Trial Outcomes & Findings for Dose Escalating Study of Intramuscular Invaplex[AR-DETOX] (NCT NCT03869333)
NCT ID: NCT03869333
Last Updated: 2021-07-29
Results Overview
All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered "serious" if it resulted in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly/birth defect. The Investigator assessed the relationship of each adverse event to study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
From first dose up to 28 days following the third immunization (71 days)
Results posted on
2021-07-29
Participant Flow
This study was conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, MD, USA. Healthy adults were recruited from the Baltimore/Washington, DC area.
In this dose-escalation study participants were assigned to receive 3 vaccinations of 1 of 3 doses of detoxified Shigella flexneri 2a artificial invasin complex (Invaplex\[AR-Detox\]) or placebo. The study was initiated with the lowest dose level (2.5 μg) and proceeded to the next highest dose in an escalating fashion after review of safety data by the Protocol Safety Review Team. Within each dose cohort participants were randomly assigned to receive Invaplex\[AR-Detox\] or placebo in a 4: 1 ratio.
Participant milestones
| Measure |
Invaplex[AR-Detox] 2.5 μg
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
16
|
12
|
|
Overall Study
Received First Dose
|
14
|
16
|
16
|
12
|
|
Overall Study
Received Second Dose
|
13
|
15
|
16
|
12
|
|
Overall Study
Received Third Dose
|
13
|
15
|
16
|
11
|
|
Overall Study
COMPLETED
|
12
|
15
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Invaplex[AR-Detox] 2.5 μg
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
Baseline characteristics by cohort
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=14 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=16 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
33.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
28.9 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
32.5 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 28 days following the third immunization (71 days)Population: The safety population included all participants who received at least one immunization (Invaplex\[AR-Detox\] or placebo).
All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered "serious" if it resulted in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly/birth defect. The Investigator assessed the relationship of each adverse event to study drug.
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=14 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=16 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
Any adverse event (AE)
|
100 percentage of participants
Interval 76.84 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
91.7 percentage of participants
Interval 61.52 to 99.79
|
|
Percentage of Participants With Adverse Events
Any Grade 2 or greater AE
|
50.0 percentage of participants
Interval 23.04 to 76.96
|
56.3 percentage of participants
Interval 29.88 to 80.25
|
43.8 percentage of participants
Interval 19.75 to 70.12
|
25.0 percentage of participants
Interval 5.49 to 57.19
|
|
Percentage of Participants With Adverse Events
Any AE related to study drug
|
100.0 percentage of participants
Interval 76.84 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
58.3 percentage of participants
Interval 27.67 to 84.83
|
|
Percentage of Participants With Adverse Events
Any Grade 2 or greater AE related to study drug
|
14.3 percentage of participants
Interval 1.78 to 42.81
|
43.8 percentage of participants
Interval 19.75 to 70.12
|
31.3 percentage of participants
Interval 11.02 to 58.66
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
|
Percentage of Participants With Adverse Events
Any serious adverse event (SAE)
|
0.0 percentage of participants
Interval 0.0 to 23.16
|
0.0 percentage of participants
Interval 0.0 to 20.59
|
0.0 percentage of participants
Interval 0.0 to 20.59
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With Adverse Events
Any SAE related to study drug
|
0.0 percentage of participants
Interval 0.0 to 23.16
|
0.0 percentage of participants
Interval 0.0 to 20.59
|
0.0 percentage of participants
Interval 0.0 to 20.59
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
PRIMARY outcome
Timeframe: 7 days after the first immunization (Days 1 to 7)Population: All participants who received the first dose (Invaplex\[AR-Detox\] or placebo).
The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=14 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=16 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Any Solicited AE
|
13 Participants
|
16 Participants
|
16 Participants
|
6 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Abdominal pain
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Appetite disorder
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Arthralgia
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Diarrhoea
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Fatigue
|
1 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Headache
|
3 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Malaise
|
2 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Myalgia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Nausea
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Pyrexia
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Vaccination site erythema
|
8 Participants
|
9 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Vaccination site induration
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Vaccination site pain
|
12 Participants
|
16 Participants
|
16 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Vaccination site pruritus
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1
Vaccination site swelling
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 7 days after the second immunization (Days 22 to 28)Population: All participants who received the second dose (Invaplex\[AR-Detox\] or placebo).
