Safety and TolerabilityPhase 2NCT03702231
Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
A Phase 2 study testing Zoster Vaccine Recombinant, Adjuvanted in people with Safety and Tolerability and Compare SHINGRIX Vaccine Response Rates, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates, Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- Zoster Vaccine Recombinant, Adjuvanted
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 12 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group
- Cohort 1:Treatment naive CLL/SLL patients
- Cohort 2: Subjects must be receiving treatment ibrutinib for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to administration of the first vaccine dose
- No active, symptomatic VZV or herpes zoster infection within 12 months prior to vaccination
- No exposure to the live VZV vaccine (ZOSTAVAX) within 12 months prior to vaccination
Show all 10Show fewer
- No prior exposure to the SHINGRIX vaccine
- Age greater than or equal to 18 years.
- ECOG performance status of 0-2
- Able to comprehend the investigational nature of the protocol and provide informed consent
Who cannot join
- Female patients who are currently in pregnancy
- 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
- Severe allergic reaction to any component of SHINGRIX.
- Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.
- Concomitant use of immunosuppressive agents (e.g. steroids, radio
Show all 9Show fewer
- therapy, chemotherapy)
- Hereditary or acquired immunodeficiency syndrome unrelated to chronic lymphocytic leukemia
- Non-English speaking individuals will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy
Background:
People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL.
Read more
Objective:
To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL).
Eligibility:
Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments.
Design:
Participants will be screened with a chart review or through another protocol.
Visit 1
At visit 1, participants may have a pregnancy test, blood test, or physical exam.
Pregnant participants cannot be in the study.
Eligible participants will get the shingles vaccine as an injection.
Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.
Visit 2
Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine.
Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.
Visit 3
Visit 3 will be 3 months after visit 2. Participants will have blood taken.
Participants may be able to get an additional vaccine the same day as the shingles vaccine.
Read the detailed description
This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I). (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:
- Diagnosis of CLL or SLL
- Cohort 1: Treatment naive CLL or SLL patients
- Cohort 2: Subjects must be receiving ibrutinib for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib 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
Design:
Patients with CLL will enroll on the study for the purpose of determining the SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given at 0- and 3- month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6 months after the first vaccine dose administration.
Study Objectives:
Primary Objective:
a)Determine the serologic response against VZV after completing the SHINGRIX (RZV) 2-
dose vaccine series in the following populations:
- CLL patients that are treatment naive (n=54)
- CLL patients receiving treatment with ibrutinib (n=27)
- CLL patients receiving treatment with acalabrutinib (n=27)
Secondary Objective:
- Determine the safety and tolerability of the SHINGRIX vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).
- Conditions
- Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- Being tested
- Zoster Vaccine Recombinant, Adjuvanted
- Keywords
- Ibrutinib, Acalabrutinib, Shingles, Herpes
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Herpes Zoster, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoster Vaccine Recombinant, AdjuvantedBiological
Also called SHINGRIX
A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia Patients That Are Treatment Naive | Experimental | Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Receives: Biological: Zoster Vaccine Recombinant, Adjuvanted |
| Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib | Experimental | Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Receives: Biological: Zoster Vaccine Recombinant, Adjuvanted |
| Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib | Experimental | Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. Receives: Biological: Zoster Vaccine Recombinant, Adjuvanted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
Measured: 6 months after the first vaccine administration
Secondary outcomes (2)
Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
Determine the safety and tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
Measured: 6 months after the first vaccine administration
Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
Determine the tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
Measured: 6 months after the first vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start7 Dec 2018
- Primary completion9 Sep 2020
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety and TolerabilityStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christopher MT Pleyer, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702231
- Sponsor's protocol ID
- 190001
- Other IDs
- 19-H-0001
- Status last verified
- Feb 2023
- First submitted
- 10 Oct 2018
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pleyer C, Laing KJ, Ali MA, McClurkan CL, Soto S, Ahn IE, Nierman P, Maddux E, Lotter J, Superata J, Tian X, Wiestner A, Cohen JI, Koelle DM, Sun C. BTK inhibitors impair humoral and cellular responses to recombinant zoster vaccine in CLL. Blood Adv. 2022 Mar 22;6(6):1732-1740. doi: 10.1182/bloodadvances.2021006574.
