A Study to Evaluate Safety & Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19
NCT ID: NCT05102643
Last Updated: 2022-01-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-18
Study Completion Date
2022-12-31
Brief Summary
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To investigate the safety and immunogenicity profile of of a novel and investigational SARS-CoV-2 DNA vaccine, which is delivered intramuscularly followed by electroporation to enhance vaccine penetration, as a potential prophylactic vaccine for current pandemic disease COVID-19.
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Detailed Description
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This is a first-in-human, randomized, double-blinded, placebo-controlled study which comprises two cohorts. Each subject will receive 2 vaccinations 3 weeks apart at one of the 2 dose levels or matching placebo. Each subject will only participate in one cohort. The approximate duration for each subject's participation in the study (from screening to Day 50(±3) visit) is 2.5 months.
Conditions
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Covid19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Subjects will be enrolled into 2 cohorts and each subject will receive 2 vaccinations at one of the 2 dose levels or matching placebo. Each subject will only participate in one cohort. A Safety Review Committee (SRC) will be set up to review safety data and make decision on dose escalation.
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Test Product
SARS-CoV-2 DNA Vaccine at 1mg and 2mg, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
Group Type
EXPERIMENTAL
SARS-CoV-2 DNA Vaccine
Intervention Type
BIOLOGICAL
A novel vaccine developed for prophylaxis of COVID-19 based on HKU's PD-1-based DNA vaccine platform. It encodes a recombinant antigen comprising a soluble human PD-1 domain (i.e. programmed cell death protein, a member of the Cluster of Differentiation 28 (CD28) family) and the receptor binding domain (RBD) of SARS-CoV-2 (i.e. the key viral entry element).
Reference Product
Matching placebo, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
Group Type
PLACEBO_COMPARATOR
Matching placebo
Intervention Type
BIOLOGICAL
Solution for intramuscular injection
Interventions
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SARS-CoV-2 DNA Vaccine
A novel vaccine developed for prophylaxis of COVID-19 based on HKU's PD-1-based DNA vaccine platform. It encodes a recombinant antigen comprising a soluble human PD-1 domain (i.e. programmed cell death protein, a member of the Cluster of Differentiation 28 (CD28) family) and the receptor binding domain (RBD) of SARS-CoV-2 (i.e. the key viral entry element).
Intervention Type
BIOLOGICAL
Matching placebo
Solution for intramuscular injection
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1. Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
2. Gender and Age: Male or female, at the age of ≥ 18 and ≤ 55 on the day of signing the ICF.
3. Body Weight and BMI: Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and \< 25 kg/m2 at screening and baseline.
4. Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
1. Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
2. Normal vital signs at screening and baseline, as defined by:
* Body (tympanic) temperature ≤ 37.5oC;
* Resting pulse rate ≥ 50 and ≤ 100 bpm; and
* DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
5. Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
1. A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the first vaccination until 60 days after the second vaccination;
2. A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the first vaccination until 60 days after the second vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
6. Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the first vaccination until 60 days after the second vaccination.
7. Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.
2. Gender and Age: Male or female, at the age of ≥ 18 and ≤ 55 on the day of signing the ICF.
3. Body Weight and BMI: Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and \< 25 kg/m2 at screening and baseline.
4. Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
1. Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
2. Normal vital signs at screening and baseline, as defined by:
* Body (tympanic) temperature ≤ 37.5oC;
* Resting pulse rate ≥ 50 and ≤ 100 bpm; and
* DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
5. Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
1. A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the first vaccination until 60 days after the second vaccination;
2. A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the first vaccination until 60 days after the second vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
6. Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the first vaccination until 60 days after the second vaccination.
7. Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.
Exclusion Criteria
1. Medical History: History of any of the following diseases or conditions:
1. COVID-19;
2. SARS;
3. Any significant respiratory diseases (e.g. COPD, asthma);
4. Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
5. Blood dyscrasias or any significant disorder of coagulation;
6. Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
7. Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
8. Any malignant neoplastic disease;
9. Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
10. Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
11. Any immunodeficiency or autoimmune disease;
12. Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
13. History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.
2. Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
1. Positive serum pregnancy test at screening or positive urine pregnancy test at baseline (for WOCBP);
2. IgE level \> 1,000 IU/ml at screening;
3. Positive SARS-CoV-2 test result in serum or deep throat saliva (DTS) within 4 days prior to baseline;
4. T3, T4 or TSH \< LLN or \> ULN at screening;
5. Positive HIV test result at screening;
6. Positive HBsAg test result at screening;
7. Positive HCV antibody test result at screening;
8. Positive urine drug screen test result or positive blood alcohol test result at screening or baseline;
9. Any clinically significant findings (e.g. active or acute cardiac/pulmonary diseases) from chest X-ray examination performed at or within 4 months prior to screening.
3. Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
1. Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination, or planned use of any such vaccine throughout the study;
2. Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to the first vaccination, or planned use of any such vaccine up to 28 days after the second vaccination;
3. Any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to the first vaccination, or planned use of any such medication/therapy throughout the study;
4. Any blood product (including blood transfusion) or immunoglobulin within 3 months prior to the first vaccination, or planned use of any such therapy throughout the study;
5. Any anticoagulation medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
6. Any psychotropic medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
7. Regular use of any topical corticosteroids at or near the intended administration site (upper arm);
8. Any influenza antiviral medication within 48 hours prior to the first vaccination, or planned use of any such medication up to 14 days after the second vaccination;
9. Any prescription or over-the-counter medication or supplement product (e.g. vitamin, dietary supplement, herbal preparation) within 7 days prior to the first vaccination, unless with the investigator's approval for managing a chronic condition;
10. Donated ≥ 450 ml of blood within 28 days prior to the first vaccination.
4. Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
1. Prior or current participation in another COVID-19 vaccine study;
2. Prior participation in any interventional clinical study and use of any investigational intervention within 90 days prior to the first vaccination;
3. Concurrent participation or plan for participation in another interventional clinical study during participation in this study.
5. Other Significant Medical Conditions: Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study.
6. Special Conditions: Existence of any of the following special conditions:
1. Close contact with anyone known to have COVID-19 within 30 days prior to the first vaccination;
2. Travelled outside Hong Kong within 14 days prior to the first vaccination;
3. Planned to travel outside Hong Kong at any time during the period from screening to Day 50(±3) visit.
1. COVID-19;
2. SARS;
3. Any significant respiratory diseases (e.g. COPD, asthma);
4. Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
5. Blood dyscrasias or any significant disorder of coagulation;
6. Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
7. Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
8. Any malignant neoplastic disease;
9. Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
10. Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
11. Any immunodeficiency or autoimmune disease;
12. Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
13. History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.
2. Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
1. Positive serum pregnancy test at screening or positive urine pregnancy test at baseline (for WOCBP);
2. IgE level \> 1,000 IU/ml at screening;
3. Positive SARS-CoV-2 test result in serum or deep throat saliva (DTS) within 4 days prior to baseline;
4. T3, T4 or TSH \< LLN or \> ULN at screening;
5. Positive HIV test result at screening;
6. Positive HBsAg test result at screening;
7. Positive HCV antibody test result at screening;
8. Positive urine drug screen test result or positive blood alcohol test result at screening or baseline;
9. Any clinically significant findings (e.g. active or acute cardiac/pulmonary diseases) from chest X-ray examination performed at or within 4 months prior to screening.
3. Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
1. Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination, or planned use of any such vaccine throughout the study;
2. Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to the first vaccination, or planned use of any such vaccine up to 28 days after the second vaccination;
3. Any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to the first vaccination, or planned use of any such medication/therapy throughout the study;
4. Any blood product (including blood transfusion) or immunoglobulin within 3 months prior to the first vaccination, or planned use of any such therapy throughout the study;
5. Any anticoagulation medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
6. Any psychotropic medication within 28 days prior to the first vaccination, or planned use of any such medication up to 28 days after the second vaccination;
7. Regular use of any topical corticosteroids at or near the intended administration site (upper arm);
8. Any influenza antiviral medication within 48 hours prior to the first vaccination, or planned use of any such medication up to 14 days after the second vaccination;
9. Any prescription or over-the-counter medication or supplement product (e.g. vitamin, dietary supplement, herbal preparation) within 7 days prior to the first vaccination, unless with the investigator's approval for managing a chronic condition;
10. Donated ≥ 450 ml of blood within 28 days prior to the first vaccination.
4. Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
1. Prior or current participation in another COVID-19 vaccine study;
2. Prior participation in any interventional clinical study and use of any investigational intervention within 90 days prior to the first vaccination;
3. Concurrent participation or plan for participation in another interventional clinical study during participation in this study.
5. Other Significant Medical Conditions: Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study.
6. Special Conditions: Existence of any of the following special conditions:
1. Close contact with anyone known to have COVID-19 within 30 days prior to the first vaccination;
2. Travelled outside Hong Kong within 14 days prior to the first vaccination;
3. Planned to travel outside Hong Kong at any time during the period from screening to Day 50(±3) visit.
Minimum Eligible Age
18 Years
Maximum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Immuno Cure 3 Limited
INDUSTRY
Sponsor Role
collaborator
The University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ivan Fan-ngai Hung
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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HKU Phase 1 Clinical Trials Centre
Hong Kong, , Hong Kong
Site Status
RECRUITING
Countries
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Hong Kong
Central Contacts
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References
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SARS-CoV-2 DNA Vaccine - Investigator's Brochure (Version 1.0, Dated 24-Sep-2021).
