Trial Outcomes & Findings for Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults (NCT NCT03722472)
NCT ID: NCT03722472
Last Updated: 2023-06-01
Results Overview
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
7 days following each injection
Results posted on
2023-06-01
Participant Flow
Participant milestones
| Measure |
Single-vial Presentation ID93 + GLA-SE
Thermostable lyophilized single-vial presentation of ID93 + GLA-SE (2 µg ID93, 5 µg GLA) given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
Non-thermostable two-vial presentation of ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
Baseline characteristics by cohort
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days following each injectionPopulation: Safety population (n=48). All subjects receiving at least one study injection.
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Local Injection Site Reactogenicity
|
22 participants
|
21 participants
|
PRIMARY outcome
Timeframe: 7 days following each injectionPopulation: Safety population (n=48). All subjects receiving at least one study injection.
The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Systemic Reactogenicity
|
9 participants
|
12 participants
|
PRIMARY outcome
Timeframe: Day 0 - 84Population: Safety population (n=48). All subjects received at least one study injection.
The number of subjects spontaneously reporting adverse events from Day 0 through Day 84.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
All Adverse Events
|
23 participants
|
24 participants
|
PRIMARY outcome
Timeframe: Day 0 - 421Population: Safety population (n=48). All subjects received at least one study injection.
The number of serious adverse events considered related to any of the study injections reported at any point during the study period.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Serious Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0, 14, 56, 70, 84, and 224Population: Immunogenicity population: all eligible subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Total IgG antibody ELISA: Responder rate is defined as the proportion of subjects with at least a 4-fold increase from baseline in IgG antibody titer for ID93 antigen.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
IgG Antibody Response Rate
Day 14 Responder rate
|
30.4 percentage of participants
Interval 13.21 to 52.92
|
25.0 percentage of participants
Interval 9.77 to 46.71
|
|
IgG Antibody Response Rate
Day 56 Responder rate
|
60.9 percentage of participants
Interval 38.54 to 80.29
|
40.9 percentage of participants
Interval 20.71 to 63.65
|
|
IgG Antibody Response Rate
Day 70 Responder rate
|
100 percentage of participants
Interval 85.18 to 100.0
|
90.9 percentage of participants
Interval 70.84 to 98.88
|
|
IgG Antibody Response Rate
Day 84 Responder rate
|
90.9 percentage of participants
Interval 70.84 to 98.88
|
95.5 percentage of participants
Interval 77.16 to 99.88
|
|
IgG Antibody Response Rate
Day 224 Responder rate
|
85.0 percentage of participants
Interval 62.11 to 96.79
|
63.6 percentage of participants
Interval 40.66 to 82.8
|
SECONDARY outcome
Timeframe: Days 0, 14, 56, 70, 84, and 224Population: All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Total IgG mean endpoint titer for ID93
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
IgG Antibody Response Magnitude
Day 0 Geometric Mean MEPT
|
57 titer
Interval 49.0 to 66.0
|
74 titer
Interval 45.0 to 123.0
|
|
IgG Antibody Response Magnitude
Day 14 Geometric Mean MEPT
|
147 titer
Interval 83.0 to 260.0
|
140 titer
Interval 94.0 to 209.0
|
|
IgG Antibody Response Magnitude
Day 56 Geometric Mean MEPT
|
250 titer
Interval 154.0 to 405.0
|
259 titer
Interval 126.0 to 530.0
|
|
IgG Antibody Response Magnitude
Day 70 Geometric Mean MEPT
|
10868 titer
Interval 5971.0 to 19780.0
|
2583 titer
Interval 1608.0 to 4147.0
|
|
IgG Antibody Response Magnitude
Day 84 Geometric Mean MEPT
|
5592 titer
Interval 2753.0 to 11362.0
|
2522 titer
Interval 1711.0 to 3716.0
|
|