The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Any Solicited AE
|
12 Participants
|
15 Participants
|
15 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Abdominal pain
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Appetite disorder
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Arthralgia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Diarrhoea
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Fatigue
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Headache
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Malaise
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Myalgia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Nausea
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Vaccination site erythema
|
9 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Vaccination site induration
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Vaccination site pain
|
7 Participants
|
15 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Vaccination site pruritus
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2
Vaccination site swelling
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days after the third immunization (Days 43 to 49)Population: All participants who received the third dose (Invaplex\[AR-Detox\] or placebo).
The solicited AEs for this study included: * Site pain * Site tenderness * Swelling * Induration (determined by investigator exam) * Site redness * Pruritus * Fever * Nausea * Vomiting * Abdominal pain * Diarrhea (loose stools) * Appetite change * Fatigue * Headache * Myalgias (general pain or soreness in muscles) * Arthralgias (general pain in joints) * Malaise
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=11 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events After Dose 3
Any Solicited AE
|
11 Participants
|
15 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Abdominal pain
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Appetite disorder
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Arthralgia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Fatigue
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Headache
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Malaise
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Myalgia
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Vaccination site erythema
|
10 Participants
|
9 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Vaccination site induration
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Vaccination site pain
|
7 Participants
|
11 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Vaccination site pruritus
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events After Dose 3
Vaccination site swelling
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71Population: Participants who received each dose (Invaplex\[AR-Detox\] or placebo).
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=14 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=16 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events After Each Dose
Unsolicited adverse events after first dose
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Each Dose
Unsolicited adverse events after second dose
|
7 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Each Dose
Unsolicited adverse events after third dose
|
4 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 22, 43, 50, 57 and 71.Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Baseline
|
189.6 titer
Interval 101.3 to 355.1
|
126.0 titer
Interval to 206.8
Less than the lower limit of quantitation
|
141.4 titer
Interval to 246.6
Less than the lower limit of quantitation
|
200.0 titer
Interval 117.6 to 340.2
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Day 22 (pre-dose 2)
|
3560.1 titer
Interval 1077.5 to 11762.5
|
2917.5 titer
Interval 1607.8 to 5294.0
|
14576.5 titer
Interval 7212.2 to 29460.2
|
188.8 titer
Interval 127.0 to 280.6
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Day 43 (pre-dose 3)
|
3375.3 titer
Interval 955.5 to 11922.4
|
2425.1 titer
Interval 1443.2 to 4075.3
|
9451.7 titer