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BACKGROUND
Alter G, Yu J, Liu J, Chandrashekar A, Borducchi EN, Tostanoski LH, McMahan K, Jacob-Dolan C, Martinez DR, Chang A, Anioke T, Lifton M, Nkolola J, Stephenson KE, Atyeo C, Shin S, Fields P, Kaplan I, Robins H, Amanat F, Krammer F, Baric RS, Le Gars M, Sadoff J, de Groot AM, Heerwegh D, Struyf F, Douoguih M, van Hoof J, Schuitemaker H, Barouch DH. Immunogenicity of Ad26.COV2.S vaccine against SARS-CoV-2 variants in humans. Nature. 2021 Aug;596(7871):268-272. doi: 10.1038/s41586-021-03681-2. Epub 2021 Jun 9.
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Gallagher, K., Leick, M. B., Larson, R. C., Berger, T. R., Katsis, K., Yam, J. Y., Brini, G., Grauwet, K., MGH COVID-19 Collection & Processing Team, & Maus, M. V. (2021) 'SARS -CoV-2 T-cell immunity to variants of concern following vaccination', bioRxiv 2021.05.03.442455, Advance online publication. doi:10.1101/2021.05.03.442455.
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Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, Bailer RT, Chakrabarti BK, Bailey MA, Gomez PL, Andrews CA, Moodie Z, Gu L, Stein JA, Nabel GJ, Graham BS. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol. 2006 Nov;13(11):1267-77. doi: 10.1128/CVI.00162-06. Epub 2006 Sep 20.
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Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24.
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Tan Z, Zhou J, Cheung AK, Yu Z, Cheung KW, Liang J, Wang H, Lee BK, Man K, Liu L, Yuen KY, Chen Z. Vaccine-elicited CD8+ T cells cure mesothelioma by overcoming tumor-induced immunosuppressive environment. Cancer Res. 2014 Nov 1;74(21):6010-21. doi: 10.1158/0008-5472.CAN-14-0473. Epub 2014 Aug 14.
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Tebas P, Yang S, Boyer JD, Reuschel EL, Patel A, Christensen-Quick A, Andrade VM, Morrow MP, Kraynyak K, Agnes J, Purwar M, Sylvester A, Pawlicki J, Gillespie E, Maricic I, Zaidi FI, Kim KY, Dia Y, Frase D, Pezzoli P, Schultheis K, Smith TRF, Ramos SJ, McMullan T, Buttigieg K, Carroll MW, Ervin J, Diehl MC, Blackwood E, Mammen MP, Lee J, Dallas MJ, Brown AS, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. EClinicalMedicine. 2021 Jan;31:100689. doi: 10.1016/j.eclinm.2020.100689. Epub 2020 Dec 24.
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Wong YC, Liu W, Yim LY, Li X, Wang H, Yue M, Niu M, Cheng L, Ling L, Du Y, Chen SMY, Cheung KW, Wang H, Tang X, Tang J, Zhang H, Song Y, Chakrabarti LA, Chen Z. Sustained viremia suppression by SHIVSF162P3CN-recalled effector-memory CD8+ T cells after PD1-based vaccination. PLoS Pathog. 2021 Jun 14;17(6):e1009647. doi: 10.1371/journal.ppat.1009647. eCollection 2021 Jun.
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Vasan S, Hurley A, Schlesinger SJ, Hannaman D, Gardiner DF, Dugin DP, Boente-Carrera M, Vittorino R, Caskey M, Andersen J, Huang Y, Cox JH, Tarragona-Fiol T, Gill DK, Cheeseman H, Clark L, Dally L, Smith C, Schmidt C, Park HH, Kopycinski JT, Gilmour J, Fast P, Bernard R, Ho DD. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers. PLoS One. 2011;6(5):e19252. doi: 10.1371/journal.pone.0019252. Epub 2011 May 16.
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Zhou J, Cheung AK, Tan Z, Wang H, Yu W, Du Y, Kang Y, Lu X, Liu L, Yuen KY, Chen Z. PD1-based DNA vaccine amplifies HIV-1 GAG-specific CD8+ T cells in mice. J Clin Invest. 2013 Jun;123(6):2629-42. doi: 10.1172/JCI64704. Epub 2013 May 1.
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BACKGROUND
Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, June 2020
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://www.fda.gov/media/73679/download
Accessed on 07 January 2021
https://www.gmp-compliance.org/files/guidemgr/E9-R1_Step4_Guideline_2019_1203.pdf
Accessed on 28 July 2021
https://covid19.who.int/table
Accessed on 28 July 2021
Other Identifiers
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CTC2107
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
PHASE1
Immunogenicity of COVID-19 Vaccine on Heterologous Schedule
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PHASE2
A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
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PHASE1
A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19
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PHASE1
Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine
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COMPLETED
PHASE4
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
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UNKNOWN
PHASE2
Human COVID-19 Immunoglobulin (COVID-HIG) Therapy for COVID-19 Patients
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UNKNOWN
PHASE2