Cytomegalovirus InfectionsPhase 1NCT03576014
Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient
A Phase 1 study testing BD03 in people with Cytomegalovirus Infections and Preventation of Cytomegalovirus Reactivation, run by SL VAXiGEN at 2 sites in South Korea.
Trial summary
This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients. The recommended dose will be selected based on the safety and tolerability profiles observed. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cytomegalovirus Infections, Preventation of Cytomegalovirus Reactivation, BK Virus Infection
- What is being tested?
- BD03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Apr 2018to 24 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of ≥ 19
- Body Mass Index ≤ 35
- Weight ≥ 40kg
Who cannot join
- CMV IgG seronegative patient
- Patient scheduled for retransplant of kidney
- Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- Patient expected to receive T-cell depleting agents or rituximab
- Patient with history of splenectomy
- Patient with CMV related disease or shows active CMV infection or who has been treated with CMV related disease or CMV infection within 3 months from consent date.
Show all 17Show fewer
- Patient expected to undergo CMV prophylaxis using anti-virals or immunoglobulins.
- Patient who has hypersensitivity to BD03 or components of BD03.
- Patient with history of epilepsy or seizure with the last 2 years
- Patients with pre-excitation syndrome or any other disease who would be considered ineligible for electroporation injection.
- Patient with blood coagulation disorder who would be considered ineligible for electroporation injection
- Patient with injection site thickness greater than 40mm
- Patient with artificial implant near injection site
- Pregnant or breast-feeding female patient
- Female subject or partner of male subject with child bearing potential and who has not agreed to sexual abstinence
- Patient who has participated in any other clinical trial within 30 days
- Patient who has any clinically meaningful disease investigator's judgement to prevent participating in this study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical center
Seoul, 06351
Sungjoo Kim, M.D, Ph.D
- Recruiting
Seoul St.Mary's Hospital
Seoul, 06591
Chulwoo Yang, M.D, Ph.D
About this study
Official title: A Prospective, Open, Dose-escalation, Multi-center, Phase 1 Trial to Evaluate Tolerability and Safety of Intramuscularly Administered BD03, a DNA Vaccine for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient
This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients. The recommended dose will be selected based on the safety and tolerability profiles observed.
Read the detailed description
It is reported that CMV and BKV infection and/or reactivations are associated with mortality and morbidity of kidney transplant recipient, and occurrence of PyVAN in kidney transplant recipients.
BD03 is a DNA vaccine that consists of 3 plasmid DNAs encoding CMV antigens, BKV antigens and genetic adjuvant. It is expected to express antigen specific T-cell immune response, and ultimately prevent activation of both viruses. Plasmid DNA that encode CMV and BKV antigens are fused with tPA and Flt-3L to promote antigen specific immune response.
Patient scheduled to receive kidney transplant from living donor are enrolled in this study. Eligible subjects will receive BD03 intramuscularly by electroporator three times on 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant.
This study will be comprised of 3+3 dose escalation scheme and starting dose is 0.6mg and dose will be increased to 2mg and 6mg.
Occurrence of dose limiting toxicities observed until 1 week after second injection (1week before kidney transplant) will guide whether to increase a dose.
After third injection of BD03, follow up visits are done for 18 weeks.
- Conditions
- Cytomegalovirus Infections, Preventation of Cytomegalovirus Reactivation, BK Virus Infection, Preventation of BK Virus Reactivation
- Being tested
- BD03
- Keywords
- CMV, BKV, CMV Reactivation, BKV Reactivation, DNA Vaccine, Kidney transplant, Cytomegalovirus, BK virus
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD03Biological
BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant.
| Study group | Role | What they receive |
|---|---|---|
| BD03 | Experimental | This study will be comprised of 3+3 dose escalation design with three dose levels, 0.6mg (cohort1), 2mg(cohort2), 6mg(cohort3).
Decision to increase dose will be guided by occurrence of DLT (dose limiting toxicity) evaluated 1week after the second injection (5weeks after first injection) Receives: Biological: BD03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability as measured by dose-limiting toxicities (DLTs)
An event will be considered a DLT if the event is reasonably related to study treatment during the 5weeks of treatment, and meets the following criteria: Any Grade 3 or greater toxicity per CTCAE 4.03 that would be considered dose-limiting except for those associated with kidney failure, Grade 3 or greater Creatine kinase increase that is not accompanied with Rhabdomyolysis, and any other Grade3 or greater toxicity that exists before participation of this study.
Measured: 5 weeks
Secondary outcomes (4)
Proportion of subjects whose Spot Forming Units per unit PBMC are tripled compared to base line measurements and subjects whose Spot Forming Units of each antigen in 10^6 PBMC are greater than 50.
To evaluate the immunogenicity of BD03. ELISPOT assay of specific T cell responses to CMV and BKV antigens.
