HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT03685708
Collaborator
(none)
78
Enrollment
1
Location
3
Arms
24.3
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

People with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) tend to get infections more easily. This is because their immune systems are weakened. Hepatitis B is a virus that can be transmitted when body fluids from an infected person enter the body of an uninfected person. This virus can be dangerous for people with leukemia and lymphoma. HEPLISAV-B is a new hepatitis B vaccine. Researchers want to see if it can protect people with CLL/SLL from getting hepatitis B.

Objective:

To learn how HEPLISAV-B works in people who have CLL or SLL.

Eligibility:

Adults 18 years and older with CLL (or SLL). They must be getting no treatment for their CLL, or getting ibrutinib or acalabrutinib for it.

Design:

This study lasts 6 months from the date of first vaccination.

Participants may be screened with:

Physical exam

Blood tests

Pregnancy test

Visit 1

Participants will get blood drawn and the study vaccine. It will be given as an injection. If they get any symptoms within 7 days of the vaccine, they will write them in a diary.

Visit 2

After 3 months, participants will come back to the NIH to get another blood draw and the second vaccine dose.

Visit 3

Participants will return 3 months after the second vaccine dose was given. They will have blood drawn.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: HEPLISAV-B
Phase 2

Detailed Description

This study aims to determine the HEPLISAV-B hepatitis B vaccine efficacy in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) lymphocytic patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I) therapy. (Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified).

Key Eligibility Criteria:
  1. Diagnosis of CLL

  2. Cohort 1: Treatment naive CLL or SLL patients

  3. Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose

  4. Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose

  5. No known active or past hepatitis B infection

  6. No history of prior hepatitis B virus vaccination (approved or investigational)

  7. Age greater greater than or equal to 18 years.

  8. ECOG performance status of 0-1

Design:

Patients with CLL will enroll on the study for the purpose of determining the HEPLISAV-B vaccine efficacy in patients who are treatment naive ore receiving BTK-I therapy. A series of 2 doses of HEPLISAV-B will be given on a 0- and 3- month schedule by intramuscular injection. Subjects will be followed at regular intervals and receive serologic response assessment following completion of the HEPLISAV-B vaccine series (6 months after the first vaccine

administration).

Study Objectives:
Primary Objective:
  1. Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs greater than or equal to 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) in the following populations:
  • CLL patients who are treatment naive (n=54)

  • CLL patients receiving treatment with ibrutinib (n=27)

  • CLL patients receiving treatment with acalabrutinib (n=27)

Secondary Objective:
  1. Determine the safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Response to the HEPLISAV-B Hepatitis B Vaccine in Treatment Naive Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's -Tyrosine Kinase Inhibitor (BTK-I)
Actual Study Start Date :
Dec 7, 2018
Actual Primary Completion Date :
Dec 16, 2020
Actual Study Completion Date :
Dec 16, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

Biological: HEPLISAV-B
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.

Experimental: 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.

Biological: HEPLISAV-B
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.

Experimental: 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.

Biological: HEPLISAV-B
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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With HEPLISAV-B Seroprotective Titer (Anti-HBs 10mIU/mL) [6 months after the first vaccine administration]

    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).

Secondary Outcome Measures

  1. Number of Participants That Experienced Serious Adverse Events Following HEPLISAV-B Vaccine Among CLL Patients [6 months after the first vaccine administration]

    Determine 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).

  2. Number of Participants That Did Not Complete Study Due to Intolerance of the HEPLISAV-B Vaccine Among CLL Patients. [6 months after the first vaccine administration]

    Determine 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • INCLUSION CRITERIA:

  • Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group.

  • No known active or past hepatitis B infection

  • No history of prior hepatitis B virus vaccination (approved or investigational)

  • History of negative hepatitis B viral titers (negative HBsAg, HBsAb and HBcAb)

  • Cohort 1: Treatment naive CLL patients

  • Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose

  • Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose

  • Age greater than or equal to 18 years.

  • ECOG performance status of 0-1

  • Able to comprehend the investigational nature of the protocol and provide informed consent.