Interval 4631.8 to 19287.4
|
165.6 titer
Interval to 276.8
Less than the lower limit of quantitation
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Day 50 (7 days after dose 3)
|
3200.0 titer
Interval 975.8 to 10494.3
|
2785.8 titer
Interval 1612.5 to 4812.6
|
11033.3 titer
Interval 5649.8 to 21546.2
|
149.8 titer
Interval to 241.5
Less than the lower limit of quantitation
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Day 57 (14 days after dose 3)
|
4271.5 titer
Interval 1293.7 to 14103.6
|
3200.0 titer
Interval 1729.1 to 5922.1
|
10307.1 titer
Interval 5419.5 to 19602.9
|
178.2 titer
Interval 109.1 to 291.1
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex
Day 71 (28 days after dose 3)
|
4031.7 titer
Interval 1063.9 to 15279.1
|
2211.1 titer
Interval 1158.1 to 4221.3
|
9451.7 titer
Interval 4883.7 to 18292.3
|
211.9 titer
Interval 126.9 to 353.9
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 22, 43, 50, 57 and 71.Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Baseline
|
1516.9 titer
Interval 850.2 to 2706.4
|
1269.9 titer
Interval 592.0 to 2723.9
|
2166.8 titer
Interval 1308.9 to 3587.0
|
1695.1 titer
Interval 830.0 to 3461.9
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Day 22 (pre-dose 2)
|
15020.3 titer
Interval 4474.5 to 50421.6
|
22286.1 titer
Interval 11426.7 to 43465.7
|
75613.5 titer
Interval 41386.6 to 138146.2
|
1795.9 titer
Interval 916.5 to 3519.3
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Day 43 (pre-dose 3)
|
25600.0 titer
Interval 8027.0 to 81644.6
|
29406.7 titer
Interval 15572.4 to 55531.0
|
106933.6 titer
Interval 65186.0 to 175418.1
|
1704.1 titer
Interval 696.6 to 4168.8
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Day 50 (7 days after dose 3)
|
27122.3 titer
Interval 8727.4 to 84288.0
|
37050.1 titer
Interval 20418.3 to 67229.4
|
113058.8 titer
Interval 70861.9 to 180383.0
|
1795.9 titer
Interval 996.7 to 3236.2
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Day 57 (14 days after dose 3)
|
34171.9 titer
Interval 11722.7 to 99611.8
|
44572.2 titer
Interval 22853.4 to 86931.5
|
116612.0 titer
Interval 79218.2 to 171656.8
|
2015.9 titer
Interval 1135.8 to 3577.8
|
|
Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex
Day 71 (28 days after dose 3)
|
36203.9 titer
Interval 13769.6 to 95189.5
|
42559.4 titer
Interval 23621.8 to 76679.4
|
106933.6 titer
Interval 65186.0 to 175418.1
|
1425.4 titer
Interval 747.1 to 2719.6
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, and 50Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)
Baseline
|
1.1 titer
Interval 0.9 to 1.2
|
1.3 titer
Interval 1.0 to 1.7
|
1.1 titer
Interval 1.0 to 1.3
|
1.0 titer
Confidence interval could not be calculated as there was no variation among participants in this arm.
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)
Day 8 (7 days after dose 1)
|
139.6 titer
Interval 36.1 to 539.9
|
115.2 titer
Interval 21.6 to 614.4
|
275.5 titer
Interval 62.1 to 1222.3
|
1.2 titer
Interval 0.9 to 1.6
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)
Day 29 (7 days after dose 2)
|
19.4 titer
Interval 5.8 to 64.7
|
11.0 titer
Interval 4.0 to 30.7
|
8.8 titer
Interval 3.8 to 20.6
|
1.1 titer
Interval 0.9 to 1.2
|
|
Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)
Day 50 (7 days after dose 3)
|
4.8 titer
Interval 1.8 to 13.2
|
4.0 titer
Interval 1.8 to 8.7
|
4.4 titer
Interval 2.2 to 9.0
|
0.0 titer
Confidence interval could not be calculated as there was no variation among participants in this arm.
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, and 50Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant
Baseline
|
1.2 titer
Interval 1.0 to 1.6
|
1.1 titer
Interval 1.0 to 1.3
|
1.1 titer
Interval 1.0 to 1.3
|
1.3 titer
Interval 0.7 to 2.5
|
|
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant
Day 8 (7 days after dose 1)
|
310.6 titer
Interval 76.6 to 1259.2
|
220.1 titer
Interval 38.3 to 1266.3
|
806.7 titer
Interval 192.9 to 3373.5
|
1.5 titer
Interval 0.9 to 2.6
|
|
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant
Day 29 (7 days after dose 2)
