Trial Outcomes & Findings for Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide (NCT NCT01282216)

Results Overview

Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

up to 6 months

Results posted on

2019-05-30

Participant Flow

8 recipients and 8 donors were screen failures prior to starting the study. 8 additional donors were vaccinated, but their intended recipients were never vaccinated and were replaced on study due to early relapse or graft failure. Data for the latter 8 donors has been lost and their arm assignment cannot be determined.

Participant milestones

Participant milestones
Measure	Donor PCV13 Donors receive PCV13 prior to bone marrow donation.	Donor Havrix Donors receive Havrix prior to bone marrow donation.	Recipient Vaccine Recipients receive Havrix and PCV13 post bone marrow transplant.	Donor - Assignment Unknown Donors in this group received either PCV13 or Havrix. Assignment cannot be determined due to missing study data.
Overall Study STARTED	18	26	52	8
Overall Study COMPLETED	18	26	19	0
Overall Study NOT COMPLETED	0	0	33	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Recipient Vaccine Recipients receive Havrix and PCV13 post bone marrow transplant.	Donor - Assignment Unknown Donors in this group received either PCV13 or Havrix. Assignment cannot be determined due to missing study data.
Overall Study Graft failure	3	2
Overall Study Physician Decision	11	0
Overall Study Relapse	17	6
Overall Study Death	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Donor Vaccine n=52 Participants Donors are randomized to receive either Havrix or PCV13 prior to bone marrow donation.	Recipient Vaccine n=52 Participants Recipients receive Havrix and PCV13 post bone marrow transplant.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=104 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=52 Participants	44 Participants n=52 Participants	94 Participants n=104 Participants
Age, Categorical >=65 years	2 Participants n=52 Participants	8 Participants n=52 Participants	10 Participants n=104 Participants
Age, Continuous	41.5 years n=52 Participants	54 years n=52 Participants	50 years n=104 Participants
Sex: Female, Male Female	21 Participants n=52 Participants	22 Participants n=52 Participants	43 Participants n=104 Participants
Sex: Female, Male Male	31 Participants n=52 Participants	30 Participants n=52 Participants	61 Participants n=104 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	52 Participants n=52 Participants	52 Participants n=52 Participants	104 Participants n=104 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure.

Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure.

Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, before receiving post-transplant vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure.

Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, and after receiving post-transplant vaccination.

Outcome measures

Outcome data not reported

Adverse Events

Donor Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Recipient Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rich Ambinder, MD

Johns Hopkins University

Phone: 4109558839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place