EXCLUSION CRITERIA:
  • Female patients who are currently pregnant.

  • Any uncontrolled active systemic infection

  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk

  • History of severe allergic reaction to any component of HEPLISAV-B, including yeast

  • Receive intravenous or subcutaneous immunoglobulin (IVIG) within 3 months prior to vaccination

  • Concomitant use of immunosuppressive agents (e.g. steroids, radiotherapy, chemotherapy)

  • Hereditary or acquired immunodeficiency syndrome unrelated to CLL

  • Non-English speaking individuals will be excluded from the study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

Sponsors and Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Christopher MT Pleyer, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT03685708
Other Study ID Numbers:
  • 180145
  • 18-H-0145
First Posted:
Sep 26, 2018
Last Update Posted:
Feb 8, 2022
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsA total of 78 participants were assessed for eligibility and consented. 76 participants met eligibility criteria.
Pre-assignment Detail
Arm/Group TitleChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Arm/Group DescriptionAcalabrutinib 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.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.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.
Period Title: Overall Study
STARTED141846
COMPLETED131637
NOT COMPLETED129

Baseline Characteristics

Arm/Group TitleChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment NaïveTotal
Arm/Group DescriptionAcalabrutinib 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.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.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 of all reporting groups
Overall Participants14184678
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
9
64.3%
6
33.3%
22
47.8%
37
47.4%
>=65 years
5
35.7%
12
66.7%
24
52.2%
41
52.6%
Sex: Female, Male (Count of Participants)
Female
3
21.4%
6
33.3%
20
43.5%
29
37.2%
Male
11
78.6%
12
66.7%
26
56.5%
49
62.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
1
5.6%
2
4.3%
3
3.8%
Not Hispanic or Latino
14
100%
17
94.4%
43
93.5%
74
94.9%
Unknown or Not Reported
0
0%
0
0%
1
2.2%
1
1.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
1
2.2%
1
1.3%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
1
7.1%
0
0%
2
4.3%
3
3.8%
White
12
85.7%
17
94.4%
42
91.3%
71
91%
More than one race
1
7.1%
1
5.6%
1
2.2%
3
3.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants With HEPLISAV-B Seroprotective Titer (Anti-HBs 10mIU/mL)
DescriptionDetermine 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).
Time Frame6 months after the first vaccine administration

Outcome Measure Data

Analysis Population Description
All participants that completed the 2 doses vaccine series and blood draws. 8 participants could not complete laboratory assessments due to COVID pandemic.
Arm/Group TitleChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Arm/Group DescriptionAcalabrutinib 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.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.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.
Measure Participants111532
Count of Participants [Participants]
0
0%
1
5.6%
9
19.6%
2. Secondary Outcome
TitleNumber of Participants That Experienced Serious Adverse Events Following HEPLISAV-B Vaccine Among CLL Patients
DescriptionDetermine 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).
Time Frame6 months after the first vaccine administration

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Arm/Group DescriptionAcalabrutinib 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.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.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.
Measure Participants141846
Count of Participants [Participants]
0
0%
0
0%
1
2.2%
3. Secondary Outcome
TitleNumber of Participants That Did Not Complete Study Due to Intolerance of the HEPLISAV-B Vaccine Among CLL Patients.
DescriptionDetermine 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).
Time Frame6 months after the first vaccine administration

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Arm/Group DescriptionAcalabrutinib 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.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.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.
Measure Participants141846
Count of Participants [Participants]
0
0%
0
0%
0
0%