|
23.6 titer
Interval 7.1 to 78.3
|
56.1 titer
Interval 14.5 to 217.0
|
80.8 titer
Interval 31.8 to 205.0
|
1.1 titer
Interval 0.9 to 1.2
|
|
Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant
Day 50 (7 days after dose 3)
|
13.9 titer
Interval 5.0 to 38.2
|
71.2 titer
Interval 20.5 to 246.5
|
65.4 titer
Interval 17.8 to 240.2
|
1.1 titer
Interval 0.9 to 1.2
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 22 43, 50, 57 and 71Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Day 22 (pre-dose 2)
|
92.3 percentage of participants
Interval 63.97 to 99.81
|
86.7 percentage of participants
Interval 59.54 to 98.34
|
93.8 percentage of participants
Interval 69.77 to 99.84
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Day 43 (pre-dose 3)
|
100.0 percentage of participants
Interval 75.29 to 100.0
|
86.7 percentage of participants
Interval 59.54 to 98.34
|
93.8 percentage of participants
Interval 69.77 to 99.84
|
0.0 percentage of participants
Interval 0.0 to 28.49
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Day 50 (7 days after dose 3)
|
100.0 percentage of participants
Interval 73.54 to 100.0
|
93.3 percentage of participants
Interval 68.05 to 99.83
|
92.9 percentage of participants
Interval 66.13 to 99.82
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Day 57 (14 days after dose 3)
|
100.0 percentage of participants
Interval 73.54 to 100.0
|
93.3 percentage of participants
Interval 68.05 to 99.83
|
93.8 percentage of participants
Interval 69.77 to 99.84
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline
Day 71 (28 days after dose 3)
|
91.7 percentage of participants
Interval 61.52 to 99.79
|
86.7 percentage of participants
Interval 59.54 to 98.34
|
93.8 percentage of participants
Interval 69.77 to 99.84
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 22 43, 50, 57 and 71Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Day 22 (pre-dose 2)
|
69.2 percentage of participants
Interval 38.57 to 90.91
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Day 43 (pre-dose 3)
|
84.6 percentage of participants
Interval 54.55 to 98.08
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 28.49
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Day 50 (7 days after dose 3)
|
91.7 percentage of participants
Interval 61.52 to 99.79
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100. percentage of participants
Interval 76.84 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Day 57 (14 days after dose 3)
|
100.0 percentage of participants
Interval 73.54 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline
Day 71 (28 days after dose 3)
|
100.0 percentage of participants
Interval 73.54 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 79.41 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, and 50Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline
Day 8 (7 days after dose 1)
|
92.3 percentage of participants
Interval 63.97 to 99.81
|
86.7 percentage of participants
Interval 59.54 to 98.34
|
93.8 percentage of participants
Interval 69.77 to 99.84
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
|
Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline
Day 29 (7 days after dose 2)
|
76.9 percentage of participants
Interval 46.19 to 94.96
|
73.3 percentage of participants
Interval 44.9 to 92.21
|
66.7 percentage of participants
Interval 38.38 to 88.18
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline
Day 50 (7 days after dose 3)
|
50.0 percentage of participants
Interval 21.09 to 78.91
|
40.0 percentage of participants
Interval 16.34 to 67.71
|
42.9 percentage of participants
Interval 17.66 to 71.14
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, and 50Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline
Day 8 (7 days after dose 1)
|
100.0 percentage of participants
Interval 75.29 to 100.0
|
93.3 percentage of participants
Interval 68.05 to 99.83
|
93.8 percentage of participants
Interval 69.77 to 99.84
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
|
Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline
Day 29 (7 days after dose 2)
|
