Trial Outcomes & Findings for Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL (NCT NCT00490529)

Last Updated: 2020-01-13

Results Overview

Molecular residual disease (MRD) is defined as detection in blood samples by the ClonoSEQ test of the (11;14) (q13;q32) gene translocation. It is considered positive if a tumor-specific VDJ sequence is detected in the peripheral blood cells by Ig-HTS at a frequency of greater or equal to 1 molecule per 10,000 input leukocyte equivalents of DNA within 1 year post-autologous stem cell transplant (ASCT). The outcome will be reported as number and percent of participants that maintain MRD-negative status (ie, 1-year freedom from MRD). This outcome is reported as a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

12 months

Results posted on

2020-01-13

Participant Flow

Some participants started study procedures, but did not receive the intended study treatment.

Participant milestones

Participant milestones
Measure	CpG-MCL Vaccine An autologous anti-tumor vaccine.
Completed Pre-CpG-MCL Vaccine Procedures STARTED	59
Completed Pre-CpG-MCL Vaccine Procedures COMPLETED	48
Completed Pre-CpG-MCL Vaccine Procedures NOT COMPLETED	11
Treatment With CpG-MCL Vaccine STARTED	48
Treatment With CpG-MCL Vaccine COMPLETED	47
Treatment With CpG-MCL Vaccine NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CpG-MCL Vaccine An autologous anti-tumor vaccine.
Completed Pre-CpG-MCL Vaccine Procedures Death	4
Completed Pre-CpG-MCL Vaccine Procedures Withdrawal by Subject	4
Completed Pre-CpG-MCL Vaccine Procedures Withdrawn, AHCT not suitable treatment	1
Completed Pre-CpG-MCL Vaccine Procedures Withdrawn, chemo not suitable treatment	1
Completed Pre-CpG-MCL Vaccine Procedures Withdrawal due to insurance refusal	1
Treatment With CpG-MCL Vaccine Received vaccine, did not receive AHCT	1

Baseline Characteristics

Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CpG-MCL Vaccine n=59 Participants An autologous anti-tumor vaccine.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Only participants for which molecular residual disease (MRD) disease status assessments were available are included.

Outcome measures

Outcome measures
Measure	CpG-MCL Vaccine n=45 Participants An autologous anti-tumor vaccine. CpG-MCL vaccine: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection. PF-3512676: PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. Vaccine-primed T-cells: Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells. Autologous hematopoietic stem cell transplant (HSCT): Regular medical procedure Rituximab: 375 mg/m² by infusion Standard induction chemotherapy: Patient-specific, regular medical care treatment as determined by treating oncologist Cyclophosphamide: Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT)	41 Participants

SECONDARY outcome

Timeframe: 7.7 years

Time-to-progression (TTP) is measured from the time of autologous stem cell transplantation (ASCT) until the cancer progresses or relapses. Progression is assessed based on CT imaging per the Cheson Criteria (2008). Progression per the Cheson Criteria is defined as having occurred when the sum of tumor lesion dimensions is ≥ 150% of the baseline value. The outcome is reported as the median with 95% confidence interval, as determined by Kaplan-Meier analysis and log-rank test.

Outcome measures

Outcome measures
Measure	CpG-MCL Vaccine n=47 Participants An autologous anti-tumor vaccine. CpG-MCL vaccine: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection. PF-3512676: PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. Vaccine-primed T-cells: Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells. Autologous hematopoietic stem cell transplant (HSCT): Regular medical procedure Rituximab: 375 mg/m² by infusion Standard induction chemotherapy: Patient-specific, regular medical care treatment as determined by treating oncologist Cyclophosphamide: Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Time-to-progression (TTP)	6.9 years Interval 5.92 to The upper end of the 95% confidence interval was not reached.

SECONDARY outcome

Timeframe: After 1, 2, 3, 4, and 5 years

Population: Only participants that received the CpG-MCL Vaccine are included.