Measured: Up to 30 weeks post-dose
Antibody response to CMV gB antigen
To investigate antibody level measured by Enzyme-Linked ImmunoSorbent Assay(ELISA)
Measured: Up to 30 weeks post-dose
Antibody response to BKV VP1 antigen
To investigate antibody level measured by Enzyme-Linked ImmunoSorbent Assay(ELISA)
Measured: Up to 30 weeks post-dose
Change of CMV and BKV plasma viral load over time
To investigate change of CMV and BKV plasma viral load over time
Measured: Up to 30 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start27 Apr 2018
- Primary completion30 Jan 2019 (estimated)
- Study completion24 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SL VAXiGEN
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SL BIGEN
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576014
- Sponsor's protocol ID
- BD03_KT_P1
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hirsch HH, Randhawa P; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation. Am J Transplant. 2013 Mar;13 Suppl 4:179-88. doi: 10.1111/ajt.12110.
PubMed 23465010Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
PubMed 19845597
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Dose-escalation, Multi-center, Phase 1 Trial to Evaluate Tolerability and Safety of Intramuscularly Administered BD03, a DNA Vaccine for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient
- ClinicalTrials.gov ID
- NCT03576014
- Acronym / sponsor ID
- BD03_KT_P1
- Conditions
- Cytomegalovirus Infections, Preventation of Cytomegalovirus Reactivation, BK Virus Infection, Preventation of BK Virus Reactivation
- Keywords
- CMV, BKV, CMV Reactivation, BKV Reactivation, DNA Vaccine, Kidney transplant, Cytomegalovirus, BK virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- SL VAXiGENIndustry (pharma, biotech, devices)
- Collaborators
- SL BIGEN
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 24 Jul 2019 (estimated)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients. The recommended dose will be selected based on the safety and tolerability profiles observed.
Detailed description
It is reported that CMV and BKV infection and/or reactivations are associated with mortality and morbidity of kidney transplant recipient, and occurrence of PyVAN in kidney transplant recipients.
BD03 is a DNA vaccine that consists of 3 plasmid DNAs encoding CMV antigens, BKV antigens and genetic adjuvant. It is expected to express antigen specific T-cell immune response, and ultimately prevent activation of both viruses. Plasmid DNA that encode CMV and BKV antigens are fused with tPA and Flt-3L to promote antigen specific immune response.
Patient scheduled to receive kidney transplant from living donor are enrolled in this study. Eligible subjects will receive BD03 intramuscularly by electroporator three times on 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant.
This study will be comprised of 3+3 dose escalation scheme and starting dose is 0.6mg and dose will be increased to 2mg and 6mg.
Occurrence of dose limiting toxicities observed until 1 week after second injection (1week before kidney transplant) will guide whether to increase a dose.
After third injection of BD03, follow up visits are done for 18 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD03 | Experimental | Biological: BD03This study will be comprised of 3+3 dose escalation design with three dose levels, 0.6mg (cohort1), 2mg(cohort2), 6mg(cohort3). Decision to increase dose will be guided by occurrence of DLT (dose limiting toxicity) evaluated 1week after the second injection (5weeks after first injection) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of ≥ 19
- Body Mass Index ≤ 35
- Weight ≥ 40kg
Key exclusion criteria (17 listed)
- CMV IgG seronegative patient
- Patient scheduled for retransplant of kidney
- Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- Patient expected to receive T-cell depleting agents or rituximab
- Patient with history of splenectomy
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 |
|---|---|---|
| BD03BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant. | Biological | BD03 |
Primary outcome
Tolerability as measured by dose-limiting toxicities (DLTs)
Time frame: 5 weeks
An event will be considered a DLT if the event is reasonably related to study treatment during the 5weeks of treatment, and meets the following criteria: Any Grade 3 or greater toxicity per CTCAE 4.03 that would be considered dose-limiting except for those associated with kidney failure, Grade 3 or greater Creatine kinase increase that is not accompanied with Rhabdomyolysis, and any other Grade3 or greater toxicity that exists before participation of this study.
4 secondary outcomes
Proportion of subjects whose Spot Forming Units per unit PBMC are tripled compared to base line measurements and subjects whose Spot Forming Units of each antigen in 10^6 PBMC are greater than 50.
Time frame: Up to 30 weeks post-dose
Antibody response to CMV gB antigen
Time frame: Up to 30 weeks post-dose
Antibody response to BKV VP1 antigen
Time frame: Up to 30 weeks post-dose
Change of CMV and BKV plasma viral load over time
Time frame: Up to 30 weeks post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 23465010Hirsch HH, Randhawa P; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation. Am J Transplant. 2013 Mar;13 Suppl 4:179-88. doi: 10.1111/ajt.12110.
- Background: PubMed 19845597Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BD03 in people with Cytomegalovirus Infections and Preventation of Cytomegalovirus Reactivation, run by SL VAXiGEN at 2 sites in South Korea.
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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujin Kim, Ph.D (031-628-2182, sjkim@slvaxigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability as measured by dose-limiting toxicities (DLTs) (time frame: 5 weeks). 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 NCT03576014, 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 3 Jul 2018.