76.9 percentage of participants
Interval 46.19 to 94.96
|
93.3 percentage of participants
Interval 68.05 to 99.83
|
93.3 percentage of participants
Interval 68.05 to 99.83
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
|
Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline
Day 50 (7 days after dose 3)
|
83.3 percentage of participants
Interval 51.59 to 97.91
|
86.7 percentage of participants
Interval 59.54 to 98.34
|
92.9 percentage of participants
Interval 66.13 to 99.82
|
0.0 percentage of participants
Interval 0.0 to 26.46
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 22, 43, 50, 57 and 71.Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Day 22 (pre-dose 2)
|
18.8 fold-rise
Interval 7.3 to 48.0
|
23.2 fold-rise
Interval 10.5 to 51.2
|
103.1 fold-rise
Interval 46.0 to 230.8
|
0.9 fold-rise
Interval 0.8 to 1.2
|
|
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Day 43 (pre-dose 3)
|
17.8 fold-rise
Interval 7.3 to 43.2
|
19.2 fold-rise
Interval 9.3 to 40.0
|
66.8 fold-rise
Interval 30.3 to 147.5
|
0.8 fold-rise
Interval 0.6 to 1.1
|
|
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Day 50 (7 days after dose 3)
|
16.0 fold-rise
Interval 7.5 to 33.9
|
22.1 fold-rise
Interval 11.0 to 44.2
|
74.2 fold-rise
Interval 34.3 to 160.7
|
0.7 fold-rise
Interval 0.6 to 0.9
|
|
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Day 57 (14 days after dose 3)
|
21.4 fold-rise
Interval 8.8 to 52.0
|
25.4 fold-rise
Interval 11.8 to 54.5
|
72.9 fold-rise
Interval 34.3 to 154.8
|
0.9 fold-rise
Interval 0.8 to 1.1
|
|
Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline
Day 71 (28 days after dose 3)
|
20.2 fold-rise
Interval 8.1 to 49.9
|
17.5 fold-rise
Interval 7.8 to 39.3
|
66.8 fold-rise
Interval 30.3 to 147.5
|
1.1 fold-rise
Interval 0.8 to 1.4
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 22, 43, 50, 57 and 71.Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Fold-rise in Serum IgG From Baseline
Day 22 (pre-dose 2)
|
9.9 fold-rise
Interval 3.8 to 25.8
|
17.5 fold-rise
Interval 10.9 to 28.3
|
34.9 fold-rise
Interval 20.4 to 59.7
|
1.1 fold-rise
Interval 0.8 to 1.4
|
|
Geometric Mean Fold-rise in Serum IgG From Baseline
Day 43 (pre-dose 3)
|
16.9 fold-rise
Interval 6.8 to 42.0
|
23.2 fold-rise
Interval 11.7 to 45.6
|
49.4 fold-rise
Interval 27.5 to 88.7
|
1.0 fold-rise
Interval 0.7 to 1.4
|
|
Geometric Mean Fold-rise in Serum IgG From Baseline
Day 50 (7 days after dose 3)
|
17.0 fold-rise
Interval 7.0 to 41.3
|
29.2 fold-rise
Interval 16.4 to 52.0
|
45.3 fold-rise
Interval 23.8 to 86.0
|
1.1 fold-rise
Interval 0.8 to 1.4
|
|
Geometric Mean Fold-rise in Serum IgG From Baseline
Day 57 (14 days after dose 3)
|
21.4 fold-rise
Interval 9.7 to 46.8
|
35.1 fold-rise
Interval 18.7 to 65.9
|
53.8 fold-rise
Interval 30.6 to 94.6
|
1.2 fold-rise
Interval 0.8 to 1.7
|
|
Geometric Mean Fold-rise in Serum IgG From Baseline
Day 71 (28 days after dose 3)
|
22.6 fold-rise
Interval 11.1 to 46.3
|
33.5 fold-rise
Interval 16.8 to 66.7
|
49.4 fold-rise
Interval 27.1 to 90.0
|
0.8 fold-rise
Interval 0.6 to 1.2
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, and 50Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Fold-rise in ALS IgA From Baseline
Day 8 (7 days after dose 1)
|
132.3 fold-rise
Interval 35.8 to 489.4
|
87.3 fold-rise
Interval 18.6 to 410.2
|
241.9 fold-rise
Interval 53.4 to 1095.1
|
1.2 fold-rise
Interval 0.9 to 1.6
|
|
Geometric Mean Fold-rise in ALS IgA From Baseline
Day 29 (7 days after dose 2)
|
18.4 fold-rise
Interval 5.3 to 63.7
|
8.4 fold-rise
Interval 3.4 to 20.5
|
7.7 fold-rise
Interval 3.3 to 18.0
|
1.1 fold-rise
Interval 0.9 to 1.2
|
|
Geometric Mean Fold-rise in ALS IgA From Baseline
Day 50 (7 days after dose 3)
|
4.6 fold-rise
Interval 1.6 to 12.8
|
3.0 fold-rise
Interval 1.5 to 6.0
|
3.8 fold-rise
Interval 1.8 to 8.0
|
1.0 fold-rise
Confidence interval could not be calculated as there was no variation among participants in this arm at this time point.
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, and 50Population: The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.