Adverse Events

Time FrameEvents will be collected for 7 days following the first and second vaccine dose and followed until resolution
Adverse Event Reporting Description 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.
Arm/Group TitleChronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Arm/Group DescriptionAcalabrutinib 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.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.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.
All Cause Mortality
Chronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/14 (0%) 0/18 (0%) 0/46 (0%)
Serious Adverse Events
Chronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/14 (0%) 0/18 (0%) 1/46 (2.2%)
Infections and infestations
Lung infection0/14 (0%) 00/18 (0%) 01/46 (2.2%) 1
Other (Not Including Serious) Adverse Events
Chronic Lymphocytic Leukemia Patients Receiving Treatment With AcalabrutinibChronic Lymphocytic Leukemia Patients Receiving Treatment With IbrutinibChronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total12/14 (85.7%) 17/18 (94.4%) 40/46 (87%)
Blood and lymphatic system disorders
Lymph node pain0/14 (0%) 01/18 (5.6%) 10/46 (0%) 0
Gastrointestinal disorders
Dyspepsia1/14 (7.1%) 10/18 (0%) 00/46 (0%) 0
Mucositis oral1/14 (7.1%) 10/18 (0%) 00/46 (0%) 0
Nausea0/14 (0%) 02/18 (11.1%) 20/46 (0%) 0
Nausea0/14 (0%) 00/18 (0%) 07/46 (15.2%) 7
General disorders
Chills2/14 (14.3%) 21/18 (5.6%) 19/46 (19.6%) 12
Edema limbs3/14 (21.4%) 32/18 (11.1%) 410/46 (21.7%) 11
Fatigue5/14 (35.7%) 118/18 (44.4%) 1320/46 (43.5%) 36
Flu like symptoms2/14 (14.3%) 40/18 (0%) 011/46 (23.9%) 19
Injection site reaction2/14 (14.3%) 27/18 (38.9%) 98/46 (17.4%) 13
Pain12/14 (85.7%) 3216/18 (88.9%) 3235/46 (76.1%) 98
Vaccination site lymphadenopathy0/14 (0%) 02/18 (11.1%) 20/46 (0%) 0
Fever0/14 (0%) 00/18 (0%) 04/46 (8.7%) 5
Vaccination site lymphadenopathy0/14 (0%) 00/18 (0%) 04/46 (8.7%) 6
Infections and infestations
Conjunctivitis0/14 (0%) 01/18 (5.6%) 10/46 (0%) 0
Injury, poisoning and procedural complications
Bruising1/14 (7.1%) 33/18 (16.7%) 30/46 (0%) 0
Bruising0/14 (0%) 00/18 (0%) 03/46 (6.5%) 3
Musculoskeletal and connective tissue disorders
Muscle cramp1/14 (7.1%) 10/18 (0%) 00/46 (0%) 0
Myalgia6/14 (42.9%) 105/18 (27.8%) 919/46 (41.3%) 30
Neck pain0/14 (0%) 01/18 (5.6%) 10/46 (0%) 0
Nervous system disorders
Syncope1/14 (7.1%) 10/18 (0%) 00/46 (0%) 0
Dizziness0/14 (0%) 01/18 (5.6%) 10/46 (0%) 0
Headache2/14 (14.3%) 27/18 (38.9%) 82/46 (4.3%) 2
Neuralgia0/14 (0%) 01/18 (5.6%) 10/46 (0%) 0
Dizziness0/14 (0%) 00/18 (0%) 03/46 (6.5%) 3
Headache0/14 (0%) 00/18 (0%) 022/46 (47.8%) 35
Respiratory, thoracic and mediastinal disorders
Sore throat1/14 (7.1%) 10/18 (0%) 00/46 (0%) 0
Skin and subcutaneous tissue disorders
Hyperhidrosis0/14 (0%) 01/18 (5.6%) 10/46 (0%) 0
Rash maculo-papular3/14 (21.4%) 68/18 (44.4%) 1220/46 (43.5%) 26
Pruritus0/14 (0%) 00/18 (0%) 05/46 (10.9%) 6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleChristopher Pleyer, M.D. Principal Investigator, NIH, NHLBI
OrganizationNational Institutes of Health (NIH) / The National Heart, Lung, and Blood Institute (NHLBI)
Phone510.709.6649
Emailchristopher.pleyer@nih.gov
Responsible Party:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT03685708
Other Study ID Numbers:
  • 180145
  • 18-H-0145
First Posted:
Sep 26, 2018
Last Update Posted:
Feb 8, 2022
Last Verified:
Jun 1, 2021