PubMed 35157769Pleyer C, Ali MA, Cohen JI, Tian X, Soto S, Ahn IE, Gaglione EM, Nierman P, Marti GE, Hesdorffer C, Lotter J, Superata J, Wiestner A, Sun C. Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines. Blood. 2021 Jan 14;137(2):185-189. doi: 10.1182/blood.2020008758.
PubMed 33259596
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy
- ClinicalTrials.gov ID
- NCT03702231
- Acronym / sponsor ID
- 190001
- Conditions
- Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- Keywords
- Ibrutinib, Acalabrutinib, Shingles, Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL.
Objective:
To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL).
Eligibility:
Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments.
Design:
Participants will be screened with a chart review or through another protocol.
Visit 1
At visit 1, participants may have a pregnancy test, blood test, or physical exam.
Pregnant participants cannot be in the study.
Eligible participants will get the shingles vaccine as an injection.
Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.
Visit 2
Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine.
Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.
Visit 3
Visit 3 will be 3 months after visit 2. Participants will have blood taken.
Participants may be able to get an additional vaccine the same day as the shingles vaccine.
Detailed description
This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I). (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:
- Diagnosis of CLL or SLL
- Cohort 1: Treatment naive CLL or SLL patients
- Cohort 2: Subjects must be receiving ibrutinib for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib 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
Design:
Patients with CLL will enroll on the study for the purpose of determining the SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given at 0- and 3- month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6 months after the first vaccine dose administration.
Study Objectives:
Primary Objective:
a)Determine the serologic response against VZV after completing the SHINGRIX (RZV) 2-
dose vaccine series in the following populations:
- CLL patients that are treatment naive (n=54)
- CLL patients receiving treatment with ibrutinib (n=27)
- CLL patients receiving treatment with acalabrutinib (n=27)
Secondary Objective:
- Determine the safety and tolerability of the SHINGRIX vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia Patients That Are Treatment Naive | Experimental | Biological: Zoster Vaccine Recombinant, AdjuvantedChronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. |
| Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib | Experimental | Biological: Zoster Vaccine Recombinant, AdjuvantedChronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. |
| Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib | Experimental | Biological: Zoster Vaccine Recombinant, AdjuvantedChronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group
- Cohort 1:Treatment naive CLL/SLL patients
- Cohort 2: Subjects must be receiving treatment ibrutinib for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to administration of the first vaccine dose
- No active, symptomatic VZV or herpes zoster infection within 12 months prior to vaccination
Key exclusion criteria (9 listed)
- Female patients who are currently in pregnancy
- 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
- Severe allergic reaction to any component of SHINGRIX.
- Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoster Vaccine Recombinant, AdjuvantedAlso: SHINGRIXA series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection. | Biological | Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib, Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib, Chronic Lymphocytic Leukemia Patients That Are Treatment Naive |
Primary outcome
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
Time frame: 6 months after the first vaccine administration
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
2 secondary outcomes
Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
Time frame: 6 months after the first vaccine administration
Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
Time frame: 6 months after the first vaccine administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35157769Pleyer C, Laing KJ, Ali MA, McClurkan CL, Soto S, Ahn IE, Nierman P, Maddux E, Lotter J, Superata J, Tian X, Wiestner A, Cohen JI, Koelle DM, Sun C. BTK inhibitors impair humoral and cellular responses to recombinant zoster vaccine in CLL. Blood Adv. 2022 Mar 22;6(6):1732-1740. doi: 10.1182/bloodadvances.2021006574.
- Derived from this study: PubMed 33259596Pleyer C, Ali MA, Cohen JI, Tian X, Soto S, Ahn IE, Gaglione EM, Nierman P, Marti GE, Hesdorffer C, Lotter J, Superata J, Wiestner A, Sun C. Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines. Blood. 2021 Jan 14;137(2):185-189. doi: 10.1182/blood.2020008758.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Safety and Tolerability
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher MT Pleyer, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoster Vaccine Recombinant, Adjuvanted in people with Safety and Tolerability and Compare SHINGRIX Vaccine Response Rates, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer (time frame: 6 months after the first vaccine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.