Outcome measures
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=13 Participants
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=15 Participants
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 Participants
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 Participants
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Geometric Mean Fold-rise in ALS IgG From Baseline
Day 8 (7 days after dose 1)
|
250.9 fold-rise
Interval 62.0 to 1015.4
|
200.7 fold-rise
Interval 36.5 to 1103.6
|
708.3 fold-rise
Interval 163.3 to 3072.4
|
1.1 fold-rise
Interval 0.6 to 2.2
|
|
Geometric Mean Fold-rise in ALS IgG From Baseline
Day 29 (7 days after dose 2)
|
19.0 fold-rise
Interval 5.6 to 64.7
|
51.2 fold-rise
Interval 13.8 to 190.1
|
70.3 fold-rise
Interval 28.2 to 175.6
|
0.8 fold-rise
Interval 0.4 to 1.5
|
|
Geometric Mean Fold-rise in ALS IgG From Baseline
Day 50 (7 days after dose 3)
|
12.4 fold-rise
Interval 4.6 to 33.2
|
64.9 fold-rise
Interval 19.1 to 220.1
|
59.2 fold-rise
Interval 15.7 to 223.6
|
0.8 fold-rise
Interval 0.5 to 1.3
|
Adverse Events
Invaplex[AR-Detox] 2.5 μg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Invaplex[AR-Detox] 10 μg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Invaplex[AR-Detox] 25 μg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Invaplex[AR-Detox] 2.5 μg
n=14 participants at risk
Participants received an intramuscular injection of 2.5 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 10 μg
n=16 participants at risk
Participants received an intramuscular injection of 10 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Invaplex[AR-Detox] 25 μg
n=16 participants at risk
Participants received an intramuscular injection of 25 μg Invaplex\[AR-DETOX\] vaccine on Days 1, 22, and 43.
|
Placebo
n=12 participants at risk
Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
4/16 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
4/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • From first dose up to 28 days following the third immunization (71 days)
|
31.2%
5/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
3/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Fatigue
|
28.6%
4/14 • From first dose up to 28 days following the third immunization (71 days)
|
37.5%
6/16 • From first dose up to 28 days following the third immunization (71 days)
|
50.0%
8/16 • From first dose up to 28 days following the third immunization (71 days)
|
33.3%
4/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Malaise
|
21.4%
3/14 • From first dose up to 28 days following the third immunization (71 days)
|
50.0%
8/16 • From first dose up to 28 days following the third immunization (71 days)
|
43.8%
7/16 • From first dose up to 28 days following the third immunization (71 days)
|
16.7%
2/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Pyrexia
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Vaccination site erythema
|
100.0%
14/14 • From first dose up to 28 days following the third immunization (71 days)
|
62.5%
10/16 • From first dose up to 28 days following the third immunization (71 days)
|
56.2%
9/16 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
3/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Vaccination site induration
|
42.9%
6/14 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
4/16 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Vaccination site pain
|
92.9%
13/14 • From first dose up to 28 days following the third immunization (71 days)
|
100.0%
16/16 • From first dose up to 28 days following the third immunization (71 days)
|
100.0%
16/16 • From first dose up to 28 days following the third immunization (71 days)
|
16.7%
2/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Vaccination site pruritus
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
31.2%
5/16 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
4/16 • From first dose up to 28 days following the third immunization (71 days)
|
16.7%
2/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
General disorders
Vaccination site swelling
|
14.3%
2/14 • From first dose up to 28 days following the third immunization (71 days)
|
37.5%
6/16 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
4/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
16.7%
2/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Investigations
Haemoglobin decreased
|
42.9%
6/14 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Metabolism and nutrition disorders
Appetite disorder
|
14.3%
2/14 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
21.4%
3/14 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
3/14 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
12.5%
2/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
18.8%
3/16 • From first dose up to 28 days following the third immunization (71 days)
|
25.0%
3/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • From first dose up to 28 days following the third immunization (71 days)
|
50.0%
8/16 • From first dose up to 28 days following the third immunization (71 days)
|
37.5%
6/16 • From first dose up to 28 days following the third immunization (71 days)
|
33.3%
4/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
6.2%
1/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
8.3%
1/12 • From first dose up to 28 days following the third immunization (71 days)
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/16 • From first dose up to 28 days following the third immunization (71 days)
|
0.00%
0/12 • From first dose up to 28 days following the third immunization (71 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place