Trial Outcomes & Findings for HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I) (NCT NCT03685708)
NCT ID: NCT03685708
Last Updated: 2022-02-08
Results Overview
Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
6 months after the first vaccine administration
Results posted on
2022-02-08
Participant Flow
A total of 78 participants were assessed for eligibility and consented. 76 participants met eligibility criteria.
Participant milestones
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
46
|
|
Overall Study
COMPLETED
|
13
|
16
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
9
|
Reasons for withdrawal
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Screen Fail
|
0
|
1
|
1
|
|
Overall Study
COVID 19 Pandemic
|
1
|
1
|
6
|
|
Overall Study
Disease Progression
|
0
|
0
|
1
|
Baseline Characteristics
HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
Baseline characteristics by cohort
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
n=14 Participants
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
n=18 Participants
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
n=46 Participants
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Total
n=78 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
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months after the first vaccine administrationPopulation: All participants that completed the 2 doses vaccine series and blood draws. 8 participants could not complete laboratory assessments due to COVID pandemic.
Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
Outcome measures
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
n=11 Participants
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
n=15 Participants
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
n=32 Participants
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Number of Participants With HEPLISAV-B Seroprotective Titer (Anti-HBs 10mIU/mL)
|
0 Participants
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 months after the first vaccine administrationDetermine the safety of the HEPLISAV-B vaccine among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
Outcome measures
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
n=14 Participants
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
n=18 Participants
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
n=46 Participants
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Number of Participants That Experienced Serious Adverse Events Following HEPLISAV-B Vaccine Among CLL Patients
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months after the first vaccine administrationDetermine the tolerability of the HEPLISAV-B vaccine among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
Outcome measures
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
n=14 Participants
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
n=18 Participants
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
n=46 Participants
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Number of Participants That Did Not Complete Study Due to Intolerance of the HEPLISAV-B Vaccine Among CLL Patients.
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
n=14 participants at risk
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
n=18 participants at risk
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
n=46 participants at risk
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
2.2%
1/46 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
Other adverse events
| Measure |
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
n=14 participants at risk
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
n=18 participants at risk
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
n=46 participants at risk
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine \[Recombinant \], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
5.6%
1/18 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
15.2%
7/46 • Number of events 7 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Vaccination site lymphadenopathy
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
8.7%
4/46 • Number of events 6 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
5.6%
1/18 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
6/14 • Number of events 10 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
27.8%
5/18 • Number of events 9 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
41.3%
19/46 • Number of events 30 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
5.6%
1/18 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
6.5%
3/46 • Number of events 3 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
47.8%
22/46 • Number of events 35 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
5.6%
1/18 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
5.6%
1/18 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.4%
3/14 • Number of events 6 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
44.4%
8/18 • Number of events 12 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
43.5%
20/46 • Number of events 26 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Fever
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
8.7%
4/46 • Number of events 5 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
1/14 • Number of events 3 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
16.7%
3/18 • Number of events 3 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
10.9%
5/46 • Number of events 6 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Chills
|
14.3%
2/14 • Number of events 2 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
5.6%
1/18 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
19.6%
9/46 • Number of events 12 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Edema limbs
|
21.4%
3/14 • Number of events 3 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
11.1%
2/18 • Number of events 4 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
21.7%
10/46 • Number of events 11 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Fatigue
|
35.7%
5/14 • Number of events 11 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
44.4%
8/18 • Number of events 13 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
43.5%
20/46 • Number of events 36 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Flu like symptoms
|
14.3%
2/14 • Number of events 4 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
23.9%
11/46 • Number of events 19 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Injection site reaction
|
14.3%
2/14 • Number of events 2 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
38.9%
7/18 • Number of events 9 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
17.4%
8/46 • Number of events 13 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
General disorders
Pain
|
85.7%
12/14 • Number of events 32 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
88.9%
16/18 • Number of events 32 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
76.1%
35/46 • Number of events 98 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.1%
1/14 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/18 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/46 • Events will be collected for 7 days following the first and second vaccine dose and followed until resolution
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
Additional Information
Christopher Pleyer, M.D. Principal Investigator, NIH, NHLBI
National Institutes of Health (NIH) / The National Heart, Lung, and Blood Institute (NHLBI)
Phone: 510.709.6649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place