Trial Outcomes & Findings for Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine (NCT NCT05027932)
NCT ID: NCT05027932
Last Updated: 2025-04-08
Results Overview
Type of SAEs through day V2D28.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
V2D28 (Day 56)
Results posted on
2025-04-08
Participant Flow
Participants were identified and recruited from the community through multiple methodologies including local advertisement, direct contact of prior study participants, and word of mouth advertisement. Seventy-eight participants were screened between May 2022 and October 2022 on a separate screening protocol (11-I-0183).
Forty-five participants were enrolled and randomized to the three study arms.
Participant milestones
| Measure |
Group A
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
Received Dose 1
|
15
|
15
|
15
|
|
Overall Study
Received Dose 2
|
15
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Group A
n=15 Participants
15 participants receiving IM BPL1357 and IN Placebo.
|
Group B
n=15 Participants
15 participants receiving IN BPL1357 and IM Placebo.
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
30.3 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
27.5 years
STANDARD_DEVIATION 6.0 • n=27 Participants
|
30.6 years
STANDARD_DEVIATION 8.6 • n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: V2D28 (Day 56)Type of SAEs through day V2D28.
Outcome measures
| Measure |
Group A
n=15 Participants
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=15 Participants
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Safety - Serious Adverse Event
|
0 SAEs
|
0 SAEs
|
0 SAEs
|
PRIMARY outcome
Timeframe: V2D28 (Day 56)Type and severity (by grading) of intervention-related AEs through day V2D28.
Outcome measures
| Measure |
Group A
n=15 Participants
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=15 Participants
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Safety - Adverse Events
Fatigue
|
10 Participants
|
8 Participants
|
9 Participants
|
|
Safety - Adverse Events
Injection Site Pain
|
14 Participants
|
6 Participants
|
0 Participants
|
|
Safety - Adverse Events
Cough
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety - Adverse Events
Hypokalemia
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety - Adverse Events
Hypophosphatemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Vertigo
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
WBC decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
WBC increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Headache
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Safety - Adverse Events
Myalgia
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Safety - Adverse Events
Sore Throat
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Safety - Adverse Events
Sneezing
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Safety - Adverse Events
Arthralgia
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety - Adverse Events
Hoarseness
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety - Adverse Events
Rhinorrhea
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Safety - Adverse Events
Nasal congestion
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Safety - Adverse Events
Neutrophil count decreased
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Safety - Adverse Events
Chills
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Safety - Adverse Events
Nausea
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety - Adverse Events
Decreased appetite
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety - Adverse Events
Hemoglobin decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety - Adverse Events
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Diarrhea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Erythema
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Eye discomfort
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Hyperglycemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Injection site ecchymosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Migraine
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Muscle weakness lower limb
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Numbness
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Paresthesia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: V2D182 (Day 210)Type of SAEs through day V2D182
Outcome measures
| Measure |
Group A
n=15 Participants
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=15 Participants
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Safety - Serious Adverse Event
|
0 SAEs
|
0 SAEs
|
0 SAEs
|
SECONDARY outcome
Timeframe: V2D182 (Day 210)Type and severity (by grading) of AEs through day V2D182
Outcome measures
| Measure |
Group A
n=15 Participants
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=15 Participants
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Safety - Adverse Events
Injection site ecchymosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Migraine
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Muscle weakness lower limb
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Numbness
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Eye discomfort
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Vertigo
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Paresthesia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
WBC decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
WBC increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Fatigue
|
10 Participants
|
8 Participants
|
9 Participants
|
|
Safety - Adverse Events
Injection site pain
|
14 Participants
|
6 Participants
|
0 Participants
|
|
Safety - Adverse Events
Headache
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Safety - Adverse Events
Myalgia
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Safety - Adverse Events
Sore throat
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Safety - Adverse Events
Sneezing
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Safety - Adverse Events
Arthralgia
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety - Adverse Events
Hoarseness
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety - Adverse Events
Rhinorrhea
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Safety - Adverse Events
Nasal congestion
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Safety - Adverse Events
Neutrophil count decreased
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Safety - Adverse Events
Chills
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Safety - Adverse Events
Cough
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety - Adverse Events
Hypokalemia
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety - Adverse Events
Nausea
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety - Adverse Events
Decreased appetite
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety - Adverse Events
Hemoglobin decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety - Adverse Events
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Adverse Events
Diarrhea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Erythema
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Adverse Events
Hyperglycemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Adverse Events
Hypophosphatemia
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: V2D28 (Day 56)Population: One participant in Group A missed their V2D28 visit and did not provide samples for analysis at this timepoints. One participant in group B withdrew consent to use samples after study completion.
Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V2D28
Outcome measures
| Measure |
Group A
n=14 Participants
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=14 Participants
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Serum Anti-H7 IgG
|
638 ELISA Titers
95% Confidence Interval 524 • Interval 452.0 to 902.0
|
169 ELISA Titers
95% Confidence Interval 421 • Interval 92.0 to 311.0
|
141 ELISA Titers
95% Confidence Interval 123 • Interval 86.0 to 231.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Nasal Anti-H1 IgA
|
0.446 ELISA Titers
95% Confidence Interval 0.520 • Interval 0.288 to 0.69
|
0.556 ELISA Titers
95% Confidence Interval 0.325 • Interval 0.411 to 0.754
|
0.504 ELISA Titers
95% Confidence Interval 0.223 • Interval 0.375 to 0.676
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Nasal Anti-H5 IgA
|
0.213 ELISA Titers
95% Confidence Interval 0.332 • Interval 0.132 to 0.343
|
0.377 ELISA Titers
95% Confidence Interval 0.345 • Interval 0.242 to 0.589
|
0.264 ELISA Titers
95% Confidence Interval 0.291 • Interval 0.168 to 0.415
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Serum Anti-H1 IgG
|
2765 ELISA Titers
95% Confidence Interval 4339 • Interval 1580.0 to 4839.0
|
2093 ELISA Titers
95% Confidence Interval 2519 • Interval 1309.0 to 3345.0
|
1776 ELISA Titers
95% Confidence Interval 1514 • Interval 1223.0 to 2580.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Serum Anti-H3 IgG
|
1104 ELISA Titers
95% Confidence Interval 973 • Interval 737.0 to 1653.0
|
379 ELISA Titers
95% Confidence Interval 686 • Interval 202.0 to 710.0
|
333 ELISA Titers
95% Confidence Interval 242 • Interval 219.0 to 505.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Serum Anti-H5 IgG
|
1010 ELISA Titers
95% Confidence Interval 1425 • Interval 632.0 to 1615.0
|
365 ELISA Titers
95% Confidence Interval 310 • Interval 234.0 to 569.0
|
284 ELISA Titers
95% Confidence Interval 145 • Interval 210.0 to 386.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Nasal Anti-H3 IgA
|
0.525 ELISA Titers
95% Confidence Interval 0.218 • Interval 0.42 to 0.655
|
0.564 ELISA Titers
95% Confidence Interval 0.279 • Interval 0.438 to 0.726
|
0.543 ELISA Titers
95% Confidence Interval 0.267 • Interval 0.418 to 0.706
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Nasal Anti-H7 IgA
|
0.279 ELISA Titers
95% Confidence Interval 0.316 • Interval 0.185 to 0.421
|
0.357 ELISA Titers
95% Confidence Interval 0.131 • Interval 0.285 to 0.446
|
0.329 ELISA Titers
95% Confidence Interval 0.210 • Interval 0.236 to 0.46
|
SECONDARY outcome
Timeframe: V2D28 (Day 56)Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V2D28
Outcome measures
| Measure |
Group A
n=14 Participants
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=14 Participants
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 Participants
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Serum Anti-N9 IgG
|
25 ELISA Titers
Interval 13.0 to 46.0
|
12 ELISA Titers
Interval 10.0 to 16.0
|
13 ELISA Titers
Interval 10.0 to 17.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Nasal Anti-N1 IgA
|
0.171 ELISA Titers
Interval 0.111 to 0.264
|
0.405 ELISA Titers
Interval 0.264 to 0.622
|
0.308 ELISA Titers
Interval 0.169 to 0.561
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Serum Anti-N1 IgG
|
222 ELISA Titers
Interval 119.0 to 415.0
|
266 ELISA Titers
Interval 138.0 to 513.0
|
282 ELISA Titers
Interval 184.0 to 432.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Serum Anti-N3 IgG
|
43 ELISA Titers
Interval 19.0 to 100.0
|
30 ELISA Titers
Interval 17.0 to 52.0
|
20 ELISA Titers
Interval 13.0 to 29.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Serum Anti-N8 IgG
|
25 ELISA Titers
Interval 15.0 to 44.0
|
15 ELISA Titers
Interval 10.0 to 22.0
|
23 ELISA Titers
Interval 13.0 to 41.0
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Nasal Anti-N3 IgA
|
0.091 ELISA Titers
Interval 0.076 to 0.11
|
0.132 ELISA Titers
Interval 0.091 to 0.19
|
0.142 ELISA Titers
Interval 0.089 to 0.226
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Nasal Anti-N8 IgA
|
0.139 ELISA Titers
Interval 0.102 to 0.19
|
0.238 ELISA Titers
Interval 0.165 to 0.343
|
0.288 ELISA Titers
Interval 0.178 to 0.464
|
|
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Nasal Anti-N9 IgA
|
0.124 ELISA Titers
Interval 0.095 to 0.162
|
0.164 ELISA Titers
Interval 0.164 to 0.252
|
0.240 ELISA Titers
Interval 0.152 to 0.379
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=15 participants at risk
15 participants receiving IM BPL1357 and IN Placebo
|
Group B
n=15 participants at risk
15 participants receiving IN BPL1357 and IM Placebo
|
Group C
n=15 participants at risk
15 participants receiving IM and IN placebo
|
|---|---|---|---|
|
General disorders
Fatigue
|
80.0%
12/15 • 7 months
|
60.0%
9/15 • 7 months
|
66.7%
10/15 • 7 months
|
|
General disorders
Injection site pain
|
100.0%
15/15 • 7 months
|
40.0%
6/15 • 7 months
|
40.0%
6/15 • 7 months
|
|
Nervous system disorders
Headache
|
66.7%
10/15 • 7 months
|
46.7%
7/15 • 7 months
|
60.0%
9/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
53.3%
8/15 • 7 months
|
40.0%
6/15 • 7 months
|
60.0%
9/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
5/15 • 7 months
|
46.7%
7/15 • 7 months
|
66.7%
10/15 • 7 months
|
|
Investigations
Respiratory rate
|
33.3%
5/15 • 7 months
|
66.7%
10/15 • 7 months
|
40.0%
