Trial Outcomes & Findings for COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies (NCT NCT05028374)
NCT ID: NCT05028374
Last Updated: 2023-12-20
Results Overview
Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccine
Results posted on
2023-12-20
Participant Flow
Participant milestones
| Measure |
Cohort 1
Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 2
Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 3
Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
16
|
|
Overall Study
COMPLETED
|
52
|
50
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Cohort 1
n=52 Participants
Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 2
n=51 Participants
Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 3
n=16 Participants
Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
63.5 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
70 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccinePopulation: Participants who received a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly.
Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
Outcome measures
| Measure |
Cohort 1
n=52 Participants
Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 2
n=50 Participants
Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 3
n=16 Participants
Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
|
|---|---|---|---|
|
Observed Response Rate of Anti-SARS-CoV2 Antibody Seroconversion.
|
29 Participants
|
28 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: measured 28 days (+/- 3 days) following a booster dose of the Moderna COVID-19 vaccine.Population: Participants who received a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly.
A STRONG POSITIVE response is defined in this trial as an anti-SARS-CoV2 IgG antibody titer of at least 2 S/CO 28 days (+/- 3 days) following vaccine administration
Outcome measures
| Measure |
Cohort 1
n=52 Participants
Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 2
n=50 Participants
Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 3
n=16 Participants
Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
|
|---|---|---|---|
|
Observed Rate of STRONG POSITIVE Anti-SARS-CoV2 Antibody Response
|
27 Participants
|
23 Participants
|
15 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 48 other events
Deaths: 6 deaths
Cohort 2
Serious events: 0 serious events
Other events: 47 other events
Deaths: 4 deaths
Cohort 3
Serious events: 1 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1
n=52 participants at risk
Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 2
n=50 participants at risk
Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 3
n=16 participants at risk
Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
Other adverse events
| Measure |
Cohort 1
n=52 participants at risk
Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 2
n=50 participants at risk
Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
|
Cohort 3
n=16 participants at risk
Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
4.0%
2/50 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Cardiac disorders
Cardiac disorders - Other
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Eye disorders
Blurred vision
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Eye disorders
Eye disorders - Other
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Eye disorders
Eye pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
4/52 • Number of events 4 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
4.0%
2/50 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Nausea
|
11.5%
6/52 • Number of events 7 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.0%
3/50 • Number of events 6 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
12.5%
2/16 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
12.5%
2/16 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Chills
|
7.7%
4/52 • Number of events 4 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Edema limbs
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Fatigue
|
23.1%
12/52 • Number of events 13 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
40.0%
20/50 • Number of events 21 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
50.0%
8/16 • Number of events 8 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Fever
|
5.8%
3/52 • Number of events 3 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.0%
3/50 • Number of events 3 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
25.0%
4/16 • Number of events 5 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Injection site reaction
|
69.2%
36/52 • Number of events 37 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
80.0%
40/50 • Number of events 43 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
100.0%
16/16 • Number of events 16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Irritability
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Localized edema
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
General disorders
Pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Investigations
Creatinine increased
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Investigations
Investigations - Other
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Investigations
Neutrophil count decreased
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.8%
3/52 • Number of events 3 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
3/52 • Number of events 3 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.2%
10/52 • Number of events 10 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
24.0%
12/50 • Number of events 13 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
50.0%
8/16 • Number of events 8 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.0%
3/50 • Number of events 3 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Nervous system disorders
Headache
|
11.5%
6/52 • Number of events 6 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
14.0%
7/50 • Number of events 8 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
2.0%
1/50 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
4.0%
2/50 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Vascular disorders
Flushing
|
0.00%
0/52 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
6.2%
1/16 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
|
Vascular disorders
Hypotension
|
3.8%
2/52 • Number of events 2 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/50 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
0.00%
0/16 • Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place