Trial Outcomes & Findings for Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (NCT NCT04015700)
NCT ID: NCT04015700
Last Updated: 2026-05-07
Results Overview
A DLT will be defined as any grade 3 toxicity or greater according to CTCAE v5 considered at least possibly related to study treatment. The DLT observation period begins with Cycle 1 Day 1 (date of first vaccine administration) and continues for 30 days
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Baseline characteristics by cohort
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
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|---|---|
|
Age, Continuous
|
62 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysA DLT will be defined as any grade 3 toxicity or greater according to CTCAE v5 considered at least possibly related to study treatment. The DLT observation period begins with Cycle 1 Day 1 (date of first vaccine administration) and continues for 30 days
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Safety and Tolerability of a Personalized Neoantigen DNA Vaccine as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-completion of radiotherapy (day 1 of cycle 1)The number of enrolled participants where at least one candidate tumor-specific neoantigen was identified for vaccine inclusion. Candidate neoantigen identification was done through tumor sequencing and in silico prediction algorithms prioritizing expressed (inferred by RNAseq) and presented (patient specific HLA class 1 molecule-restricted) peptides.
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Feasibility of Generating a Personalized Neoantigen DNA Vaccine for Patients With Newly Diagnosed, Unmethylated GBM as Measured by the Number of Participants Who Had Candidate Tumor-specific Neoantigens Identified
|
9 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-completion of radiotherapy (day 1 of cycle 1)The number of enrolled participants with identifiable candidate tumor-specific neoantigen(s) who had a personalized DNA vaccine successfully manufactured.
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Feasibility of Generating a Personalized Neoantigen DNA Vaccine for Patients With Newly Diagnosed, Unmethylated GBM as Measured by the Number of Participants With a Manufactured Neoantigen-based DNA Vaccine
|
9 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-completion of radiotherapy (estimated to be day 1 of cycle 1)The number of enrolled participants with identifiable candidate tumor-specific neoantigen(s) who had a personalized DNA vaccine successfully manufactured and administered by 4 weeks post-completion of radiation therapy.
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Feasibility of Generating a Personalized Neoantigen DNA Vaccine for Patients With Newly Diagnosed, Unmethylated GBM as Measured by the Number of Participants Who Had the First Vaccine Administered at 4 Weeks Post-completion of Radiotherapy
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10 following vaccination on day 1 of cycle 1Population: The ELISPOT assay analysis could not be completed because there was not enough peripheral blood collected from the participant to isolate sufficient CD8 T cells to assess response to all individual neoantigens. In order to collect the amount of blood needed, the participant would have been required to undergo leukapheresis and the participants either declined or a central line was not able to be placed. Peripheral blood will not be collected in the future for analysis as all but 1 is deceased.
CD8 T cells will be isolated from peripheral blood samples and will be stimulated with pooled peptides corresponding to the patient-specific neoantigen candidates included in the respective DNA vaccine. Response will be measured by IFN gamma production via ELISPOT assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 10 following vaccination on day 1 of cycle 1Population: The ELISPOT assay analysis could not be completed because there was not enough peripheral blood collected from the participants to isolate sufficient CD8 T cells to assess response to all individual neoantigens. In order to collect the amount of blood needed, the participant would have been required to undergo leukapheresis \& the participants either declined or a central line was not able to be placed. Peripheral blood will not be collected in the future for analysis as all but 1 is deceased.
CD8 T cells will be isolated from peripheral blood samples and will be stimulated with individual peptides corresponding to the patient-specific neoantigen candidates included in the respective DNA vaccine. Response will be measured by IFN gamma production via ELISPOT assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks post-completion of radiotherapy (day 1 of cycle 1)-High quality neoantigens will be defined as those that meet criteria for inclusion in a vaccine
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
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|---|---|
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Number of High Quality Candidates Neoantigens Present in Participants With Newly Diagnosed GBM
|
36 neoantigens per patient
Interval 17.0 to 40.0
|
SECONDARY outcome
Timeframe: 6 months-Progression is defined as any of the following * ≥ 25% increase in sum products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids\*. The absolute increase in any dimension must be at least 5mm when calculating the products. * Significant increase in T2/FLAIR nonenhancing lesion on stable/increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy\* not caused by comorbid events * New measurable lesion. * Clear clinical deterioration not attributable to other causes apart from the tumor (e.g. seizures, medication adverse effects, complications of therapy, cerebrovascular events, infection, and so on) or changes in corticosteroid dose.
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
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|---|---|
|
The Percentage of Participants Who Did Not Progress or Expire by 6 Months From Time of Diagnosis
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
The Percentage of Participants Who Did Not Expire by 12 Months From Time of Diagnosis
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to week 24 post-vaccination (day 1 of cycle 1)Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Immunogenicity of a Personalized Neoantigen DNA Vaccine as Measured by the Number of Participants That Had the T-cell Phenotype, Myeloid Derived Suppressor Cell Frequency by Flow Cytometry Analysis Performed
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to week 24 post-vaccination (day 1 of cycle 1)Measured by the number of patients that the analysis was able to be performed.
Outcome measures
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 Participants
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Immunogenicity of a Personalized Neoantigen DNA Vaccine as Measured by the Number of Participants That Had the Diversity of Clonality From T Cell Receptor Sequencing Analysis Performed
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to week 24 post-vaccination (day 1 of cycle 1)Population: The T cell sequencing analysis could not be completed because there was not enough peripheral blood collected from the participants. In order to collect the amount of blood needed, the participant would have been required to undergo leukapheresis and the participants either declined or a central line was not able to be placed. Peripheral blood will not be collected in the future for analysis as all but 1 is deceased.
Outcome measures
Outcome data not reported
Adverse Events
Vaccine (GNOS-PV01 + INO-9012)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 participants at risk
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Disease progression
|
33.3%
3/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Fever
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Shunt malfunction
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Infections and infestations
Appendicitis
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Infections and infestations
Meningitis
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Infections and infestations
Rhinovirus
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Infections and infestations
Wound infection
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Injury, poisoning and procedural complications
Fracture
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
CSF leak
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Facial muscle weakness
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Seizure
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Psychiatric disorders
Disoriented
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
Other adverse events
| Measure |
Vaccine (GNOS-PV01 + INO-9012)
n=9 participants at risk
* Standard radiation therapy will be administered per standard of care and is outside the scope of this study.
* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Eye disorders
Double vision
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Eye disorders
Vision decreased
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Chills
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Fatigue
|
33.3%
3/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Fever
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Generalized edema
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Injection site reaction
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Irritation around incision
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Pain
|
33.3%
3/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
General disorders
Pain with vaccination
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Infections and infestations
Shingles
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Injury, poisoning and procedural complications
Bruising
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
3/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness after vaccine
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
3/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Aphasia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Dizziness
|
77.8%
7/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Dysarthria
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Dysphasia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Edema cerebral
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Facial paralysis
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Imbalance
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Psychiatric disorders
Depression
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Psychiatric disorders
Mental status change
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Renal and urinary disorders
Urinary urgency
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Rosacea face
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Surgical and medical procedures
Opening of surgical site and darkness around suture line
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Adverse events were collected from start of treatment through 100 days following the last day of treatment (median length of follow-up 166 days, full range 101-1297 days). All-cause mortality was collected from start of treatment up to 24 months after their last dose of vaccine or until death (median length of follow-up 318 days, full range 101-1535 days).
|
Additional Information
Tanner M. Johanns, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-273-2723
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place