IgG Antibody Response Magnitude
Day 224 Geometric Mean MEPT
|
913 titer
Interval 510.0 to 1634.0
|
445 titer
Interval 273.0 to 726.0
|
SECONDARY outcome
Timeframe: Days 0, 14, 56, 70, 84, and 224Population: All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
PBMC ELISpot: IFN-γ response to the ID93 antigen. Responder status is determined by the SCHARP method.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Cytokine Response
Day 0 Responder rate
|
13.0 percentage of participants
Interval 2.78 to 33.59
|
20.0 percentage of participants
Interval 6.83 to 40.7
|
|
Cytokine Response
Day 14 Responder rate
|
45.5 percentage of participants
Interval 24.39 to 67.79
|
32.0 percentage of participants
Interval 14.95 to 53.5
|
|
Cytokine Response
Day 56 Responder rate
|
34.8 percentage of participants
Interval 16.38 to 57.27
|
31.8 percentage of participants
Interval 13.86 to 54.87
|
|
Cytokine Response
Day 70 Responder rate
|
69.6 percentage of participants
Interval 47.08 to 86.79
|
76.2 percentage of participants
Interval 52.83 to 91.79
|
|
Cytokine Response
DAY 84 Responder rate
|
68.2 percentage of participants
Interval 45.13 to 86.14
|
66.7 percentage of participants
Interval 43.03 to 85.41
|
|
Cytokine Response
Day 224 Responder rate
|
65 percentage of participants
Interval 40.78 to 84.61
|
52.6 percentage of participants
Interval 28.86 to 75.55
|
SECONDARY outcome
Timeframe: Days 0, 14, 56, 70, 84 and 224Population: All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
PBMC ELISpot: IL-10 response to the ID93 antigen. Responder status is determined by the SCHARP method.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Cytokine Response
Day 0 Responder rate
|
4.3 percentage of participants
Interval 0.11 to 21.95
|
8.0 percentage of participants
Interval 0.98 to 26.03
|
|
Cytokine Response
Day 14 Responder rate
|
0 percentage of participants
Interval 0.0 to 15.44
|
4.3 percentage of participants
Interval 0.11 to 21.95
|
|
Cytokine Response
Day 56 Responder rate
|
4.3 percentage of participants
Interval 0.11 to 21.95
|
4.5 percentage of participants
Interval 0.12 to 22.84
|
|
Cytokine Response
Day 70 Responder rate
|
30.4 percentage of participants
Interval 13.21 to 52.92
|
0 percentage of participants
Interval 0.0 to 16.84
|
|
Cytokine Response
Day 84 Responder rate
|
18.2 percentage of participants
Interval 5.19 to 40.28
|
10.5 percentage of participants
Interval 1.3 to 33.14
|
|
Cytokine Response
Day 224 Responder rate
|
10.0 percentage of participants
Interval 1.23 to 31.7
|
0 percentage of participants
Interval 0.0 to 18.53
|
SECONDARY outcome
Timeframe: Days 0, 7, 14, 56, 63, 70, 84 and 224Population: All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
PBMC ICS: Responder Rate of the "Any Two" CD4 T cell responses to the ID93 antigen; CD4 T cells producing 1 or more cytokines (IFN-γ, TNF, IL-2, IL-4, IL-21 and CD154) simultaneously in response to stimulation with the ID93 antigen as measured by intracellular cytokine staining of PBMCs.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
T Cell Response
Day 0 Responder rate
|
4.3 percentage of participants
Interval 0.11 to 21.95
|
4.0 percentage of participants
Interval 0.1 to 20.35
|
|
T Cell Response
Day 7 Responder rate
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
4.0 percentage of participants
Interval 0.1 to 20.35
|
|
T Cell Response
Day 14 Responder rate
|
15.0 percentage of participants
Interval 3.21 to 37.89
|
4.2 percentage of participants
Interval 0.11 to 21.12
|
|
T Cell Response
Day 56 Responder rate
|
13.6 percentage of participants
Interval 2.91 to 34.91
|
0 percentage of participants
Interval 0.0 to 16.84
|
|
T Cell Response
Day 63 Responder rate
|
36.4 percentage of participants
Interval 17.2 to 59.34
|
13.6 percentage of participants
Interval 2.91 to 34.91
|
|
T Cell Response
Day 70 Responder rate
|
59.1 percentage of participants
Interval 36.35 to 79.29
|
38.1 percentage of participants
Interval 18.11 to 61.56
|
|
T Cell Response
Day 84 Responder rate
|
50.0 percentage of participants
