Trial Outcomes & Findings for Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression (NCT NCT01733056)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

28 days

Results posted on

2014-07-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Healthy Volunteer	Azathioprine	TNF Alpha Blockers
Overall Study STARTED	21	10	12
Overall Study COMPLETED	21	10	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteer n=21 Participants Healthy volunteers without skin disease prior to influenza vaccination	Azathioprine n=10 Participants Patients with skin diseases taking azathioprine	TNF Alpha Blocker n=12 Participants Patients with skin diseases taking TNF alpha blockers	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	42 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	33 years STANDARD_DEVIATION 9.5 • n=5 Participants	57 years STANDARD_DEVIATION 7.3 • n=7 Participants	40 years STANDARD_DEVIATION 11.6 • n=5 Participants	38.1 years STANDARD_DEVIATION 15.1 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	10 participants n=7 Participants	12 participants n=5 Participants	43 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Volunteer n=21 Participants Healthy volunteers without skin disease prior to influenza vaccination	Azathioprine n=10 Participants Patients with skin diseases taking azathioprine	TNF Alpha Blockers n=12 Participants Patients with skin diseases taking TNF alpha blockers
Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination	19 participants	5 participants	6 participants

PRIMARY outcome

Timeframe: 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.