Trial Outcomes & Findings for Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD (NCT NCT00278200)
NCT ID: NCT00278200
Last Updated: 2023-04-25
Results Overview
Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection.
TERMINATED
PHASE1
23 participants
Up to 67 days
2023-04-25
Participant Flow
One subject on the EBV seronegative arm was a screen failure. One EBV seronegative subject was not assigned to intervention arm due to physician decision. Seven EBV seropositive subjects were not assigned to intervention arm: three due to physician decision; one due to loss of follow-up; one due to death; and two due to subject withdrawal.
Participant milestones
| Measure |
EBV Seronegative
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
|
EBV Seropositive
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
12
|
|
Overall Study
COMPLETED
|
1
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
EBV Seronegative
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
|
EBV Seropositive
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EBV Seronegative
n=2 Participants
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
Inactivated EBV-infected vaccine
|
EBV Seropositive
n=12 Participants
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
Inactivated EBV-infected vaccine
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
10 Participants
n=12 Participants
|
12 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
|
Age, Continuous
|
38 years
n=2 Participants
|
54 years
n=12 Participants
|
54 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
4 Participants
n=12 Participants
|
6 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 Participants
n=2 Participants
|
12 Participants
n=12 Participants
|
14 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Up to 67 daysPopulation: T-cell responses were uninterpretable on lab analysis; therefore, data was not collected to assess this outcome measure.
Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of participants who received at least one vaccination and experienced at least one grade 3-4 adverse event by CTCAE 2.0 that was attributed to protocol therapy.
Outcome measures
| Measure |
EBV Seronegative
n=2 Participants
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
Inactivated EBV-infected vaccine
|
EBV Seropositive
n=12 Participants
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
Inactivated EBV-infected vaccine
|
|---|---|---|
|
Adverse Events Associated With the Vaccine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Only one participant met the criteria described in the outcome description. This participant was never tested post-transplant for EBV, so no data was collected for this outcome measure.
Number of participants who were EBV-seronegative at baseline, received at least one vaccination, subsequently received a solid organ transplant (not part of this protocol), and did not develop a primary EBV infection.
Outcome measures
Outcome data not reported
Adverse Events
EBV Seronegative
EBV Seropositive
Serious adverse events
| Measure |
EBV Seronegative
n=2 participants at risk
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
|
EBV Seropositive
n=12 participants at risk
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
|
|---|---|---|
|
Infections and infestations
Bacteremia
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
50.0%
1/2 • Number of events 1 • Up to 5 years
|
0.00%
0/12 • Up to 5 years
|
Other adverse events
| Measure |
EBV Seronegative
n=2 participants at risk
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline.
|
EBV Seropositive
n=12 participants at risk
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
|
|---|---|---|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/2 • Up to 5 years
|
16.7%
2/12 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 2 • Up to 5 years
|
|
General disorders
Cough
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Diplopia
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
General disorders
Headache
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 2 • Up to 5 years
|
|
General disorders
Hypertension
|
0.00%
0/2 • Up to 5 years
|
16.7%
2/12 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
50.0%
1/2 • Number of events 4 • Up to 5 years
|
41.7%
5/12 • Number of events 15 • Up to 5 years
|
|
Investigations
Leukopenia
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
General disorders
Pain - unspecified
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Pain - abdomen
|
50.0%
1/2 • Number of events 1 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain - axilla
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Sore throat
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Streptococcal pharyngitis
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Investigations
Thrombocytopenia
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/2 • Up to 5 years
|
16.7%
2/12 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Up to 5 years
|
8.3%
1/12 • Number of events 1 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place