Trial Outcomes & Findings for IDH1 Peptide Vaccine for Recurrent Grade II Glioma (NCT NCT02193347)
NCT ID: NCT02193347
Last Updated: 2023-12-01
Results Overview
The percentage of patients who experience an unacceptable toxicity defined as any Grade 3 toxicity at least possibly attributed to the vaccine (or vaccine + TMZ and/or RT) that does not resolve to baseline within 3 weeks, any Grade 3 hypersensitivity reactions requiring steroids, any Grade 4 toxicity, including neurologic events not due to progressive disease, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Date of consent through 2 months after the last vaccination
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
PEPIDH1M Vaccine
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
Baseline characteristics by cohort
| Measure |
PEPIDH1M Vaccine
n=24 Participants
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
|
|---|---|
|
Age, Continuous
|
43.83 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of consent through 2 months after the last vaccinationThe percentage of patients who experience an unacceptable toxicity defined as any Grade 3 toxicity at least possibly attributed to the vaccine (or vaccine + TMZ and/or RT) that does not resolve to baseline within 3 weeks, any Grade 3 hypersensitivity reactions requiring steroids, any Grade 4 toxicity, including neurologic events not due to progressive disease, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression.
Outcome measures
| Measure |
PEPIDH1M Vaccine
n=24 Participants
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
|
|---|---|
|
Percentage of Participants With an Unacceptable Toxicity
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From time of pheresis #1, one day prior to first pre-surgery vaccine dose, until the time of the third post-surgery vaccination, an expected average of 24 weeks after study initiationPopulation: Only 21 of the 24 overall study patients made it far enough on the study to receive 3 post-surgery vaccines and become evaluable for this outcome.
Assess the immunogenicity of the PEPIDH1M vaccine with adjuvant TMZ using ELISpot. This will be done by finding the difference between the number of SFC after 3 post-surgery vaccines and the number of SFC at baseline for each evaluable subject. Immunogenicity will then be summarized by the percentage of evaluable subjects who have a positive vaccine response after 3 post-surgery vaccines. A response will be considered positive if the difference in SFC measurement is greater than 20 SFC per 10\^6 lymphocytes after determining the level of detection in the IDH ELISpot.
Outcome measures
| Measure |
PEPIDH1M Vaccine
n=21 Participants
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
|
|---|---|
|
Percentage of Patients With a Positive Vaccine Response After 3 Post-Surgery Vaccines as Measured by IFNγ ELIspot
|
42.86 Percentage of evaluable participants
|
Adverse Events
PEPIDH1M Vaccine
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEPIDH1M Vaccine
n=24 participants at risk
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Cardiac disorders
Ventricular arrhythmia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: CELLULITIS
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Platelet count decreased
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
White blood cell decreased
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
Other adverse events
| Measure |
PEPIDH1M Vaccine
n=24 participants at risk
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
PEPIDH1M vaccine: PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Tetanus-Diphtheria Toxoid (Td): After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Temozolomide: Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
|
|---|---|
|
Nervous system disorders
Other, Specify: AURA
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: DECREASED CIRCULATION IN FEET; BILATERAL
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: FOREHEAD NUMBNESS. POST INJECTION #1.