Overall survival (OS) rate is reported as number and percentage of participants remaining alive the date of transplant through each year, up to 5 years (reported as a number without dispersion).

Outcome measures

Outcome measures
Measure	CpG-MCL Vaccine n=48 Participants An autologous anti-tumor vaccine. CpG-MCL vaccine: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection. PF-3512676: PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. Vaccine-primed T-cells: Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells. Autologous hematopoietic stem cell transplant (HSCT): Regular medical procedure Rituximab: 375 mg/m² by infusion Standard induction chemotherapy: Patient-specific, regular medical care treatment as determined by treating oncologist Cyclophosphamide: Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Overall Survival (OS) OS after 1 year	42 Participants
Overall Survival (OS) OS after 2 year	33 Participants
Overall Survival (OS) OS after 3 year	27 Participants
Overall Survival (OS) OS after 4 year	19 Participants
Overall Survival (OS) OS after 5 year	13 Participants

SECONDARY outcome

Timeframe: Baseline and after vaccination and transplant, approximately 5 years

Population: Only participants for which both baseline and post-transplant assessments were available are included.

Anti-tumor T-cell immune responses were evaluated by an in vitro evocative test on their peripheral blood mononuclear cell (PBMCs) before and after vaccination, as assessed by measurement of intracellular cytokines and/or intracellular perforin/granzyme in CD8+ T-cells, and/or CD137 induction on CD4+ T-cells. PBMCs were co-cultured with CpG-activated autologous MCL tumor cells and evaluated for tumor-specific immune responses as measured by CD137 expression on their T cells. The outcome is reported as the number of participants for whom tumor-specific memory CD8 cells were detected at baseline and after vaccination and transplant (numbers without dispersion).

Outcome measures

Outcome measures
Measure	CpG-MCL Vaccine n=35 Participants An autologous anti-tumor vaccine. CpG-MCL vaccine: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection. PF-3512676: PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. Vaccine-primed T-cells: Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells. Autologous hematopoietic stem cell transplant (HSCT): Regular medical procedure Rituximab: 375 mg/m² by infusion Standard induction chemotherapy: Patient-specific, regular medical care treatment as determined by treating oncologist Cyclophosphamide: Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination At Baseline	31 Participants
Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination After Transplant	14 Participants

SECONDARY outcome

Timeframe: Baseline and after vaccination and transplant, approximately 5 years

Population: Only participants for which both baseline and post-transplant assessments were available are included.

Anti-tumor T-cell immune responses were evaluated by an in vitro evocative test on their peripheral blood mononuclear cell (PBMCs) before and after vaccination, as assessed by measurement of intracellular cytokines and/or intracellular perforin/granzyme in CD8+ T-cells, and/or CD137 induction on CD4+ T-cells. PBMCs were co-cultured with CpG-activated autologous MCL tumor cells and evaluated for tumor-specific immune responses as measured by CD137 expression on their T cells. The outcome is reported as the number of participants for whom tumor-specific memory CD4 cells were detected at baseline and after transplant (numbers without dispersion).

Outcome measures

Outcome measures
Measure	CpG-MCL Vaccine n=35 Participants An autologous anti-tumor vaccine. CpG-MCL vaccine: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection. PF-3512676: PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. Vaccine-primed T-cells: Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells. Autologous hematopoietic stem cell transplant (HSCT): Regular medical procedure Rituximab: 375 mg/m² by infusion Standard induction chemotherapy: Patient-specific, regular medical care treatment as determined by treating oncologist Cyclophosphamide: Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination At Baseline	20 Participants
Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination After Transplant	14 Participants

Adverse Events

CpG-MCL Vaccine

Serious events: 31 serious events

Other events: 48 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	CpG-MCL Vaccine n=48 participants at risk An autologous anti-tumor vaccine.
Blood and lymphatic system disorders Febrile Neutropenia	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.3% 4/48 • Number of events 4 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Vascular disorders Supraventricular and nodal arrhythmia	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Death NOS	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	2.1% 1/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Nervous system disorders Hemorrhage, CNS, Intracranial hemorrhage	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Vascular disorders Thrombosis/embolism	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Graft failure	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Infections and infestations Infection, dental abscess	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Investigations Leukocytes (total WBC)	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Platelets	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Musculoskeletal and connective tissue disorders Myositis	2.1% 1/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death Disease progression	25.0% 12/48 • Number of events 12 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Burn	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).