Interval 27.2 to 72.8
|
30.0 percentage of participants
Interval 11.89 to 54.28
|
|
T Cell Response
Day 224 Responder rate
|
31.3 percentage of participants
Interval 11.02 to 58.66
|
26.3 percentage of participants
Interval 9.15 to 51.2
|
SECONDARY outcome
Timeframe: Days 0, 7, 14, 56, 63, 70, 84 and 224.Population: All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
PBMC ICS: Responder Rate of the "Any Two" CD8 T cell responses to the ID93 antigen; CD8 T cells producing 1 or more cytokines (IFN-γ, TNF, IL-2, IL-4, IL-21 and CD154) simultaneously in response to stimulation with the ID93 antigen as measured by intracellular cytokine staining of PBMCs.
Outcome measures
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 Participants
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 Participants
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
T Cell Response
Day 0 Responder rate
|
0 percentage of participants
Interval 0.0 to 14.82
|
0 percentage of participants
Interval 0.0 to 13.72
|
|
T Cell Response
Day 7 Responder rate
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
0 percentage of participants
Interval 0.0 to 13.72
|
|
T Cell Response
Day 14 Responder rate
|
15.0 percentage of participants
Interval 3.21 to 37.89
|
0 percentage of participants
Interval 0.0 to 14.25
|
|
T Cell Response
Day 56 Responder rate
|
4.5 percentage of participants
Interval 0.12 to 22.84
|
0 percentage of participants
Interval 0.0 to 16.84
|
|
T Cell Response
Day 63 Responder rate
|
4.5 percentage of participants
Interval 0.12 to 22.84
|
9.1 percentage of participants
Interval 1.12 to 29.16
|
|
T Cell Response
Day 70 Responder rate
|
0 percentage of participants
Interval 0.0 to 15.44
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
|
T Cell Response
Day 84 Responder rate
|
0 percentage of participants
Interval 0.0 to 16.84
|
5.0 percentage of participants
Interval 0.13 to 24.87
|
|
T Cell Response
Day 224 Responder rate
|
6.3 percentage of participants
Interval 0.16 to 30.23
|
15.8 percentage of participants
Interval 3.38 to 39.58
|
Adverse Events
Single-vial Presentation ID93 + GLA-SE
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Two-vial Presentation ID93 + GLA-SE
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-vial Presentation ID93 + GLA-SE
n=23 participants at risk
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) \[lyophilized, single-vial\] given as two intramuscular (IM) injections on Days 0 and 56.
|
Two-vial Presentation ID93 + GLA-SE
n=25 participants at risk
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) \[two-vial presentation\] given as two intramuscular (IM) injections on Days 0 and 56.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
4.0%
1/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
General disorders
Fatigue
|
26.1%
6/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
40.0%
10/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
Nervous system disorders
Headache
|
17.4%
4/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
28.0%
7/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
General disorders
Injection site pain
|
95.7%
22/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
84.0%
21/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
General disorders
Injection site induration
|
13.0%
3/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
0.00%
0/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
3/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
20.0%
5/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
Investigations
Haemoglobin decreased
|
4.3%
1/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
20.0%
5/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.4%
4/23 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
8.0%
2/25 • 421 days
Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
|
Additional Information
Christopher Fox PhD
Access to Advanced Health Institute (AAHI)
Phone: (206) 381-0883
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place