprine	Patients with skin diseases taking TNF alpha blockers
Measure Participants	21	10	12
Number [participants]	15 71.4%	3 30%	6 50%

Adverse Events

Arm/Group Title	Healthy Volunteer Pre-vaccination		Healthy Volunteer Post-vaccination		Azathioprine Pre-vaccination		Azathioprine Post-vaccination		TNF Alpha Blocker Pre-vaccination		TNF Alpha Blocker Post-vaccination
Arm/Group Description	Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine		Healthy volunteers who had blood drawn after vaccination with influenza vaccine		Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine		Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine		Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine		Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine
All Cause Mortality
	Healthy Volunteer Pre-vaccination		Healthy Volunteer Post-vaccination		Azathioprine Pre-vaccination		Azathioprine Post-vaccination		TNF Alpha Blocker Pre-vaccination		TNF Alpha Blocker Post-vaccination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Healthy Volunteer Pre-vaccination		Healthy Volunteer Post-vaccination		Azathioprine Pre-vaccination		Azathioprine Post-vaccination		TNF Alpha Blocker Pre-vaccination		TNF Alpha Blocker Post-vaccination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)		0/10 (0%)		0/10 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Volunteer Pre-vaccination		Healthy Volunteer Post-vaccination		Azathioprine Pre-vaccination		Azathioprine Post-vaccination		TNF Alpha Blocker Pre-vaccination		TNF Alpha Blocker Post-vaccination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)		0/10 (0%)		0/10 (0%)		0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.