Other adverse events

Other adverse events
Measure	CpG-MCL Vaccine n=48 participants at risk An autologous anti-tumor vaccine.
Musculoskeletal and connective tissue disorders Pain Joint (Arthalgia)	33.3% 16/48 • Number of events 35 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Psychiatric disorders Phantom sensations (sensitivity/crawly feeling on skin)	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Abdomen NOS	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Anorexia	8.3% 4/48 • Number of events 7 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Musculoskeletal and connective tissue disorders Hip pain	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Respiratory, thoracic and mediastinal disorders Cough	8.3% 4/48 • Number of events 4 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Diarrhea	8.3% 4/48 • Number of events 5 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Distension/bloating Abdominal (Gas/indigestion)	2.1% 1/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Nervous system disorders Dizziness	6.2% 3/48 • Number of events 3 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Fatigue	52.1% 25/48 • Number of events 53 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Fever	60.4% 29/48 • Number of events 63 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Febrile neutropenia	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Flu-like syndrome: General	8.3% 4/48 • Number of events 4 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Nervous system disorders Head/Headache	33.3% 16/48 • Number of events 26 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Heartburn/dyspepsia	10.4% 5/48 • Number of events 6 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Hyperpigmentation	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Nervous system disorders Imsomnia	4.2% 2/48 • Number of events 3 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Induration	29.2% 14/48 • Number of events 21 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Infections and infestations Metapneumovirus	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Injection site reaction/extravasation changes: Erythema	97.9% 47/48 • Number of events 123 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Injection site reaction/extravasation changes: Pain	39.6% 19/48 • Number of events 39 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Injection site reaction/extravasation changes: Swelling	50.0% 24/48 • Number of events 63 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Injection site reaction/extravasation changes: Warmth	35.4% 17/48 • Number of events 35 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Musculoskeletal and connective tissue disorders Joint Function	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Leukocytes count low	6.2% 3/48 • Number of events 3 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Lymphocytes count low	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Mucositis/Stomatitis	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Musculoskeletal and connective tissue disorders Myalgia	60.4% 29/48 • Number of events 62 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Respiratory, thoracic and mediastinal disorders nasal congestion	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Nausea	6.2% 3/48 • Number of events 4 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Investigations Neutrophils/granulocytes count low	8.3% 4/48 • Number of events 4 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Other: Granuloma	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Other: thinning/fragile skin	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Blood and lymphatic system disorders Platelets count low	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Pruritis/Itching	25.0% 12/48 • Number of events 15 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Skin and subcutaneous tissue disorders Rash/Desquamation	12.5% 6/48 • Number of events 6 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Rigors/Chills	45.8% 22/48 • Number of events 45 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Nervous system disorders Syncope	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Vascular disorders Thrombosis	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthia	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
Gastrointestinal disorders Vomiting	4.2% 2/48 • Number of events 2 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).
General disorders Weight Loss	2.1% 1/48 • Number of events 1 • 3 months The study has 2 stages, ie, procedures preceding vaccine administration + the vaccine treatment period. * All cause mortality includes the entire subject population (ie, both pre-vaccine period and actual treatment period). * Serious Adverse Events and Other (Not Including Serious) Adverse Events information includes only the participants that received the vaccine and transplant (actual study treatment period).

Additional Information

Ronald Levy

Stanford University

Phone: 650-725-6452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place