6/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15 • 7 months
|
46.7%
7/15 • 7 months
|
46.7%
7/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.7%
7/15 • 7 months
|
33.3%
5/15 • 7 months
|
46.7%
7/15 • 7 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
5/15 • 7 months
|
53.3%
8/15 • 7 months
|
33.3%
5/15 • 7 months
|
|
Investigations
Bradycardia
|
26.7%
4/15 • 7 months
|
33.3%
5/15 • 7 months
|
33.3%
5/15 • 7 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
3/15 • 7 months
|
33.3%
5/15 • 7 months
|
40.0%
6/15 • 7 months
|
|
Investigations
Hemoglobin decreased
|
40.0%
6/15 • 7 months
|
20.0%
3/15 • 7 months
|
26.7%
4/15 • 7 months
|
|
Investigations
CPK increased
|
13.3%
2/15 • 7 months
|
33.3%
5/15 • 7 months
|
33.3%
5/15 • 7 months
|
|
Investigations
Neutrophil count decreased
|
20.0%
3/15 • 7 months
|
20.0%
3/15 • 7 months
|
40.0%
6/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
20.0%
3/15 • 7 months
|
33.3%
5/15 • 7 months
|
26.7%
4/15 • 7 months
|
|
General disorders
Chills
|
20.0%
3/15 • 7 months
|
26.7%
4/15 • 7 months
|
26.7%
4/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • 7 months
|
20.0%
3/15 • 7 months
|
40.0%
6/15 • 7 months
|
|
Infections and infestations
COVID-19
|
20.0%
3/15 • 7 months
|
6.7%
1/15 • 7 months
|
33.3%
5/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.7%
1/15 • 7 months
|
33.3%
5/15 • 7 months
|
20.0%
3/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • 7 months
|
26.7%
4/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • 7 months
|
20.0%
3/15 • 7 months
|
13.3%
2/15 • 7 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • 7 months
|
20.0%
3/15 • 7 months
|
26.7%
4/15 • 7 months
|
|
Infections and infestations
Upper respiratory infection
|
26.7%
4/15 • 7 months
|
13.3%
2/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
General disorders
Fever
|
6.7%
1/15 • 7 months
|
20.0%
3/15 • 7 months
|
13.3%
2/15 • 7 months
|
|
Investigations
Hyponatremia
|
13.3%
2/15 • 7 months
|
20.0%
3/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Investigations
Hypophosphatemia
|
13.3%
2/15 • 7 months
|
0.00%
0/15 • 7 months
|
26.7%
4/15 • 7 months
|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
26.7%
4/15 • 7 months
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 7 months
|
13.3%
2/15 • 7 months
|
13.3%
2/15 • 7 months
|
|
Gastrointestinal disorders
Abdominal cramps
|
20.0%
3/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Investigations
WBC decreased
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
20.0%
3/15 • 7 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • 7 months
|
13.3%
2/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
13.3%
2/15 • 7 months
|
|
Eye disorders
Eye discomfort
|
0.00%
0/15 • 7 months
|
13.3%
2/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
General disorders
Feverish
|
13.3%
2/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.3%
2/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • 7 months
|
13.3%
2/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Investigations
WBC increased
|
13.3%
2/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
General disorders
Chest pain
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
13.3%
2/15 • 7 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Investigations
Rhinovirus infection
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
13.3%
2/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Anterior cruciate ligament tear
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Investigations
BUN increased
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Eye disorders
Cotton wool spots
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Social circumstances
Dental implant user
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Nervous system disorders
Difficulty thinking
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
General disorders
Injection site ecchymosis
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
General disorders
Injection site itching
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Itchy throat
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Nervous system disorders
Loss of smell
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Meniscus tear of knee
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Reproductive system and breast disorders
Menstrual irregularity
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Nervous system disorders
Numbness
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
General disorders
Pain
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Nervous system disorders
Paresthesia
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Injury, poisoning and procedural complications
Puncture wound
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Nervous system disorders
Smell alteration
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Nervous system disorders
Taste alteration
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Investigations
Uric acid high
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
General disorders
Venipuncture site bruise
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
|
Investigations
Weight loss
|
0.00%
0/15 • 7 months
|
6.7%
1/15 • 7 months
|
0.00%
0/15 • 7 months
|
Additional Information
Luca Giurgea
Clinical Studies Unit, Laboratory of Infectious Diseases, NIAID, NIH
Phone: 301-538-5235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place