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: INTRACRANIAL ANEURYSM, NONRUPTURED
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: L HEMIPARESIS
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
20/24 • Date of consent through 2 months after the last vaccination
|
|
Cardiac disorders
Sinus tachycardia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Ear and labyrinth disorders
Other, Specify: "INNER EAR PRESSURE"
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Ear and labyrinth disorders
Other, Specify: BLOOD TINGED DRAINAGE
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Ear and labyrinth disorders
Other, Specify: CLICKING SOUND IN LEFT EAR
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Ear and labyrinth disorders
Other, Specify: HEARS CLINKING SOUND IN HEAD INTERMITTENTLY
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Blurred vision
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Dry eye
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Other, Specify: INTERMITTENT PAIN, TWITCHING, AND/OR NUMBNESS UNDER RIGHT EYE
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Other, Specify: INTERMITTENT; OBJECTS APPEAR TO MOVE OR SHAKE WHEN HOLDING
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Other, Specify: L EYELID EDEMA
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Other, Specify: SEEING A "BROWNISH TINTED VERTICAL STRIPE" FROM RIGHT EYE
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Other, Specify: TUNNEL VISION
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Eye pain
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Eye disorders
Floaters
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Constipation
|
45.8%
11/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Nausea
|
41.7%
10/24 • Date of consent through 2 months after the last vaccination
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Chills
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Edema face
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Fatigue
|
54.2%
13/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Fever
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Flu like symptoms
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Gait disturbance
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Infusion related reaction
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Injection site reaction
|
100.0%
24/24 • Date of consent through 2 months after the last vaccination
|
|
General disorders
Pain
|
20.8%
5/24 • Date of consent through 2 months after the last vaccination
|
|
Immune system disorders
Allergic reaction
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Bronchial infection
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: CELLULITIS
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: COLD SORES
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: HEAD INCISION WITH DRAINAGE AND TENDERNESS; 2+ SERRATIA MARCESCENS
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: INCISION, ABNORMAL TISSUE CULTURE
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: SHINGLES
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Other, Specify: WOUND INFECTION
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Mucosal infection
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Papulopustular rash
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Sinusitis
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
6/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Infections and infestations
Wound infection
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Injury, poisoning and procedural complications
Bruising
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Injury, poisoning and procedural complications
Other, Specify: LEFT WRIST WOUND
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Injury, poisoning and procedural complications
Other, Specify: LOWER BACK INJURY
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Injury, poisoning and procedural complications
Other, Specify: MVA
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
9/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
9/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Blood bilirubin increased
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Creatinine increased
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Lymphocyte count decreased
|
20.8%
5/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Neutrophil count decreased
|
20.8%
5/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
Platelet count decreased
|
25.0%
6/24 • Date of consent through 2 months after the last vaccination
|
|
Investigations
White blood cell decreased
|
29.2%
7/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
79.2%
19/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
6/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
12/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
6/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hyponatremia
|
29.2%
7/24 • Date of consent through 2 months after the last vaccination
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, Specify: BUMPS ON R FOREARM
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, Specify: L WRIST BUMP/NODULE
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Concentration impairment
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Dizziness
|
29.2%
7/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Dysphasia
|
33.3%
8/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Facial nerve disorder
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Headache
|
41.7%
10/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Memory impairment
|
20.8%
5/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Movements involuntary
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: L SIDED NEGLECT
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: NIGHTMARES
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Other, Specify: PSEUDOMENINGOCELE
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Paresthesia
|
29.2%
7/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Pyramidal tract syndrome
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Seizure
|
33.3%
8/24 • Date of consent through 2 months after the last vaccination
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Psychiatric disorders
Anxiety
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Psychiatric disorders
Depression
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
Psychiatric disorders
Hallucinations
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Psychiatric disorders
Insomnia
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
Psychiatric disorders
Restlessness
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Renal and urinary disorders
Hematuria
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Renal and urinary disorders
Other, Specify: "PASSING AIR WHEN URINATING"
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Renal and urinary disorders
Urinary retention
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Renal and urinary disorders
Urinary urgency
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Reproductive system and breast disorders
Other, Specify: LUMP IN LEFT BREAST
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Reproductive system and breast disorders
Testicular pain
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
3/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Other, Specify: CONGESTION
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.8%
5/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
4/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Other, Specify: FLUID FILLED POCKET ON R FOREHEAD FROM SURGERY
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Other, Specify: FLUID POCKET
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Other, Specify: RASH
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Other, Specify: RIGHT LOWER EXTREMITY. SKIN DISCOLORATION.
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Other, Specify: SKIN BUMP
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Other, Specify: SKIN SLOUGHING
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
70.8%
17/24 • Date of consent through 2 months after the last vaccination
|
|
Vascular disorders
Hypertension
|
100.0%
24/24 • Date of consent through 2 months after the last vaccination
|
|
Vascular disorders
Thromboembolic event
|
4.2%
1/24 • Date of consent through 2 months after the last vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place