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Covid19Phase 1NCT05102643

A Study to Evaluate Safety & Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19

A Phase 1 study testing SARS-CoV-2 DNA Vaccine in people with Covid19, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
SARS-CoV-2 DNA Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteHong Kong
Study dates
18 Nov 2021to Dec 2022
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • Gender and Age: Male or female, at the age of ≥ 18 and ≤ 55 on the day of signing the ICF.
  • Body Weight and BMI: Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and < 25 kg/m2 at screening and baseline.
  • Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
  • 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;
  • Normal vital signs at screening and baseline, as defined by:
Show all 14Show fewer
  • Body (tympanic) temperature ≤ 37.5oC;
  • Resting pulse rate ≥ 50 and ≤ 100 bpm; and
  • DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
  • Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
  • 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;
  • 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.
  • 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.
  • Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.

Who cannot join

  • Medical History: History of any of the following diseases or conditions:
  • COVID-19;
  • SARS;
  • Any significant respiratory diseases (e.g. COPD, asthma);
  • Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
  • Blood dyscrasias or any significant disorder of coagulation;
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  • Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
  • Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
  • Any malignant neoplastic disease;
  • Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
  • Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
  • Any immunodeficiency or autoimmune disease;
  • Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
  • History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.
  • Medical Conditions or Diagnoses: Existence of any of the following medical conditions or diagnoses:
  • Positive serum pregnancy test at screening or positive urine pregnancy test at baseline (for WOCBP);
  • IgE level > 1,000 IU/ml at screening;
  • Positive SARS-CoV-2 test result in serum or deep throat saliva (DTS) within 4 days prior to baseline;
  • T3, T4 or TSH < LLN or > ULN at screening;
  • Positive HIV test result at screening;
  • Positive HBsAg test result at screening;
  • Positive HCV antibody test result at screening;
  • Positive urine drug screen test result or positive blood alcohol test result at screening or baseline;
  • 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.
  • Prior/Concomitant Interventions: Use of or undergoing any of the following prior or concomitant medications, therapies or interventions:
  • Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination, or planned use of any such vaccine throughout the study;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • Regular use of any topical corticosteroids at or near the intended administration site (upper arm);
  • 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;
  • 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;
  • Donated ≥ 450 ml of blood within 28 days prior to the first vaccination.
  • Prior/Concurrent Clinical Study: Prior or concurrent participation in any other clinical study, including:
  • Prior or current participation in another COVID-19 vaccine study;
  • Prior participation in any interventional clinical study and use of any investigational intervention within 90 days prior to the first vaccination;
  • Concurrent participation or plan for participation in another interventional clinical study during participation in this study.
  • 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.
  • Special Conditions: Existence of any of the following special conditions:
  • Close contact with anyone known to have COVID-19 within 30 days prior to the first vaccination;
  • Travelled outside Hong Kong within 14 days prior to the first vaccination;
  • Planned to travel outside Hong Kong at any time during the period from screening to Day 50(±3) visit.

Trial locations and contacts

1 site in 1 country.

Volunteer Resource Centre contact

85296812309

ctcvrc@hku.hk

Hong Kong1 site, 1 recruiting

  • HKU Phase 1 Clinical Trials Centre

    Hong Kong

    Recruiting

Other trials in Hong Kong

About this study

Official title: A Phase 1, Randomized, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 in Healthy Adults

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.

Read the detailed description

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
Covid19
Being tested
SARS-CoV-2 DNA Vaccine, Matching placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 DNA VaccineBiological

    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).

  • Matching placeboBiological

    Solution for intramuscular injection

Study groups in NCT05102643
Study groupRoleWhat they receive
Test ProductExperimentalSARS-CoV-2 DNA Vaccine at 1mg and 2mg, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
Receives: Biological: SARS-CoV-2 DNA Vaccine
Reference ProductPlacebo comparatorMatching placebo, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
Receives: Biological: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reactogenicity

    Occurrence of solicited local events (pain, tenderness, redness, warmth, itch, swelling, induration) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating) for a 14-day period after each vaccination

    Measured: Days 1 to 15 and Days 22 to 36

  2. Adverse Events

    Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

    Measured: Days 1 to 50(±3)

Secondary outcomes (2)

  1. Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by ELISA

    Measurement of binding antibody responses by ELISA in serum samples

    Measured: Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits

  2. Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay

    Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples

    Measured: Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start18 Nov 2021
  3. Primary completionJun 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Randomised
Intervention model
Sequential
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05102643
Sponsor's protocol ID
CTC2107
Status last verified
Jan 2022
First submitted
29 Oct 2021
Last updated
27 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results of this study will be publicly disseminated by ways of publication(s) in peer-reviewed scientific journal(s), presentation(s) in scientific conference(s), posting on public clinical trial registry(ies) and/or otherwise instead of individual participant data (IPD) sharing.

Publications

  • SARS-CoV-2 DNA Vaccine - Investigator's Brochure (Version 1.0, Dated 24-Sep-2021).

  • 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.

    PubMed 34107529

  • 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.

  • Liu C, Lu Z, Xie Y, Guo Q, Geng F, Sun B, Wu H, Yu B, Wu J, Zhang H, Yu X, Kong W. Soluble PD-1-based vaccine targeting MUC1 VNTR and survivin improves anti-tumor effect. Immunol Lett. 2018 Aug;200:33-42. doi: 10.1016/j.imlet.2018.06.004. Epub 2018 Jun 9.

    PubMed 29894719

  • 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.

    PubMed 16988008

  • 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.

    PubMed 31351922

  • Poland GA, Ovsyannikova IG, Kennedy RB. SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates. Lancet. 2020 Nov 14;396(10262):1595-1606. doi: 10.1016/S0140-6736(20)32137-1. Epub 2020 Oct 13.

    PubMed 33065034

  • Sallberg M, Frelin L, Ahlen G, Sallberg-Chen M. Electroporation for therapeutic DNA vaccination in patients. Med Microbiol Immunol. 2015 Feb;204(1):131-5. doi: 10.1007/s00430-014-0384-8. Epub 2014 Dec 23.

    PubMed 25535102

  • Tan Z, Chiu MS, Yan CW, Wong YC, Huang H, Man K, Chen Z. Antimesothelioma Immunotherapy by CTLA-4 Blockade Depends on Active PD1-Based TWIST1 Vaccination. Mol Ther Oncolytics. 2020 Feb 8;16:302-317. doi: 10.1016/j.omto.2020.01.009. eCollection 2020 Mar 27.

    PubMed 32195318

  • 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.

    PubMed 25125656

  • 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.

    PubMed 33392485

  • Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.

    PubMed 31530680

  • 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.

    PubMed 34125864

  • 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.

    PubMed 21603651

  • Vivarelli S, Falzone L, Torino F, Scandurra G, Russo G, Bordonaro R, Pappalardo F, Spandidos DA, Raciti G, Libra M. Immune-checkpoint inhibitors from cancer to COVID-19: A promising avenue for the treatment of patients with COVID-19 (Review). Int J Oncol. 2021 Feb;58(2):145-157. doi: 10.3892/ijo.2020.5159. Epub 2020 Dec 14.

    PubMed 33491759

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SARS-CoV-2 DNA Vaccine in people with Covid19, run by The University of Hong Kong at 1 site in Hong Kong.

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 14 inclusion and 44 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 27 Jan 2022. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 Volunteer Resource Centre (85296812309, ctcvrc@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reactogenicity (time frame: Days 1 to 15 and Days 22 to 36). The study lists 2 primary outcomes in all. 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 NCT05102643, which also lists 18 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 27 Jan 2022.

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