Trial Outcomes & Findings for Influenza Vaccine Post Allogeneic Transplant (NCT NCT01215981)

NCT ID: NCT01215981

Last Updated: 2017-12-28

Results Overview

The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 8 Weeks After Vaccination
• Results posted on: 2017-12-28

Participant Flow

The original study design included healthy adult volunteers in addition to the HSCT recipients; however, the protocol was modified to exclude the healthy volunteers.

Participant milestones

Measure	HSCT Recipients Who Were Randomized to 1 Vaccine Dose	HSCT Recipients Who Were Randomized to 2 Vaccine Doses
Overall Study STARTED	35	33
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	HSCT Recipients Who Were Randomized to 1 Vaccine Dose	HSCT Recipients Who Were Randomized to 2 Vaccine Doses
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Influenza Vaccine Post Allogeneic Transplant

Baseline characteristics by cohort

Measure	HSCT Recipients Who Were Randomized to 1 Vaccine Dose n=33 Participants	HSCT Recipients Who Were Randomized to 2 Vaccine Doses n=32 Participants	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 Weeks After Vaccination

Population: One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.

The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.

Outcome measures

Measure	HSCT Recipients Who Were Randomized to 1 Vaccine Dose n=32 Participants Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.	HSCT Recipients Who Were Randomized to 2 Vaccine Doses n=32 Participants Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
Number of Subjects With T-Cell Based Immune Response to Vaccine	14 Patients	15 Patients

SECONDARY outcome

Timeframe: 8 Weeks After Vaccination

Population: One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.

The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.

Outcome measures

Measure	HSCT Recipients Who Were Randomized to 1 Vaccine Dose n=32 Participants Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.	HSCT Recipients Who Were Randomized to 2 Vaccine Doses n=32 Participants Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
Number of Subjects With H3 Based Immune Response to Vaccine	4 Patients	7 Patients

Adverse Events

HSCT Recipients Who Were Randomized to 1 Vaccine Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HSCT Recipients Who Were Randomized to 2 Vaccine Doses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Verneris, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-626-2961

Email: verneris@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place