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

January 26, 2022 updated by: The University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Volunteer Resource Centre
  • Phone Number: 85296812309
  • Email: ctcvrc@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • HKU Phase 1 Clinical Trials Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Days 1 to 15 and Days 22 to 36
Adverse Events
Time Frame: Days 1 to 50(±3)
Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Days 1 to 50(±3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits
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
Day 1(pre-dose), 8(+1), 15(+1), 22(pre-dose), 29(+1), 36(+1) and 50(±3) visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Immuno Cure 3 Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC2107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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