Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05102643
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Immuno Cure 3 Limited
Information provided by (Responsible Party):
The University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: SARS-CoV-2 DNA Vaccine Biological: Matching placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 18, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Product
SARS-CoV-2 DNA Vaccine at 1mg and 2mg, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
Biological: 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).

Placebo Comparator: Reference Product
Matching placebo, 2 doses 3 weeks apart, intramuscular injection followed by electroporation
Biological: Matching placebo
Solution for intramuscular injection




Primary Outcome Measures :
  1. Reactogenicity [ Time Frame: Days 1 to 15 and Days 22 to 36 ]
    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

  2. Adverse Events [ Time Frame: Days 1 to 50(±3) ]
    Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)


Secondary Outcome Measures :
  1. Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by ELISA [ Time Frame: Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits ]
    Measurement of binding antibody responses by ELISA in serum samples

  2. Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay [ Time Frame: Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits ]
    Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102643


Contacts
Layout table for location contacts
Contact: Volunteer Resource Centre 85296812309 ctcvrc@hku.hk

Locations
Layout table for location information
Hong Kong
HKU Phase 1 Clinical Trials Centre Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Immuno Cure 3 Limited
Investigators
Layout table for investigator information
Principal Investigator: Ivan Fan-ngai Hung The University of Hong Kong
Additional Information:
Publications:
SARS-CoV-2 DNA Vaccine - Investigator's Brochure (Version 1.0, Dated 24-Sep-2021).
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.
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

Layout table for additonal information
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05102643    
Other Study ID Numbers: CTC2107
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases