Trial Outcomes & Findings for ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM (NCT NCT05283109)
NCT ID: NCT05283109
Last Updated: 2026-04-30
Results Overview
A dose-limiting toxicity (DLT) is as an unacceptable toxicity, based on CTCAE v5.0, that occurs during the DLT observation period that extends between date of vaccine #1 (Day 1) and 30 days after vaccine #5 (Day 22). Any ≥ Grade 3 AEs were to be considered as unacceptable toxicities if they were possibly, probably, or definitely attributable to the protocol treatment regimen, and if they occurred within 30 days of vaccination. Specifically, any ≥ Grade 3 organ toxicity (cardiac, renal, hepatic), including CRS-related toxicities such as hypotension and tachycardia, of any duration was to be considered an unacceptable toxicity. A Grade 3 neurologic toxicity was only to be declared an unacceptable toxicity if not reversible within 48 hours. Grade 3 flu-like symptoms, fever, and chills/rigors were not considered unacceptable if the duration was less than 72 hours.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Approximately 2 months after initiation of P30-EPS study vaccine
Results posted on
2026-04-30
Participant Flow
3 enrollees decided not to participate in the study, 1 did not have Caris results in time to participate, and 2 were unable to participate due to no CMV negative slots being available at the time.
Participant milestones
| Measure |
Cohort 1: P30-EPS Vaccine; 300 µg/Peptide/Dose
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 300 µg/peptide/dose
|
Cohort 2: P30-EPS Vaccine; 400 µg/Peptide/Dose
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 400 µg/peptide/dose
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM
Baseline characteristics by cohort
| Measure |
Cohort 1: P30-EPS Vaccine; 300 µg/Peptide/Dose
n=6 Participants
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 300 µg/peptide/dose
|
Cohort 2: P30-EPS Vaccine; 400 µg/Peptide/Dose
n=12 Participants
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 400 µg/peptide/dose
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 17.1 • n=14 Participants
|
56.5 years
STANDARD_DEVIATION 20.6 • n=34 Participants
|
56.9 years
STANDARD_DEVIATION 19.0 • n=69 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=14 Participants
|
9 Participants
n=34 Participants
|
13 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=14 Participants
|
11 Participants
n=34 Participants
|
16 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=14 Participants
|
12 Participants
n=34 Participants
|
16 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=14 Participants
|
12 Participants
n=34 Participants
|
18 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 months after initiation of P30-EPS study vaccineA dose-limiting toxicity (DLT) is as an unacceptable toxicity, based on CTCAE v5.0, that occurs during the DLT observation period that extends between date of vaccine #1 (Day 1) and 30 days after vaccine #5 (Day 22). Any ≥ Grade 3 AEs were to be considered as unacceptable toxicities if they were possibly, probably, or definitely attributable to the protocol treatment regimen, and if they occurred within 30 days of vaccination. Specifically, any ≥ Grade 3 organ toxicity (cardiac, renal, hepatic), including CRS-related toxicities such as hypotension and tachycardia, of any duration was to be considered an unacceptable toxicity. A Grade 3 neurologic toxicity was only to be declared an unacceptable toxicity if not reversible within 48 hours. Grade 3 flu-like symptoms, fever, and chills/rigors were not considered unacceptable if the duration was less than 72 hours.
Outcome measures
| Measure |
Cohort 1: P30-EPS Vaccine; 300 µg/Peptide/Dose
n=6 Participants
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 300 µg/peptide/dose
|
Cohort 2: P30-EPS Vaccine; 400 µg/Peptide/Dose
n=12 Participants
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 400 µg/peptide/dose
|
|---|---|---|
|
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsStratified between CMV seropositive and seronegative patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 MonthsAmongst all patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 monthsStratified between CMV seropositive and seronegative patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 monthsAmongst all patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsAmongst all patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsAmongst all patients
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: P30-EPS Vaccine; 300 µg/Peptide/Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 5 deaths
Cohort 2: P30-EPS Vaccine; 400 µg/Peptide/Dose
Serious events: 1 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort 1: P30-EPS Vaccine; 300 µg/Peptide/Dose
n=6 participants at risk
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 300 µg/peptide/dose
|
Cohort 2: P30-EPS Vaccine; 400 µg/Peptide/Dose
n=12 participants at risk
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 400 µg/peptide/dose
|
|---|---|---|
|
Nervous system disorders
Dysphasia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
Other adverse events
| Measure |
Cohort 1: P30-EPS Vaccine; 300 µg/Peptide/Dose
n=6 participants at risk
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 300 µg/peptide/dose
|
Cohort 2: P30-EPS Vaccine; 400 µg/Peptide/Dose
n=12 participants at risk
The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. 400 µg/peptide/dose
|
|---|---|---|
|
General disorders
Pain
|
50.0%
3/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Injection Site Reaction
|
83.3%
5/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
75.0%
9/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Non-Cardiac Chest Pain
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Gait Disturbance
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
General Disorders And Administration Site Conditions - Other
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
50.0%
6/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Cardiac disorders
Sinus Tachycardia
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - Other
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Ear and labyrinth disorders
Ear Pain
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Eye disorders
Eye Disorders - Other
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Chills
|
50.0%
3/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
25.0%
3/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
41.7%
5/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Fever
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Flu Like Symptoms
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
50.0%
6/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Infections and infestations
Gum Infection
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Infections and infestations
Infections And Infestations - Other
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Infections and infestations
Upper Respiratory Infection
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - Other
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Creatinine Increased
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Lymphocyte Count Decreased
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Neutrophil Count Decreased
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
50.0%
6/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Platelet Count Decreased
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
41.7%
5/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
White Blood Cell Decreased
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
25.0%
3/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
50.0%
6/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
25.0%
3/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
25.0%
3/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Cognitive Disturbance
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Dysphasia
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
66.7%
8/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Memory Impairment
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Paresthesia
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
25.0%
3/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - Other
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Vascular disorders
Thromboembolic Event
|
16.7%
1/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
0.00%
0/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Eye disorders
Eye Pain
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Eye disorders
Periorbital Edema
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
General disorders
Edema Limbs
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Hemoglobin Increased
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Investigations
Inr Increased
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Nervous system disorders
Nervous System Disorders - Other
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
8.3%
1/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
16.7%
2/12 • Up to 6 months after initial study vaccine
From the time the participant receives vaccine 1 through the End of Study visit, all AEs must be recorded in the participant medical record and AEs case report form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place