Trial Outcomes & Findings for Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly (NCT NCT01232868)

Last Updated: 2015-11-30

Results Overview

The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)

Results posted on

2015-11-30

Participant Flow

Atlanta Metropolitan Area 2010-2011

There were 4 screen failures : * one unable to obtain blood pre-vaccination * two with elevated blood pressure readings * one with progressive medical illness

Participant milestones

Participant milestones
Measure	Age 25-40 Years Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
Overall Study STARTED	22	44
Overall Study COMPLETED	20	40
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Age 25-40 Years Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age 25-40 Years n=22 Participants Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years n=44 Participants Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Total n=66 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
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	41 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	40 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	44 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)

Outcome measures

Outcome measures
Measure	Age 25-40 Years n=22 Participants Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years n=44 Participants Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures	22 participants	44 participants

SECONDARY outcome

Timeframe: 2 years

The secondary outcomes will identify the number of participants with a positive B cell response to the flu shot particulary looking for antibody responses, presence of plasmablasts, antibody repertoire.

Outcome measures

Outcome measures
Measure	Age 25-40 Years n=22 Participants Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years n=44 Participants Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures	21 participants	40 participants

Adverse Events

Age 25-40 Years

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Age ≥65 Years

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Age 25-40 Years n=22 participants at risk Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years n=44 participants at risk Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
Hepatobiliary disorders Cholangiocarcinoma	0.00% 0/22 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	2.3% 1/44 • Number of events 1 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Endocrine disorders Multiorgan Failure	0.00% 0/22 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	2.3% 1/44 • Number of events 1 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Gastrointestinal disorders Ileus	0.00% 0/22 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	2.3% 1/44 • Number of events 1 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Infections and infestations Death	0.00% 0/22 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	2.3% 1/44 • Number of events 1 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)

Other adverse events

Other adverse events
Measure	Age 25-40 Years n=22 participants at risk Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.	Age ≥65 Years n=44 participants at risk Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
Blood and lymphatic system disorders Bruise	9.1% 2/22 • Number of events 2 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	20.5% 9/44 • Number of events 9 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Skin and subcutaneous tissue disorders Induration/Swelling	9.1% 2/22 • Number of events 2 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	6.8% 3/44 • Number of events 3 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Skin and subcutaneous tissue disorders Tenderness	45.5% 10/22 • Number of events 10 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	47.7% 21/44 • Number of events 21 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Nervous system disorders Headache	13.6% 3/22 • Number of events 3 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	15.9% 7/44 • Number of events 7 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)
Gastrointestinal disorders Nausea	9.1% 2/22 • Number of events 2 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)	13.6% 6/44 • Number of events 6 • 6 months Reactogenecity for 7 days post vaccination AE for 30 days SAE for 180 days (None of the SAE were related to the vaccine-One participant had choliangiocarcinoma and bacteremia and multiorgan failure and died 6 months after receiving TIV- another SAE was in a participant with hospitalization for small bowel obstruction with complete recovery)

Additional Information

Nadine Rouphael, MD

Emory University

Phone: 404-712-1435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place